1. Overview

1.1 National context and evidence base

Type 2 diabetes represents a major burden on heath and care services and its increasing prevalence poses a major risk to population wellbeing and the sustainability of the NHS. Helping people with type 2 diabetes achieve significant weight loss and improve glucose regulation is likely to reduce the future risk of complications and associated impacts on wellbeing and healthcare costs.

The NHS Long Term Plan published in 2019 announced that a low calorie diet programme would be piloted, at scale, from 2020/21. This commitment built on the approaches of the Diabetes Remission Clinical Trial (DiRECT), and the Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET) Randomised Control Trials (RCTs), reflecting the evidence base developed by both of these trials.

Following the pilot phase of the programme, NHS England is making this intervention available to the eligible population across all of England.

1.2 Introduction to the NHS Type 2 Diabetes Path to Remission Programme

The NHS Type 2 Diabetes Path to Remission Programme (the “NHS T2DR Programme”) is a joint initiative between NHS England and Diabetes UK (note: the name of the programme is subject to change). The NHS T2DR Programme involves a total diet replacement (TDR) approach that has been shown in RCTs to help some people with Type 2 diabetes achieve and maintain non-diabetic glycaemic levels off all diabetes medication (commonly referred to as remission).

The overall aim of this intervention is to promote weight loss in those that are overweight (BMI of 27 kg/m2 or over in people from White ethnic groups, adjusted to 25 kg/m2 or over in people from Black, Asian and other ethnic groups) and recently diagnosed with Type 2 diabetes, achieving remission wherever possible.

Service users will follow a diet composed solely of nutritionally-complete TDR products, with total energy intake of 800-900 kilocalories a day, for 12 weeks, followed by a period of food reintroduction and subsequent weight maintenance support, with total duration of 12 months.

The provider must offer a variety of TDR products such as soups, shakes and other suitable products. These must include the availability of varied flavours and textures to support service user compliance and retention on the NHS T2DR Programme. The provider must supply the appropriate TDR products to service users but must not supply any service user with more than a four (4) week supply of TDR products at any one time. The provider must ensure that, at all times during the contract term, all TDR products it supplies to service users adhere to all legislation and standards that apply to total diet replacement products. To avoid doubt, this includes any legislation and standards as they may be amended, extended or re-enacted from time to time and including any applicable subordinate or replacement legislation or standards. This includes but is not limited to The Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997 which provide the specific composition and labelling requirements of TDR products. The provider will be responsible for procuring the TDR products that it supplies to service users. The provider must consider the needs of a variety of potential service users, including offering suitable or alternative TDR products where possible for those with intolerances (e.g. lactose intolerance) which may impact on their ability to use certain products.

The identification and referral of people to the NHS T2DR Programme is undertaken by general practice primary care services (see section 3.2.3). Eligible individuals will be aged 18 – 65 years, diagnosed with Type 2 diabetes within the last 6 years and have a BMI of 27 kg/m2 or over in people from White ethnic groups, adjusted to 25 kg/m2 or over in people from Black, Asian and other ethnic groups. Other eligibility criteria also apply and are considered necessary to ensure safety within the context of real-world implementation of this programme. Modelling suggests that 10-20% of those living with Type 2 diabetes would be eligible for the NHS T2DR Programme, once the eligibility criteria are applied (see section 3.2.2 for the full eligibility criteria).

The responsibility of identifying eligible individuals and referring them (once their consent has been obtained) to the NHS T2DR Programme sits with the individual’s GP practice and the provider is required to verify eligibility with the individual confirming that exclusion criteria have not been met prior to commencement of the intervention in accordance with this service specification.

It is intended that, within a defined geographical area, a single provider will deliver the NHS T2DR Programme by offering to individuals the following choice of delivery models:

• One to one face-to-face (the “face-to-face delivery model”);
• One to one digital support (the “digital delivery model”),

References to “the delivery models” in this service specification are references to both delivery models.

References to “sections” in this service specification are references to sections of this service specification.

2. Outcomes

2.1 Expected outcomes of the NHS Type 2 Diabetes Path to Remission Programme

• Reduction in weight of service users and the maintenance of weight loss achieved;
• Reduced glycaemic parameters in service users and achievement of remission of Type 2 diabetes as a result of the intervention;
• Reduction in medication usage among service users in line with the intervention;
• Continue to build the evidence base around the effectiveness of a low calorie diet, total diet replacement programme, including evidence around impact of the intervention in different demographic groups.

3. Scope

3.1 Aims of the service

In order to achieve the outcomes set out in section 2.1, the NHS T2DR Programme will aim to:

• Promote weight loss in those that are overweight (BMI ≥ 27kg/m² in people from White ethnic groups, adjusted to 25kg/m² in people from Black, Asian and other ethnic groups) and recently diagnosed with Type 2 diabetes;
• Support service users to adopt a healthier lifestyle, having appropriate regard to achievement of dietary recommendations in England; and
• Maximise completion rates of service users, including across groups that share a protected characteristic.

The above aims are for the service as a whole, and at an individual service users level goals must be tailored to suit individual service users requirements

3.2 Service description/care pathway

The service will comprise:

• An individual assessment of a service users;
• A period during which the provider will provide TDR products to the service user (the “TDR Phase”);
• A period during which the provider will work with the service user to reintroduce food into the service user’s diet (the “food reintroduction phase”); and
• A period during which the provider will support the service user in maintaining their weight (the “weight maintenance phase”).

3.2.1 Principles

The provider will deliver the Service in accordance with the following principles:

• The provider must provide the service in accordance with this Schedule 2A and the annexes and appendices to this Schedule 2A;
• Delivery of the service will be tailored to the circumstances and cultural context of service users and will be sensitive to different culinary traditions, including where possible for the TDR products themselves;
• The content of the sessions (or, for the digital delivery model, engagement) with service users should aim to empower people with Type 2 diabetes to take a leading role in instituting and maintaining long-term behaviour changes;
• The provider must endeavour to ensure equal access by all service users, reduce health inequalities and promote inclusion, tailoring the service to support and target those with greatest need through a proportionate universalism approach and equality of access for people with protected characteristics under the Equality Act 2010;
• The provider must monitor service performance and inequalities in outcomes and take appropriate corrective action to improve performance and reduce inequalities accordingly. Specific attention should be given to monitoring and improving performance relating to people with characteristics which have been associated with poorer outcomes in the pilots;
• Access to the service will accommodate the diverse needs of the target population in terms of availability, accessibility, customs and location, as far as possible;
• The provider must build relationships and work with relevant local stakeholders (including local health systems and community sector organisations) to deliver a relevant and inclusive programme;
• The provider should maximise the flexibility (within the scope of this service specification) of their offering in order to increase reach for all, including communities who face the most barriers to access;
• The provider should ensure service user involvement and engagement in the design, evaluation and improvement of the service;
• The provider must engage proactively with GP practices whilst ensuring that the impact on workload for GP practices is minimised;
• All individuals must be treated with courtesy, respect and an understanding of their needs;
• The provider must supply to GP practices adequate information on the benefits and risks of the service, in a format which is accessible to potential service users and healthcare professionals. The Provider acknowledges that the purpose of providing this information is to support the GP practices’ staff to provide information to patients, enabling patients to make an informed choice in accepting referral to the service;
• All potential service users must be given adequate information on the benefits and risks of the service, in a format which is accessible to them, once a referral has been made but before the service user begins the service to allow an informed decision to be made by service users before participating in the service;
• All potential service users must also be given information (in compliance with data protection requirements) about how personal data will be used, who will have access to it, and patients’ data protection rights (e.g. how to obtain a copy of personal records, rectification, objection, etc);
• All service users must be given unconstrained choice between the face-to-face delivery model and the digital delivery model, with adequate information provided to allow for an informed decision to be made;
• The provider must provide service users with appropriate support throughout the duration of participation in the service;
• The provider must ensure that persons referred to the service are effectively integrated across a pathway including between the provider of the service and the GP practice with which the person is registered;
• The provider must ensure safe, timely and appropriate communication with relevant GP practices for management of adverse or concurrent medical events and for ongoing management at time of discharge, disengagement or drop out from the intervention;
• The provider must use the template letters to GP practices and service users supplied by the commissioner at all times specified by the commissioner (including, but not limited to, receipt of referral, notification of TDR start, completion of TDR phase, completion of the programme, discharge from programme). These must be used in the manner and form specified by the commissioner;
• The provider must ensure that any contact from GP practices (including, but not limited to, requests for advice on medication adjustments, questions about the referral process, questions about the programme, requests for updates on Service User progress) is responded to appropriately within 5 operational days (for avoidance of doubt, this timeline pertains to answering the query rather than simply providing acknowledgement of having received such contact)
• Improvements and adjustments to the delivery of the service may be identified as new evidence emerges from national and international research and local evaluation of the service. The provider acknowledges and agrees that the service will be adjusted to respond to best available evidence, including (by way of example only) as a result of planned innovation-testing evaluation (e.g. a research project or time-limited pilot of a local innovation to improve the service). Any such adjustments would be effected as a variation to this contract in accordance with the variation procedure set out in general condition 13 (variations);
• If the provider identifies emotional wellbeing or mental health issues, the provider should signpost the service user to appropriate local services through a process agreed with the local health system prior to the expected services commencement date.
• If the provider suspects or identifies behaviours that meet the threshold of an eating disorder during the course of the sessions, the GP practice should be notified and the Service User should be advised to seek care with their GP practice accordingly. In addition, identification of an active eating disorder should be recorded as an adverse event and the process for adverse events followed (as set out in Section 3.2.12).
• The provider must actively encourage and respond to service user feedback. This should be sought on all aspects of the service including the curriculum, programme structure, frequency of support, TDR products, coaching, approach to meeting individual, cultural adaptation, support materials and functionality/usability of any digital tools. The provider must have effective governance processes for collating and actioning such feedback as well as for responding to any complaints.

In the event and to the extent only of a conflict between any of the provisions of this service specification and appendix 1 (tender response document) and/or appendix 2 (local service requirements) of this schedule 2A, the conflict shall be resolved in accordance with the following descending order of precedence:

• this service specification;
• Appendix 1 of schedule 2A (tender response document);
• Appendix 2 of schedule 2A (local service requirements).

Where appendix 1 of schedule 2A (tender response document) or appendix 2 of schedule 2A (local service requirements) contains provisions which are more favourable to the commissioner in relation to the Service Specification and/or Appendix 1 of Schedule 2A (tender response document) as relevant, such provisions of Appendix 1 of Schedule 2A (tender response document) or Appendix 2 of Schedule 2A (local service requirements) shall prevail.

The commissioner shall in its absolute and sole discretion determine whether any provision in Appendix 1 of schedule 2A (tender response document) or appendix 2 of schedule 2A (local service requirements)) is more favourable to it in relation to the service specifications and/or appendix 1 of schedule 2A (tender response document) as relevant.  

3.2.2 Eligible population

Individuals who satisfy all the following eligibility criteria may be referred to the service:

• Aged 18 to 65 years;
• Diagnosed with type 2 diabetes within the last 6 years;
• A BMI of 27kg/m² or higher in people from White ethnic groups, adjusted to 25kg/m² or higher in people from Black, Asian and other ethnic groups.
  • BMI obtained from self-measured weight by a service user is acceptable for referral. If this cannot be obtained, a clinic-measured value within the last 12 months may be used, provided there is no concern from the referrer that the service user’s weight may have reduced since last measured such that the individual would not be eligible for the service at present;
• A HbA1c measurement taken within the last 12 months, with values as follows:
  • If on diabetes medication, HbA1c 43 to 87 mmol/mol; or
  • If not on diabetes medication, HbA1c 48 to 87 mmol/mol;

provided there is no concern from the referrer that the service user’s HbA1c may have changed since last measured such that the individual would not be eligible for the Service at present; and

• Have attended for monitoring and diabetes review when this was last offered, including retinal screening, and commit to continue attending annual reviews, even if remission is achieved. (For avoidance of doubt, if a service user is newly diagnosed then there is no requirement to wait for retinal screening to take place before offering referral)

Individuals who meet any of the following exclusion criteria must not be referred to the service and must not be accepted by the provider. The provider must confirm that the individual is eligible and so does not meet any of the following exclusion criteria prior to the individual’s commencement of the intervention:

• Current insulin user;
• Pregnant or planning to become pregnant within the next 6 months;
• Currently breastfeeding;
• Discharged in the last 12 months from the NHS Type 2 Diabetes Path to Remission Programme after having commenced the programme (for clarity, this does not apply to people previously referred to the programme but who dropped out or declined prior to commencing the TDR Phase);
• Has at least one of the following significant co-morbidities;
  • active cancer;
  • heart attack or stroke in last 6 months;
  • severe heart failure (defined as New York Heart Association grade 3 or 4);
  • severe renal impairment (most recent eGFR less than 30mls/min/1.73m2);
  • active liver disease other than non-alcoholic fatty liver disease (NAFLD) (i.e. NAFLD is not an exclusion criterion);
  • active substance use disorder;
  • active eating disorder (including binge eating disorder);
  • porphyria; or
  • known proliferative retinopathy that has not been treated (this does not exclude individuals who are newly diagnosed and have not yet had the opportunity for retinal screening);
• Has had bariatric surgery; or
• Health professional assessment that the person is unable to understand or meet the demands of the NHS T2DR Programme and/or monitoring requirements (due to physical or psychological conditions or co-morbidities).

At time of referral to the service, the referrer is responsible for discussing and agreeing any relevant medication changes with the potential Service User. The provider must take steps to ensure that referrers can obtain advice from the provider regarding medication changes and the provider must ensure that communication in this regard is facilitated between referrers and the provider’s medical director (or another suitably experienced registered medical practitioner within the meaning of schedule 1 of the Interpretation Act 1978 with an MRCP or MRCGP). Any requests for advice should be responded to with appropriate advice within 5 operational days. The provider acknowledges that clinical responsibility for an individual’s medication changes remains with general practice at all times that the individual is associated with the Service.

It should be made clear by the referrer to the potential service user that these changes should only be enacted on the first day of starting the TDR intervention. The provider must be aware of whether any potential Service User has a medication change or not.  The provider must ensure that it has received in writing from the referrer either details of medication changes or confirmation that no medication changes are required. The provider must ensure the potential service user is also aware of the medication changes proposed (or that no medication changes are required) although there is no requirement for this to be have submitted to the service user by the referrer in writing. The provider must ensure that, prior to the first day of TDR Phase, the service user understands the specific medication changes which are required (or that no medication changes are required). The referrer should also confirm with the Service User that, should they proceed on the NHS T2DR Programme, the service user:

• Agrees to continue attending yearly diabetes review appointments at their GP practice, regardless of whether remission is achieved;
• Will contact their GP practice or urgent care service as appropriate if they have any unexpected or concerning symptoms which are considered urgent; and
• Will notify their GP practice if they disengage or drop out before the end of their intervention.

The provider is required, as set out in more detail in section 3.2.5, to confirm that it and the Service User have been provided with information relating to medication changes prior to commencement of the intervention.

3.2.3 Referral and acceptance

The service will commence when the provider begins to accept referrals from the local health systems. As set out in general condition 3 of the contract, the date the provider is required to commence the service (and so accept referrals) is the later of:

• the expected services commencement date; and
• the day after the date on which all conditions precedent are satisfied.

The provider and the commissioner may agree to substitute the expected services commencement date with any earlier date in which case the contract will be varied in accordance with its provisions.

The provider will develop and agree detailed referral protocols with local health systems prior to receiving referrals to the service. Referrals will come from GP practices.  If there is agreement by the provider, the local health system and the commissioner, the Parties may agree to amend this service specification to include other referral routes.

All individuals who satisfy the eligibility criteria and are not excluded in accordance with section 3.2.2 will be invited by the provider to participate in the Service as further detailed in section 3.2.4.

The first communication sent by the provider to the relevant service user’s GP practice on receipt of a referral should make clear that any changes in eligibility to participate in the Service or medication changes (including in particular (but not limited to) new glucose-lowering agents / BP-lowering agents) should be communicated urgently to the provider. The provider will confirm with the relevant Service User, prior to starting the TDR Phase, that they have not started any new medications (including in particular (but not limited to) glucose-lowering or blood pressure-lowering medications) since medication changes to take place on the first day of TDR were agreed with their referrer. Where there is concern such changes may have occurred and may require re-consideration of medication changes (e.g. if new glucose-lowering agents / BP-lowering agents have been started), the provider should contact the GP practice for confirmation that it remains appropriate for the Service User to proceed with the TDR Phase and to request an update on medication changes to take place on the first day of TDR (these would need to be agreed by the referrer and Service User).

3.2.4  Invitation to participate

Subject to the intervention cap and intervention period (referred to in section 3.10), the provider will invite all eligible, referred individuals to participate in the service.

The provider will initiate contact with each individual directly referred to them (where there is no evidence for ineligibility), within five operational days of receipt of the referral, inviting the individual to participate in the service. The individual must be provided with adequate information about the delivery models to allow for an informed, unrestricted choice about which delivery model would better suit their needs and individual context.

The provider will work with local health systems to manage the trajectory of referrals in line with the volume of contracted interventions and work together with the local health system and with the commissioner to match supply and demand across the duration of the contract. 

The invitation and all follow-up contact will contain accessible information about Type 2 diabetes, the potential to achieve remission, the nature of the intervention and the requirements for service users. All contact made with individuals should be grounded in behavioural insight theory and evidence.

Where there is no response from the individual as a result of the initial invitation, the provider must make at least two additional attempts to contact that individual via at least two of the following methods within a period of one calendar month from the date of receipt of referral: letter, phone call, text message or email.

Where contact has not been established after one month 

If it has not been possible to make contact after a minimum of three attempts and through at least two different channels after one calendar month, the Provider must discharge the individual back to their GP practice. The provider must also communicate a discharge notice to the individual and signpost the individual to the NHS website pages related to weight management, appropriate physical activity and healthy lifestyles and to any other locally available resources for supporting weight loss, healthy eating and appropriate physical activity.

Where contact has been established

Where contact has been established but an individual indicates that they do not accept an invitation to participate in the Service, then the provider must discharge that individual back to the GP practice. The Provider must communicate a discharge notice to the individual’s GP practice and the individual and signpost that individual to the NHS website pages related to weight management, physical activity and healthy lifestyles and to any other locally available resources for supporting weight loss, healthy eating and physical activity.

Where contact has been established and an individual accepts an invitation to participate in the service, the provider must offer as much choice of dates and times (and, for face-to-face delivery models, appropriate venues) as logistically possible, where applicable, to attend or participate in an Individual Assessment (which is explained further in 3.2.5 below) provided that the dates and times offered by the Provider are within a period of one calendar month of the date the provider established contact with the individual and the individual accepted the invitation to participate in the service. If driven by service user choice and a decision to defer starting the TDR Phase to a more suitable time, Individual Assessment may occur within 90 days of the referral.

At the point the individual accepts the offer to attend or participate in the individual assessment, that individual is considered to be a Service User.

The provider must comply with any template letters or discharge communication content that the commissioner notifies the provider must be used. The provider must ensure sound data collection mechanisms are in place to support evaluation of the service in achieving defined outcomes and enable the assessment over time of progress relating to diabetes remission and reductions in the long term complications of Type 2 diabetes and associated morbidity and mortality.

In addition to use of the template letters, the provider will work closely with the local health system to identify and implement any further locally appropriate mechanisms for ensuring data about a Service User is communicated to the GP practice with which the service user is registered (using SNOMED codes where appropriate) and that such data can be integrated within GP clinical systems; ideally by electronic transfer. The provider will also work with the local health systems to ensure that there is a monthly update on referral and uptake rates, waiting list size and outcomes at locally-agreed levels; e.g. at the level of individual GP practices, primary care networks (PCNs) or ICSs.

The Provider must highlight to the commissioner and the local health system any issues in relation to referrals and uptake into the service and any deviation from the expected referral and uptake numbers (as agreed with the local health system).

Additionally, the provider must notify GP practices about progression of service users through the service through use of the template letters provided by the commissioner in addition to any further locally agreed means.

3.2.5 Individual assessment

The provider will conduct individual assessments with all service users who accept the invitation to participate in the service (“individual assessment”).

The provider will use individual assessments to:

• verify the eligibility of the service user;
• explain in detail the rationale and requirements of the service; and
• determine whether the service user wishes to continue with the service.
• confirm the service user’s choice of delivery model.

If the Service User chooses to proceed to the TDR Phase, the provider will set a mutually-agreeable start date with the service user and confirm matters relating to any medication changes that will be enacted by the Service User on this same date as set out in this Service Specification.

The individual assessment may be undertaken remotely in the face-to-face delivery model providing this does not restrict the individual assessment process in any way and allows for the required information to be obtained and eligibility to be verified. (It is expected that all individual assessments will occur remotely in the digital delivery model).

Following the individual assessment, confirmation of the individual assessment must be sent to the service user’s GP practice. This should include:

• notification regarding whether the service user intends to proceed to the TDR Phase;
• details of the mutually-agreed start date of the TDR Phase;
• confirmation of any medication changes which will be enacted on the first day of the TDR Phase (or that no changes are required) (as communicated to the service user and supplied in writing to the provider by the referrer); and
• confirmation that the service user:
  • agrees to continue attending yearly diabetes review appointments at their GP practice, regardless of whether remission is achieved;
  • will contact their GP practice or urgent care service as appropriate if they have any unexpected or concerning symptoms which are considered urgent; and
  • will notify their GP practice if they disengage or drop out before the end of the intervention.

Data must be gathered at all points of Service delivery in accordance with the requirements of this service specification and Schedule 6A. If a specific data item is indicated in Schedule 6A to be gathered at a specific point of service delivery, the Provider will gather such data item.

If a service user has previously accepted the service but fails to attend or participate in a scheduled and agreed individual assessment, the Provider must make at least two further attempts to offer an individual assessment at times appropriate to the service user provided that such times are within one calendar month of the date the service user failed to attend or participate in the scheduled and agreed Individual Assessment, but no later than 90 days following referral. If the service user does not complete an individual assessment during this time, the service user should be discharged back to their GP practice, signposting the service user to the NHS website pages related to weight management, physical activity and healthy lifestyles and to any other locally available resources for supporting weight loss, healthy eating and physical activity.

If, following the individual assessment, a service user:

• does not attend or participate in the first session (or, in the digital delivery model, the first episode of engagement) within 90 days of individual assessment;
• does not attend or participate in the first session (or, in the digital delivery model, the first episode of engagement) after the Provider has offered the first session (or, in the Digital Delivery Model, the first episode of engagement) on three separate occasions at times, and for the face-to-face delivery model, venues, appropriate to the service user;
• defers attendance at or participation in the session (or, in the digital delivery model, the first episode of engagement) after the Provider has offered the first session (or, in the digital delivery model, the first episode of engagement) on three separate occasions at times, and for the face-to-face delivery model, venues, appropriate to the service user; or
• declines the service,

the Service User should be discharged back to their GP practice, signposting the service user to the NHS website pages related to weight management, physical activity and healthy lifestyles and to any other locally available resources for supporting weight loss, healthy eating and physical activity.

The provider must offer the first session (or, in the digital delivery model, the first episode of engagement) within 30 days of the individual assessment. For the face-to-face delivery model, this must be at a venue appropriate to the service user. If driven by service user choice and a decision to defer starting the TDR Phase to a more suitable time, the first session may occur within 90 days of the individual assessment.

If the provider cancels any booked session (or, in the digital delivery model, any booked episode of engagement) for any reason at any time during a service user’s participation in the service, the provider must promptly reschedule the service user’s session (or, in the digital delivery model, the episode of engagement).

The provider must record details about the number of contact attempts made to offer the service, arrange individual assessments and rearrange sessions (or, in the digital delivery model, episodes of engagement) including date and method of contact as set out in this section.  The provider is required to record all of this information under Schedule 6A and must share this information with the commissioner in accordance with the requirements of this contract and, if relevant, at any other time requested by the commissioner.

Intervention commencement

Following the individual assessment, if the service user has decided to proceed with the TDR Phase, the Provider must notify the service user’s GP practice of the agreed start date of the TDR Phase. This must be within 90 days of the individual assessment. Although necessary medication changes, if applicable, should have been discussed at time of referral, any changes must not be enacted by the service user until the first day of the TDR Phase. The provider must, prior to the first day of the TDR intervention:

• ensure that the provider and the service user understand the specific medication changes which are required (or that no medication changes are required) and the provider has received details of changes (or confirmation that no change is necessary) in writing from the referrer;
• confirm that no additional glucose-lowering or blood pressure-lowering medications have been started since medication changes were last agreed (including if the recommendation was for no medication changes to take place) and specified in writing to the Provider and communicated to the Service User); and
• confirm with the service user that they will not be taking sulphonylureas, meglitinides or SGLT2 inhibitors as of the first day of the TDR intervention.

If the Provider:

• cannot confirm that the provider and the service user have been provided with confirmation from the referrer of the specific medication changes which are required (or that no medication changes are required); and/or
• cannot confirm that no additional glucose-lowering or blood pressure-lowering medications have been started since medication changes were last communicated by the referrer (including communication of no medication changes to be made); and/or
• cannot confirm with the service user that they will not be taking sulphonylureas, meglitinides or SGLT2 inhibitors (if applicable) as of the first day of the TDR intervention,

then the provider must defer the service user’s TDR Phase start date and take such action as it necessary to ensure that the above matters are confirmed. Once the matters above have been confirmed, the Provider must promptly arrange the service user’s commencement of the TDR Phase.

3.2.6 Intensity and duration of the Service

The provider must deliver the service in accordance with the requirements set out in this section.

TDR Phase

• The TDR Phase begins from the first day the service user starts taking TDR products and lasts for 12 weeks.
• An individual should not start taking TDR products and/or commence the TDR Phase or a rescue package (as defined later in this Specification) at any time if they are taking sulphonylureas, meglitinides or SGLT2 inhibitors.
• If the Service User cannot confirm to the Provider that they are not taking sulphonylureas, meglitinides or SGLT2 inhibitors during the TDR Phase or at the commencement of a rescue package or the recommencement of the TDR Phase following a planned pause, the Provider should contact the Service User’s GP practice to obtain confirmation as to whether the Service User is or is not taking sulphonylureas, meglitinides or SGLT2 inhibitors. An individual should not start taking TDR products and/or commence or re-commence the TDR Phase or a rescue package (as defined later in this Specification) at any time unless it is confirmed that they are not taking sulphonylureas, meglitinides or SGLT2 inhibitors.
• If the Service User confirms to the Provider that they are taking sulphonylureas, meglitinides or SGLT2 inhibitors during the TDR Phase or at the commencement of a rescue package, the Provider must advise the Service User to cease taking TDR products immediately and the Provider must refer the Service User to their GP practice.
• The Provider must provide TDR products to each Service User for the duration of that Service User’s participation in the TDR Phase. The Provider must offer a variety of TDR products such as soups, shakes and other suitable products. These must include the availability of varied flavours and textures to support service users’ compliance and retention on the Service. The Provider must not supply any Service User with more than a four (4) week supply of TDR products.
• The Contract requires the Provider to perform all its obligations under this Contract in accordance with the Law (as set out in Service Condition 1.1). This requires the Provider to comply with all applicable legislation in relation to the TDR products. The Provider is also required to ensure all TDR products provided to a Service User comply will all standards that are applicable to total diet replacement products. To avoid doubt, this includes any legislation and standards as they may be amended, extended or re-enacted from time to time and including any applicable subordinate or replacement legislation or standards.
• Subject to the three bullet points immediately following this bullet point, TDR products must be provided to replace all daily meals from the first session (or, in the Digital Delivery Model, the first episode of engagement) of the TDR Phase for 12 weeks, with support to ensure that service users can adhere to the regimen. Total energy intake should be 800 – 900 kilocalories daily.
• If during the TDR Phase or during the use of a rescue package, the BMI of the Service User has decreased below 21 kg/m2 in people from White ethnic groups or below 19 kg/m2 in people from Black, Asian and other ethnic groups, the Provider must cease TDR for the Service User and move the Service User to the Weight Maintenance Phase.
• Where service users are unable to comply with full TDR and are at high risk of dropping out of the NHS T2DR Programme, they may, at any point, introduce firstly a single meal of non-starchy vegetables. If they remain at high risk of disengagement, they may further substitute a single TDR meal for a nutritionally appropriate meal of no more than 300 calories.  The Provider must set out the point at which service users start to replace TDR products with an alternative meal. 
• If an individual Service User has specific needs that can’t be addressed due to a lack of any compliant TDR product then consideration can be given to alternative approaches for that individual Service User.
• All service users must receive fibre supplements from the Provider prior to starting the TDR Phase (and any subsequent periods of TDR such as rescue packages) and the Provider will advise service users that they should start taking these from the first day of TDR. The dose provided will equate to 7g per day (usually issued in 2 x 3.5g portions of Ispaghula Husk/Psyllium Husk/Fybogel) during the TDR Phase (and during any rescue packages). Service Users will continue to receive these supplements from the Provider until the relevant Service User advises the Provider that these are no longer necessary. Service Users may be able to stop the fibre supplement on re-introducing meals in the food re-introduction phase. After stopping or decreasing fibre supplementation, if a Service User subsequently indicates a need for further fibre supplementation, the Provider will provide the Service User with further fibre supplements and will continue to provide these.
• If the Service User becomes pregnant, the Provider must immediately discharge the Service User from the Service to the care of the Service User’s GP practice.
• If during the TDR phase or Food Reintroduction Phase the provider becomes aware that a Service User has been diagnosed with any of the co-morbidities as set out in section 3.2.2 Eligible Population, the provider must stop the Service User’s use of TDR products. The providers Medical Director will determine whether it is appropriate for the Service User to move to the Weight Maintenance phase or whether the Service User should be discharged.
• If during a Rescue Package the provider becomes aware that a Service User has been diagnosed with any of the co-morbidities as set out in section 3.2.2 Eligible Population, the provider must stop the Service User’s use of TDR products. The providers Medical Director will determine whether it is appropriate for the Service User to continue with the Weight Maintenance phase or whether the Service User should be discharged.
• If an adverse event occurs that is not defined in the list of co-morbidities as set out in section 3.2.2 Eligible Population, the Provider’s Medical Director will decide whether it is appropriate to stop the Service User’s participation in the TDR Phase but enable the Service User to continue participation in the Service within the requirements of the Service Specification or whether the Service User should be discharged. If the Provider’s Medical Director decides that it is appropriate to enable the Service User to continue with the Service despite the adverse event, the Service User will progress to the Food Re-introduction Phase and then to the Weight Management Phase in accordance with this Service Specification unless any relevant variations to this Service Specification are agreed in relation to that Service User in advance by the Commissioner. If it is established that the Service User cannot tolerate the TDR products within the first 2 weeks of the TDR Phase, the Provider must discharge the Service User from the Service to the care of the Service User’s GP practice.
• The Provider must ensure that service users receive appropriate advice, tools and support in preparation for the Food Re-introduction Phase and the transition to healthy eating. This includes healthy dietary plans appropriate to their preferences and culinary traditions.

Food re-introduction phase

• This phase immediately follows the 12 week TDR Phase and lasts for 6 weeks.
• Service users will gradually re-introduce food using a stepped approach.
• At the latest, the Service User should have ceased using TDR products by the end of 18 weeks following commencement of the TDR Phase.
• During this Food Re-introduction Phase the focus is on the transition from TDR to a balanced diet.
• The Provider must support the Service User to achieve appropriate calorie intake and nutritional balance from food, with targets set according to the Service User’s preference for maintaining their weight or aiming for further controlled weight loss and improved diet quality through nutritional and behaviour change support.
• Advice and dietary plans should be tailored to the Service User’s individual needs, preferences and culinary traditions.

Weight maintenance phase

• This phase follows the Food Reintroduction Phase and comprises the remainder of the programme. The programme is 52 weeks in total.
• During this Weight Maintenance Phase the focus is per Service User preference, for maintaining a steady weight or aiming for further controlled weight loss (except that if the BMI of the Service User has decreased below 21 kg/m2 in people from White ethnic groups or below 19 kg/m2 in people from Black, Asian and other ethnic groups as set out in the section under TDR Phase above, the Provider must not support further weight loss) and ensuring changes are embedded for the longer term. 
• The Provider must support the Service User to set tailored achievable short, medium and long term dietary and physical activity goals.
• The Provider must support the Service User to ensure appropriate energy intake, and steady increases in appropriate physical activity to meet their individualised weight maintenance goals.
• If a Service User regains 2kg or more, with reference to the lowest weight recorded for that Service User since the completion of the TDR Phase, at any time during the Weight Maintenance Phase, the Provider must offer Service User a relapse management protocol, also referred to as a “rescue package”, which includes the reintroduction of TDR for a period of 4 weeks with weekly support sessions.
• The Provider must ensure that the default offer for the rescue package is full TDR for a period of 4 weeks and the Provider must encourage the Service User to accept full TDR. If, however, full TDR is declined by the Service User, a partial rescue package may be offered, consisting of 2 meals replaced with TDR products for a period of 4 weeks. Regardless of whether the rescue package is full or partial, the Provider must ensure there are weekly support sessions during the period of the rescue package;
• The Provider shall not put in place more than one rescue package for any Service User and shall not put in place a rescue package for any Service User after the end of week 42 (as calculated in accordance with the “Minimum session/engagement requirements” section below).
• The Provider will closely monitor and support the Service User during the rescue package. This should be in line with the monitoring requirements of the TDR Phase, with blood glucose and weight measurements taken weekly. Where a Service User is on medication(s) that affects blood pressure (this may include medications used for other purposes such as diuretics for heart failure or alpha-blockers for BPH), the Service User should return to weekly blood pressure monitoring during the rescue package.
• The Provider must put in place an individualised plan for each Service User for food re-introduction for that Service User following a rescue package being implemented. The food re-introduction plan may be up to 6 weeks in duration.

Minimum session/engagement requirements

For the face-to-face delivery model, the service must consist of defined sessions.

For the Digital Delivery Model the Service must consist of defined contacts or episodes of engagements between the Provider and the Service User. The minimum requirements of these defined contacts or episodes of engagement are set out in sections 3.2.8 and 3.2.9. Engagement methods that are relevant to the different Milestones are set out in Schedule 3C.

These episodes of engagement or contacts, that comply with the minimum requirements set out in section 3.2.8 and 3.2.9 (as applicable) and as referred to in Schedule 3C are referred to simply as episodes of engagement in this Service Speciation.

The minimum defined episodes of engagement are set out below.

Additional sessions (or, in the Digital Delivery Model, episodes of engagement) may be provided to support engagement, retention and achievement of intended outcomes. 

The Provider must provide the following minimum sessions (or, in the Digital Delivery Model, episodes of engagement) with a Service User during the Service, constituting an overall minimum of 20 sessions (or, in the Digital Delivery Model, episodes of engagement):

• minimum of 8 sessions (or, in the Digital Delivery Model, episodes of engagement) in the first 12 weeks – these must take place weekly for weeks 1 – 4 (or more frequently at the discretion of the Provider), and fortnightly in weeks 5 – 12 (or more frequently at the discretion of the Provider);
• minimum of 4 sessions (or, in the Digital Delivery Model, episodes of engagement) in weeks 13-18 – these must take place weekly for weeks 13 – 14 (or more frequently at the discretion of the Provider), and fortnightly in weeks 15 – 18 (or more frequently at the discretion of the Provider); and
• minimum of 8 sessions (or, in the Digital Delivery Model, episodes of engagement) in weeks 19 – 52 (these must occur monthly or more frequently at the discretion of the Provider)
• weekly sessions (or more frequently at the discretion of the Provider) during a rescue package after week 19 (i.e. during the Weight Maintenance Phase). The Provider expressly acknowledges that the all of the minimum requirements set out in the three preceding bullet points still comply even where a rescue package is put in place.

For the avoidance of doubt, week 1 begins on the first day of the TDR Phase. 

The first session of (or, in the Digital Delivery Model, the first episode of engagement within) the TDR Phase must not be undertaken at the same time as the Individual Assessment.

The Provider’s achievement of Milestone 1 will be subject to the relevant Service Achievement Criteria, as set out in Part 1 of Schedule 3C. 

The planned participation of a Service User in the Service should be 52 weeks in total from the first day of the TDR Phase. 

Additional contact outside of the minimum sessions (or, in the Digital Delivery Model, episodes of engagement) to further engage and support service users, to encourage retention is encouraged.

If a Service User has missed a session (or, in the Digital Delivery Model, an episode of engagement), additional contact to explore any barriers to engagement, re-engage them and cover missed content is encouraged.

The Provider should consider how it ensures that service users are given appropriate support which is aligned to their needs, preferences and individual circumstances, including cultural context.

Service users should be made aware of the availability of peer support throughout the intervention. If the Service User accepts the offer of peer support, this should be facilitated by the Provider.

Sessions (or, in the Digital Delivery Model, episodes of engagement) must be offered at a range of times and days (and, for the face-to-face delivery models, venues) and where logistically possible in accessible locations to maximise access to (and therefore uptake of) the Service, particularly for those of working age, from ethnic minority groups and from more socially deprived backgrounds. 

Planned pauses

If otherwise at risk of disengagement from the programme due to life circumstances or external factors, a planned pause by a Service User of up to 4 weeks can take place during any phase of the programme after the start of the TDR Phase.  Where a pause is arranged, the Provider must share the details of the pause with the Service User’s GP practice. If the Service User is not able to re-start the programme within 4 weeks of commencing the pause, the Service User should be discharged.

If, following discharge, the individual subsequently requests to re-start the programme, the Provider must inform the individual that they will need to be re-referred by their GP practice. If they had previously commenced the TDR Phase of the programme, they should be informed that they will not be accepted on to the programme until a period of 12 months has elapsed since the date that individual was discharged.

Where a Service User restarts the programme within 4 weeks after an agreed planned pause, the calculation of:

• that Service User’s progression on the programme;
• the Milestone 2 Period; and
• the Milestone 3 Period,

must not take into account the period of the pause. For example, if a Service User commences an agreed planned pause at the end of week 14 and the pause lasts 2 weeks, on re-starting the programme, the Service User should be treated as starting week 15 of the programme. 

Where a Service User commences an agreed planned pause during a rescue package, the rescue package is treated as having ended on the commencement of the pause.

3.2.7 Content of sessions/episodes of engagement

The sessions (or, in the Digital Delivery Model, episodes of engagement) must support behaviour change, supporting compliance with TDR during the TDR Phase or during a rescue package. During the Food Re-introduction Phase and the Weight Maintenance Phase, the sessions (or, in the Digital Delivery Model, episodes of engagement) must provide information and practical tools on nutrition, behaviour change and weight management based on current national guidance as set out in section 4.1.

The content must consider the social and psychological support needed to support people to implement behaviour changes in environments which promote unhealthy behaviours.

The Provider must consider the relationship between the dietary treatment and the behavioural support as described in section 3.2.10 to ensure a coherent programme with logical progression.

For the Digital Delivery Model, the programme material should be designed to allow service users with different levels of knowledge and different approaches to learning to progress at different paces, with an appropriate reading age to optimise accessibility.  This should include promoting self-directed learning.

The Provider must emphasise to service users the importance of continuing to attend for diabetes reviews at their GP practice, regardless of the outcome achieved with the Service.

3.2.8 Delivery of sessions for the face-to-face delivery model

Where the Provider delivers the face-to-face delivery model to a service user, it must comply with this section.

The provider’s service model must ensure that all of the minimum sessions set out in section 3.2.6 are delivered one to one, face-to-face in-person between a service user and the provider if the Service User so chooses. The provider must ensure that the opportunity to have all minimum sessions provided one to one face-to-face in-person is made expressly clear to all service users.

Where there is evidence that it will support delivery and participant engagement, and where the Service User:

• declines a one to one face-to-face in-person session; or
• cannot attend a scheduled one-to-one, face-to-face in-person session; or
• expresses a clear preference (unaffected by any influence of the Provider) for a session to be delivered in a manner other than one-to–one, face-to-face in-person,

a session may be delivered through other delivery mechanisms that involve Provider and Service User contact (options include, but are not limited to, telephone calls or video calls). Any such delivery through other delivery mechanisms must be driven by Service User choice. The Provider must not seek to influence the Service User’s choice of delivery mechanism for any session. Where a Service User chooses or prefers one-to–one, face-to-face delivery, the Provider must not require a Service User to have a session delivered through other delivery mechanisms. Whichever mode of delivery is used, the requirements for monitoring and recording weight, blood glucose and, where applicable, blood pressure, remain (although it is acceptable for such readings to be obtained through self-measurement if a session is not delivered face-to-face in-person). Regardless of whether a Service User chooses that one or more sessions are delivered through other mechanisms, the Provider must ensure that for each Service User, the majority of the minimum sessions are delivered one-to–one, face-to-face and in-person.

Further individual contact, in addition to the minimum sessions set out in section 3.2.6, may also be included to enhance engagement and retention. Where requested by the Service User, the Provider should support attendance by a family member or carer. 

Service users should be offered a choice of dates and times for sessions to encourage attendance and also to offer the opportunity to catch up where they have missed a session. This choice should be available throughout a Service User’s participation in the Service. The Provider should consider the extent to which the intervention is delivered in a logical progression.

References to delivery of a session “in-person” in this section 3.2.8 means the session will be delivered with the Service User and the Staff delivering the session being physically present at the same location. The Commissioner may notify the Provider that all or some of the sessions must be delivered remotely i.e. with the Services User and the Staff delivering the session not being physically present at the same location but having contact through a suitable online platform such as MS Teams, Zoom or Skype or other similar platform (“Remote Delivery”).

At any time during the Contract Term, on one or more occasions the Commissioner may at its absolute discretion require the Provider to change the method of delivery of the sessions to Remote Delivery or back from Remote Delivery to the in-person delivery, as the case may be.

If the Commissioner requires the Provider to change the method of delivery of the sessions to Remote Delivery, the Commissioner will notify the Provider in writing and the Provider will change the method of delivery of the sessions as soon as reasonably practicable following receipt of the notification and in any event in accordance with any timescales specified in the notification. If the Commissioner requires the Provider to change the method of delivery of the sessions from Remote Delivery to in-person delivery, it shall give the Provider notification in writing and the Provider will change the method of delivery of the sessions no later than 3 months following receipt of the notification.

The Provider will ensure that at all times during the Term it has all necessary premises and equipment available to provide in-person delivery and Remote Delivery of the sessions and it will provide service users with such equipment if necessary to change the method of delivery of the sessions to Remote Delivery.

If the Commissioner requires the Provider to change the method of delivery of the sessions, the Provider will notify all affected service users of the change in writing as soon as reasonably practicable, including details of how they can attend/access sessions under the new method of delivery. If a Service User’s first session is held via in-person delivery and the Commissioner requires the Provider to change the method of delivery of the sessions to Remote Delivery, the Provider will ensure that all service users that are affected by the change are given the option to continue to attend/access the sessions via Remote Delivery even if the commissioner subsequently requires the Provider to change back to in-person delivery. If a Service User’s first session is held via Remote Delivery following a requirement from the Commissioner that the Provider changes the method of delivery, the Provider will continue to provide the Service to that Service User via Remote Delivery for the duration of that service user’s participation in the Service even if the commissioner subsequently requires the Provider to change the method of delivery to in-person Delivery.     

For the avoidance of doubt, the Provider’s consent is not required for the Commissioner to require the Provider to change the method of delivery of the sessions and General Condition 13 does not apply to such a change.

The Service Price (as defined in Schedule 3C) will not be varied as a result of the Commissioner requiring the Provider to change the method of delivery of the sessions.

3.2.9  Delivery of episodes of engagement for the Digital Delivery Model

The Provider must deliver the Digital Delivery Model in accordance with the following minimum requirements:

• The Provider must ensure that, in complying with the minimum engagement requirements detailed in section 3.2.6, there is contact between the service user and staff of the provider at each episode of engagement.
• In addition to one-to-one episodes of engagement with the service user, engagement may also be characterised by the interest and subjective experience of using the intervention, combined with the amount, frequency, duration and depth of usage. Such engagement might include: viewing materials, completing an education module or educational materials via a digital application or digital platform, completing a quiz, completing any active elements, use of tracking technology with associated data logged in the digital platform or application and, inputting self-monitoring data. For clarity, such engagement is in addition to one-to-one episodes of engagement and may not be used as a replacement for human coaching.
• Engagement would not include passive receipt of emails and other communications unless it could be demonstrated that these have been actively read through Service User feedback mechanisms embedded into the communication. Schedule 3C sets out the specific types of engagement methods that the Provider must ensure are used for payments to be claimed.
• The Provider must be able to demonstrate that their curricula/modules are designed to deliver engagement of service users for a minimum of twelve months.
• To ensure engagement is spread over twelve months, the Provider must ensure there are episodes of engagement at the frequency indicated in section 3.2.6. Schedule 3C (Local Prices) sets out the specific requirements that need to be met for payment.
• Subject to this section 3.2.9, access to the Service should be flexible to accommodate Service User preferences about accessing the Service at a time of their choosing and to work through content within the required frequency flexibly at their own pace.

3.2.10 Underpinning theory and development of approach

The Provider should be explicit regarding the behavioural change theory and techniques that are being used, and the expected mechanism of action of their intervention (Evans et al, 2022).

This must utilise a behaviour change framework which is evidence based such as those from the Public Health England Behaviour Change Guide: Adult weight management: changing behaviour techniques – GOV.UK (www.gov.uk)

The Provider must ensure that family, carer and/or household support is accommodated where this would be preferred by a Service User. The Provider should facilitate peer support for service users who have a preference for this.

The Provider must ensure that a multi-disciplinary team of health professionals or specialists relevant to the core components of the Service (i.e. Type 2 diabetes, behaviour change, weight loss, diet) is involved in development of the Service. These should include, as a minimum; a registered dietitian and registered health professional with specialist diabetes knowledge.

3.2.11 Training and competencies for the service

The Provider will ensure that the Service is delivered by suitably trained and competent individuals who are trained in delivery of behaviour change. The Provider will specify the type and level of qualification, training and / or competence to be expected. The Provider needs to demonstrate that these qualifications will ensure that front-line Staff are trained to deliver interventions in line with NICE PH49 (as set out in section 4.1) for overall behaviour change.

The Provider must ensure that all individuals involved in the delivery of the Service have sufficient and appropriate training and competencies required to deliver the actions and content of the Service, recognise individual needs and provide appropriate support including advice, techniques and signposting to other services. The Provider must manage confidential and sensitive personal identifiable data. This must include training in delivery of the Service. Training must be routinely monitored and updated as necessary, and suitable continued professional development strategies must be in place.

The Provider will ensure that all Staff adopt a person-centred, empathy-building approach in delivering the Service. This includes finding ways to help service users make changes by understanding their beliefs, needs and preferences and building their confidence.

The Provider must ensure that the Service is delivered in a way which is culturally sensitive to local populations, and flexible enough to meet the needs of service users with diverse needs. This includes adaptation of dietary advice and plans to the Service User’s preferences and culinary traditions. Where reasonable and appropriate, the Provider will provide Services in languages to suit the needs of the local population.

Ideally staff delivering the Service will reflect the diversity of the population accessing the Service.

3.2.12 Clinical training and competencies for the service

There is not a requirement for health professionals to deliver content of sessions (or, in the Digital Delivery Model, episodes of engagement), nor be involved in sessions (or, in the Digital Delivery Model, episodes of engagement). In discussions about physical activity taking place during the Weight Maintenance Phase, it would be beneficial to involve a qualified physical activity instructor trained in behaviour change in the design of the Service.

All Staff required to undertake weight, blood pressure and finger-prick blood testing must be appropriately trained to do so.

All Staff delivering the Service must be trained to appropriately recognise adverse events, including those relating to blood pressure or blood glucose levels, and safely respond where able and appropriate to do. Those delivering the intervention are required to promptly seek advice from the Provider’s appointed Medical Director. This will include a requirement to appropriately interpret results and feedback to GP Practices if there is concern.

The Provider must have a Medical Director, who is available at all times, relevant to the delivery of the Service, to advise Staff and provide guidance on appropriate courses of action particularly in the case of an adverse event. The Medical Director must be a registered medical practitioner within the meaning of Schedule 1 of the Interpretation Act 1978 and must have an MRCP or MRCGP.

It is the role of the Provider’s Medical Director in relation to adverse events, to:

• Respond appropriately to all adverse events;
• Respond and give advice about non-serious adverse events and side effects; and
• Appropriately record all adverse events, liaise with the relevant service users’ GP practices as appropriate, and notify the Commissioner within the next regular monthly report of adverse events and side effects (unless the Provider’s Medical Director considers the individual circumstances of the event necessitate earlier reporting).

Staff must also have undergone information governance training and have confidentiality clauses in their contracts of employment.

The Provider acknowledges and agrees that the Service involves training, teaching, instruction, assistance, advice and guidance provided wholly or mainly for adults receiving healthcare. The Commissioner therefore considers the Service to be regulated activity for the purposes of regulations governing the use of Enhanced DBS & Barred List Checks and the Provider must carry out Enhanced DBS & Barred List Checks in respect of all members of Staff engaged in the Service who are eligible for such checks and must not engage any such person in the Service who is barred from working with vulnerable adults or is otherwise unsuitable for working with vulnerable adults. The Provider must ensure that any Sub-contractor is subject to similar obligations.

3.2.13 Weight loss

It is anticipated that the majority of the weight loss will be attained during the TDR Phase.

The Provider must, following the TDR Phase or any further period of TDR, i.e. rescue packages, work with Service users to assess their dietary intake and support planning of sustainable dietary changes, to achieve a healthy balanced diet as set out in the current national guidance. If the BMI of the Service User has decreased below 21 kg/m2 in people from White ethnic groups or below 19 kg/m2 in people from Black, Asian and other ethnic groups as set out in section 3.2.6 under the heading “TDR Phase” above, the Provider must not support further weight loss.

Following the TDR Phase or any further period of TDR, i.e. rescue packages, the Provider must design approaches to support service users to maintain a healthier weight in line with NICE Guideline NG7.

3.2.14 Dietary content

Following the TDR Phase or any further period of TDR, i.e. rescue packages, the design and delivery of the curriculum must be underpinned by the UK Government dietary recommendations, acknowledging the findings of the Scientific Advisory Committee on Nutrition consultation (May 2021). The current recommendations are detailed in the Eat Well Guide. The Eat Well Guide shows the proportions of the main food groups that form a healthy balanced diet.  It promotes a diet high in fibre, fruit and vegetables and low in saturated fat, sugar and salt. 

The Provider must support service users to achieve the Government’s dietary recommendations, using dietary approaches that are evidence based and sustainable in the longer term.

The Commissioner may vary the requirements in this section 3.2.14 if there is a change in the national guidelines. For the avoidance of doubt, the Provider’s consent is not required for such variations and General Condition 13 does not apply to such variations.

Service users should be supported to set individualised weight maintenance goals following the TDR Phase which may include setting tailored achievable short, medium and long term dietary and physical activity goals which help them to achieve their aims.

Dietary advice should reflect the culinary traditions of the populations in which the Service is being provided wherever possible (information on the populations is set out in the Local Service Requirements in Appendix 2 of this Schedule 2A).

3.2.15 Physical activity content

During the TDR Phase it is not recommended that additional physical activity is actively encouraged. However, following TDR, the Provider will support service users to undertake regular physical activity and aim to minimise or break-up extended periods of being sedentary, ultimately working towards achieving the UK Chief Medical Officer’s physical activity recommendations: UK Chief Medical Officers’ physical activity guidelines communications framework – GOV.UK

The Provider will tailor the support provided as part of the Service to meet the needs, goals and capabilities of individual service users and care should be taken to set achievable goals in being active.

The Provider may incorporate into the Service, methods for self-monitoring to enable the Service User to capture individual-level change in weight, diet and physical activity. Methods may include the provision of, or integration with, wearable devices once the TDR Phase is complete.

The Provider must ensure that content of the Service is regularly reviewed and adjusted to stay up to date with government recommendations and new evidence.

3.2.16 Final session/episode of engagement

The “Final Session” (or, in the Digital Delivery Model, the “Final Episode of Engagement”) is defined as the last session or episode of engagement delivered by the Provider as part of the planned Service (for those service users still attending or participating).

As part of the Final Session or Final Episode of Engagement, the Provider must conduct a post intervention assessment of weight, wellbeing, and achievement of individual goals for all service users who attend or participate. Arrangements for collection of Service User feedback / customer satisfaction survey should be agreed. Details of the data to be reported are provided in Schedule 6A.

The Provider must again ensure that links are made with local or national activities and services, in order to provide support for service users to continue with improvements made to dietary and physical activity behaviours and body weight.

The Provider must ensure that service users are reminded about key sources of information and advice, such as the NHS website.

The Provider should make available support and advice post intervention to service users to encourage the maintenance of improved lifestyles.

3.2.17 Service user measurements

Blood pressure

For service users who are prescribed medication which may lower blood pressure at the time of referral, blood pressure must be monitored by the Provider as follows;

• Blood pressure monitoring should be undertaken at every session (or, in the digital delivery model, episode of engagement) with the provider.
• Where the face-to-face delivery model is being delivered and a session is occurring face-to-face in-person, all required readings will be taken by the provider at that face-to-face in-person session. If a session is being delivered through other mechanisms, all required readings may be obtained remotely e.g. through self-measurement
• For the digital delivery model or where the face-to-face delivery model is subject to remote delivery, readings should be taken remotely using devices provided by the provider, submitted to the Provider and reviewed as set out in this section.
• If service users go onto a rescue package the provider must ensure weekly blood pressure monitoring over the duration of the rescue package.

The thresholds for action should be applied as follows:

• 89/59 mmHg or lower (systolic and/or diastolic) or postural symptoms – the Provider must contact the Service User’s GP practice team. If symptoms are interfering with daily activities, same-day contact with the GP practice must be made (the Provider must contact the GP practice directly and the Service User must also be advised to contact their GP practice same-day);
• Between 90/60 and 159/99 mmHg – no additional action required, continue intervention;
• Between 160/100 and 179/119 mmHg (systolic and/or diastolic) over two sessions (or, in the Digital Delivery Model, two episodes of engagement) – the Provider must contact the Service User’s GP practice;
• 180/120 mmHg or higher (systolic and/or diastolic) – there must be same-day contact with the Service User’s GP practice (the Provider should contact the GP practice directly and the Service User must also be advised to contact their GP practice same-day);
• For avoidance of doubt, if a blood pressure reading could fit into two of the categories described above (such as 181/118 mmHg), action should be taken in line with the category prompting the most rapid response (in this case, same-day contact with the GP practice).

For the digital delivery model, and any sessions being delivered as part of the face-to-face delivery model but which are not being delivered in-person (whether due to service user choice or remote delivery required by the commissioner), blood pressure measurement may be arranged at venues or services nearby and convenient to service users or self-measurement may be used (with relevant equipment, training and support provided to the service user by the provider at the provider’s cost).

The provider must use a validated device for the type of testing that they propose, and ensure that their workforce has received appropriate training to use the devices as specified, providing quality measurements. Guidance on appropriate monitors can be found here BP monitors – British and Irish Hypertension Society | Registered UK Charity No. 287635 (bihsoc.org).

Weight

Weight measurements must be taken at every session.

Where the face-to-face delivery model is being delivered and a session is occurring face-to-face in-person, all required readings will be taken by the provider at that face-to-face in-person session.

For the digital delivery model, and any sessions being delivered as part of the face-to-face delivery model but which are not being delivered in-person (whether due to service user choice or remote delivery required by the commissioner), all required readings may be obtained remotely e.g. through self-measurement.

The baseline weight and height measurement should be recorded by the provider at the first session (or, in the digital delivery model, episode of engagement) of the TDR Phase.

BMI will be calculated at baseline and every time a weight measurement is taken. As set out in section 3.2.6, TDR should be stopped, with no further advice directed at weight loss, if BMI falls below 21kg/m2 in people from White ethnic groups or below 19kg/m2 in people from Black, Asian and other ethnic groups. 

Data collection of weight measurements in face-to-face in-person sessions must be taken using appropriately calibrated scales (see PHE standard evaluation framework for weight management interventions for details of measurement of height and weight: Weight management interventions: standard evaluation framework – GOV.UK (www.gov.uk)

Scales used to measure weight where face-to-face delivery models are being used should meet Class III scales for levels of accuracy as per UK weighing federation guidance): Guidance Notes – UKWF

For the digital delivery model, and where a session is being delivered as part of the face-to-face delivery model but which is not being delivered in-person (whether due to service user choice or remote delivery required by the commissioner), the provider will provide at its own cost scales to each service user and home scale readings must be shared by service users with the provider. Measurements must be taken at all sessions (or, in the digital delivery model, episodes of engagement) as specified in this service specification, on the same device consistently (as appropriate). For all devices provided to service users by the provider, the provider must ensure that the device adheres to the error margins for Class IV scales (set out in Table 1 of the UKWF Guidance). The commissioner acknowledges there may be limited options on the market for certified Class IV scales (particularly digital scales that are certified Class IV in the UK), so confirmation from the manufacturer that the scales adhere to the error margins for Class IV scales (set out in Table 1 of the UKWF Guidance) is acceptable, in place of the official certification.

If service users go on a rescue package at any stage during the Service, the Provider must ensure weekly weight measurement recording and reporting for the duration of the rescue package.

Blood glucose testing

For all service users, finger prick capillary blood glucose testing should be monitored by the provider as follows;

• Finger prick capillary blood glucose testing should be undertaken at every session with the provider;
• Where the face-to-face delivery model is being used and a session is occurring face-to-face in-person, all required readings will be taken by the Provider at the relevant session. For the digital delivery model, and where a session is being delivered as part of the face-to-face delivery model but which is not being delivered in-person (whether due to service user choice or remote delivery required by the commissioner), all required readings will be submitted by the service user to the Provider and reviewed as set out in this section;
• If service users go onto a rescue package the Provider must ensure weekly blood glucose monitoring over the duration of the rescue package.

The thresholds for action should be applied as follows:

• Under 15 mmol/l – no additional action required, continue intervention;
• Between 15.0 – 19.9 mmol/l over 2 Sessions – the Provider must contact the Service User’s GP practice;
• 0 mmol/l or higher – there must be same-day contact with the service user’s GP practice team (the Provider must contact the GP practice directly and the service user must also be advised to contact their GP practice same-day).

Finger prick blood glucose testing may be arranged at venues or services

Finger prick blood glucose testing may be arranged at venues or services nearby and convenient to service users or self-measurement may be used for the digital delivery model, and where a session is being delivered as part of the face-to-face delivery model but which is not being delivered face-to-face in-person (whether due to service user choice or remote delivery required by the commissioner), with relevant equipment, training and support provided to the service user by the provider at the provider’s cost.

When selecting blood glucose meters the provider should ensure that the selected meter meets current International Organization for Standardization (ISO) standards for blood glucose meters (ISO15197) and that choice is aligned with locally agreed provision of blood glucose meters on the NHS.

The CQC’s guidance on the diagnostic and screening procedure regulated activity confirms that non-ambulatory blood pressure monitoring and blood tests carried out by means of a pin prick test are excluded from the registration requirements for this regulated activity. However, the provider must satisfy itself as to whether CQC registration is required for any action that it undertakes.

3.2.18 Discharge from the service

The service user is “discharged” from the service in the following circumstances:

• If, after the provider contacts an individual following referral, the individual does not respond to the Provider after one calendar month from referral provided that the Provider has made a minimum of three attempts to contact the individual, and used various communications channels as set out in section 3.2.4 above;
• If, after the provider contacts an individual following referral, the individual indicates that they do not accept the service;
• If, after the provider contacts an individual following referral, the individual indicates that they accept the service, and do not complete an Individual assessment within 90 days of referral;
• If, after the service user has accepted the service but fails to attend or participate in a scheduled and agreed individual assessment, an individual assessment has not been completed within one calendar month of the date the service user failed to attend or participate in the scheduled and agreed individual assessment;
• If, following an individual assessment the individual:
  • does not attend or participate in a first session (or, in the digital delivery model, episode of engagement) where the Provider has offered the session (or, in the digital delivery model, episode of engagement) on three separate occasions at times (and for the face-to-face delivery model, venues) suitable to the individual; or
  • does not attend the first session (or, in the digital delivery model, episode of engagement) within 90 days of the individual assessment;
• If, during the TDR Phase, it is established that the service user is not complying, or unable to comply, with the requirements of the service;
• If, whilst participating in the service, an adverse or concurrent event occurs of sufficient severity that it would no longer be appropriate for the service user to continue on the service;
• If a Service User becomes pregnant whilst participating in the service, the service user should be discharged from the service to the care of her GP practice. It must be made clear to pregnant women that weight loss or dieting during pregnancy is not advised;
• When a service user informs the provider they no longer wish to participate in the service;
• If, during the first 2 weeks of the TDR Phase, it is established that a service user cannot tolerate the TDR products;
• If, during the first four weeks of the TDR Phase, a Service User misses a session (or, in the digital delivery model, episode of engagement) (or there is no recorded engagement for one week) without prior notification to the provider and the service user does not make contact within one week; or the service user is not successfully contacted by the provider within one week and the Provider has made a minimum of three attempts to contact the service user using at least two of the following means of communication: letter, phone call, text message or email;
• If, during the TDR Phase after the first four weeks or during a rescue package, a service user misses a session (or, in the digital delivery model, episode of engagement) (or there is no recorded engagement for two weeks) without prior notification to the provider and the service user does not make contact within two weeks, or is not successfully contacted by the provider within two weeks following a minimum of three attempts to contact the service user using at least two of the following means of communication: letter, phone call, text message or email;
• If, after planned pause agreed in accordance with section 3.2.6, a service user does not re-start the programme within 4 weeks of commencing the pause;
• If, during the Food Reintroduction and Weight Maintenance Phases, if a service user misses a session (or, in the digital delivery model, episode of engagement) (or there is no recorded engagement for four weeks) without prior notification to the provider and the service user does not make contact within four weeks, or is not successfully contacted by the provider within four weeks following a minimum of three attempts to contact the service user using at least two of the following means of communication: letter, phone call, text message or email;
• If a service user does not submit measurements of the same type (weight, blood glucose, or blood pressure if applicable) at two consecutive sessions set out in section 3.2.17 where the service user is required to submit them and the provider has made a minimum of three attempts to contact the service user to obtain each such measurement using at least two of the following means of communication: letter, phone call, text message or email;
• On completion of the final session or final episode of engagement (or once the final session or final episode of engagement has been delivered). Once the final session or final episode of engagement is completed then the service user is discharged automatically regardless of the number (or percentage) of sessions attended or episodes of engagement participated in.

The provider must notify the service user’s GP practice that the service user has been discharged. The length of time the service user participated, the stage of the intervention reached, and the initial and most recent weight measurements should be communicated, as well as the reason for discharge. If the service user has been discharged during the TDR Phase and any medication changes were made on the first day of TDR, the GP practice must be asked to arrange review to consider restarting medication using the template letters provided by the Commissioner.

Where an individual has previously started TDR and has subsequently been discharged from the programme for any reason, the provider will not accept a re-referral of that individual until at least 12 months have elapsed since the date they were previously discharged.

Discharge requirements

If a Service User had started the TDR phase but is discharged before the TDR phase is completed, the Provider must provide the service user and the GP practice with a letter of discharge in accordance with the template letters provided by the commissioner. Unless otherwise specified in these template letters, if any medication were stopped on the first day of TDR, the letter should advise the service user to make contact with their GP practice within two operational days to arrange a review to discuss the potential need to restart medication (determination of the required urgency of such a review will be up to the GP practice), or if no medications were stopped on the first day of TDR, the letter should advise the service user to make contact with their GP practice within 4 weeks for a routine review. Similarly, the letter of discharge to the GP practice must reflect this advice.

Unless otherwise specified in the template letters, if discharge occurs once the TDR Phase has been completed, the letter of discharge must advise the service user to make contact with their GP practice within 4 weeks for consideration of a repeat blood tests and a routine review. Similarly, the letter of discharge to the GP practice must advise the GP practice to consider repeat blood tests and a routine review.

The provider must comply with any template letters or discharge communication content that the commissioner notifies the provider must be used.

The Provider must comply with relevant clinical codes associated with data items and include clinical codes in all notifications as specified by the commissioner under the contract.

3.2.19 Links to other services

The provider must ensure that links are made with existing local networks and partnerships throughout the development and delivery of the service. This could include, for example, leisure and public health services, departments within local authorities, the NHS website, and local “exercise on referral” schemes.

3.3 Marketing of the service

The provider must undertake marketing and promotional activity in conjunction with the local health system to advertise the existence of the service, with a view to raising awareness of the eligibility criteria and the availability and benefits of the service amongst local GP practices and to people in the geographical area covered by the contract and eligible for the service who may benefit from participating in the NHS T2DR Programme.  Any marketing or promotional activity must be designed to target groups in the community which are currently less likely to access services and encourage them to find out more about and attend or participate in the service.  

In marketing the service, the provider must conform to any guidelines on social marketing of the service under the contract, for example to ensure alignment of messaging with any wider social marketing campaigns being undertaken in relation to diabetes, or health promotion more generally. This includes using any branding guidelines developed by the commissioner specifically for this service.

Providers must not use personal information provided to them by GP practices to target individuals directly.

3.4 Intellectual property

For the avoidance of doubt, notwithstanding general condition 1.2, the parties expressly agree that this section 3.4 shall take precedence over general condition 22 in respect of intellectual property. 

Except as set out expressly in this contract, no party will acquire the intellectual property rights (IPR) of the other party.

The provider grants the commissioner a fully paid-up non-exclusive licence to use provider IPR for the purposes of the exercise of its functions and obtaining the full benefit of the services under this contract, which will include the dissemination of best practice to commissioners and providers of health and social care services.

The commissioner grants the provider a fully paid-up non-exclusive licence to use commissioner IPR under this contract for the sole purpose of providing the services.

In the event that the provider or the commissioner at any time devise, discover or acquire rights in any Improvement it or they must promptly notify the owner of the IPR to which that Improvement relates giving full details of the Improvement and whatever information and explanations as that party may reasonably require to be able to use the Improvement effectively and must assign to that party all rights and title in any such Improvement without charge.

Any IPR created by the commissioner in the exercise of its licence rights under this contract will be owned by the Commissioner.

The provider must disclose all documents and information concerning the development of best practice IPR to the commissioner at review meetings and must grant the commissioner a fully paid-up, non-exclusive perpetual licence to use best practice IPR for the purpose of the exercise of its functions together with the right to grant sub-licences to Public Health England and any participating commissioner for the purpose of the exercise of their respective functions.

“Best practice IPR” in this section 3.4 means any IPR developed by the provider including improvements to such IPR in connection with or as a result of the services.

“Improvement” in this section 3.4 means any improvement, enhancement or modification to commissioner IPR, provider IPR or best practice IPR (as the case may be) which cannot be used independently of such IPR.

“IPR” in this section 3.4 means inventions, copyright, patents, database right, domain names, trade marks, module names, rights in computer software, database rights, rights in get-up, goodwill and the right to sue for passing off, designs and confidential know-how and any similar rights anywhere in the world whether registered or not, including applications and the right to apply for any such rights.

“Participating commissioner” in this section 3.4 means a clinical commissioning group or local authority in relation to whose geographical area the Services are delivered.

“Provider IPR” in this section 3.4 means any IPR owned by or licensed to the provider (other than by the commissioner) that will be used by the provider in the delivery of the services (as set out in appendix 3 of this schedule 2A), including Improvements to such IPR.

The provider shall ensure and procure that the availability, provision and use of the service and the performance of the Provider’s responsibilities and obligations hereunder shall not infringe any intellectual property rights of any third party.

The provider shall during and after the contract term indemnify the commissioner against all Losses incurred by, awarded against or agreed to be paid by the commissioner (whether before or after the making of the demand pursuant to the indemnity hereunder) arising from an IPR claim. An IPR claim is defined as any claim of infringement or alleged or threatened infringement by a third party (including the defence of such infringement or alleged or threatened infringement) of any IPR, used to provide the Services or as otherwise provided and/or licensed by the provider (or to which the provider has provided access) to the Commissioner in the fulfilment of its obligations under this contract.

If an IPR claim is made, or the provider anticipates that an IPR claim might be made, the pProvider may, at its own expense and sole option, either:

• procure for the commissioner the right to continue using the relevant IPR which is subject to the IPR claim; or
• replace or modify the relevant deliverable with non-infringing substitutes provided that:
  • the performance and functionality of the replaced or modified deliverable is at least equivalent to the performance and functionality of the original deliverable; and
  • there is no additional cost to the commissioner.

If the provider elects to procure a licence or to modify or replace a deliverable pursuant to the provision above but this has not avoided or resolved the IPR claim, then:

• the commissioner may terminate this contract by written notice with immediate effect; and
• without prejudice to the indemnity set out above, the provider shall be liable for all reasonable and unavoidable costs of the substitute deliverables and/or services including the additional costs of procuring, implementing and maintaining the substitute deliverables.

3.5 Cyber essentials

The provider has and will maintain certification under the HM Government Cyber Essentials Scheme (basic level) until such time as the provider obtains cyber essentials plus certification in accordance with the provision below.

The provider shall, as soon as is reasonably practicable after the services commencement date, obtain certification under the HM Government Cyber Essentials Scheme to the level of cyber essentials plus and maintain such certification for the contract term.

3.6 Digital technology assessment criteria

The provider must ensure that the service, when provided via the digital delivery model complies with the requirements of the Digital Technology Assessment Criteria (“DTAC”) and ensure that the service is updated if requirements of the DTAC are updated.

3.7 Government digital service technology code of practice

The provider must ensure that the service adheres to the requirements of the Government Digital Service Technology Code of Practice, which is currently available at: The Technology Code of Practice – GOV.UK (www.gov.uk)

3.8 Identity verification and authentication standard for digital health and care services

If the provider’s digital service is by its nature a service to which NHS Digital’s “Identity verification and authentication standard for digital health and care services” applies, then the provider is required to ensure it adheres to this standard. Please refer to the standard for applicability: DCB3051 Identity Verification and Authentication Standard for Digital Health and Care Services – NHS Digital.

The provider agrees to provide evidence of adherence to the standard to the commissioner on request.

3.9 Information governance

The provider will submit the “data output specification” document in schedule 6A to the commissioning support service specified by the commissioner and in the manner specified by the commissioner.

The provider will invite all individuals they have contacted following referral and all service users to agree be contacted for the purpose of service evaluation and record their consent where given. The commissioner will specify this proportion of service users and also the timing and manner of the invitation. 

The provider will respect any request by a service user not to disclose information that identifies them in the documents indicated above.

For the avoidance of doubt, the requirements above are in addition to the information governance requirements set out elsewhere in this contract.

3.10 Additional service delivery requirements

The provider must:

• provide the service in the following geographical area – [added in final contract]
• ensure that the number of service users who achieve milestone 1 (as defined in schedule 3C) does not exceed [added in final contract] during the contract term. This number is the “intervention cap” for the purposes of schedule 3C;
• work with the local health system to agree and implement a strategy for managing demand within the Intervention Cap;
• ensure that no service user is invited to participate in the service after a period of two years has elapsed since the effective date. This period is the “intervention period” for the purposes of schedule 3C;
• actively monitor and report to the commissioner and local health systems, the number of service users who achieve milestone 1 on the service throughout the contract term; and
• notify the commissioner as soon as reasonably practicable where the number of service users achieving milestone 1 (as defined in schedule 3C) is predicted to exceed the intervention Ccap.

The Commissioner may at its discretion either:

• vary the intervention cap and/or the intervention period; and/or
• notify the provider that it will not vary the intervention cap and/or the intervention period.

Where the Commissioner varies the Intervention Cap and/or Intervention Period it will notify the Provider and the Provider shall comply with the variation.

For the avoidance of doubt:

• the Provider’s consent is not required for such variations and General Condition 13 does not apply to such variations; and
• varying the figures for the purpose of this section 3.10 includes increasing or decreasing the relevant figure.

The Provider will not be paid for the Service provided to any additional service users:

• invited to participate in the Service once the Intervention Cap has been reached in accordance with paragraph 2 of Part 1 of Schedule 3C; and/or
• invited to participate in the Service once the Intervention Period has expired in accordance with paragraph 2 of Part 1 of Schedule 3C.

The Contract Term will be the period from the Effective Date to the day after which the Provider submits the data submission for the last Service User being provided with the Service who completed the Final Session or Final Episode of Engagement or other such day as agreed in writing between the Parties.

3.11 Transition

Prior to expiry or termination of this Contract, a new provider may be preparing to deliver similar services under a contract that the Commissioner has newly put in place.  In such a situation, there will be a period during which the Provider is winding down its delivery of the Service under this Contract (i.e. it will not be accepting any new referrals to its service) and a new provider is commencing delivery of their service.

This period is referred to as a “Transition Period”. This section 3.11 sets out obligations on the Provider who is winding down its delivery of the Service. During a Transition Period the Provider will comply with the relevant obligations set out below.

The aim during the Transition Period is that:

• General Practice engagement is maintained and a steady flow of referrals continues;
• A high quality of service is provided to service users regardless of which provider’s service they are referred to, or enrolled on; and
• There is an orderly wind down by the provider and a smooth mobilisation and commencement of delivery of the service by the incoming provider.

Subject to the other requirements of this section 3.11, the Provider is responsible for delivering the Service to all service users who have been invited to participate as defined in this Contract, within the Intervention Cap and the Intervention period specified in this Contract.  The provider must maintain high levels of engagement with service users throughout the transition period, and ensure that there is a sustainable workforce and delivery model to manage the transition period.

During the transition period, there will likely be individuals who have been referred to the provider but who have not yet been invited to participate prior to the Intervention period expiring. Such individuals will be transferred, in compliance with data protection legislation, by the provider to the incoming provider. Individuals who have not achieved (or who are unlikely to achieve, in the opinion of the provider) milestone 1 by the 2 month anniversary of the expiry of the Intervention period will also be transferred by the provider to the incoming provider unless those individuals will achieve milestone 1 on the next submission of the data output specification to the commissioner following the 2 month anniversary.

The provider is responsible for complying with relevant data protection legislation and the duty of confidentiality throughout the transfer process.

The provider shall provide to the incoming provider details on waiting lists of individuals and current session delivery locations to support sustainability of service delivery and the provider is required to attend joint planning meetings with the incoming provider throughout the transition period to support operational delivery. The provider will continue to provide data to the local health system and will provide an operational point of contact until all service users being provided with the service have either completed participation in the service or have been discharged.

3.12 Review meetings

Review meetings between the provider and the commissioner in accordance with General Condition 8 of this contract shall be conducted on behalf of the commissioner by any person nominated by the commissioner to act on its behalf. References to the “commissioner” in the context of review meetings shall be construed accordingly.

The provider will attend monthly meetings (whether in person or remotely) with the commissioner Representative to discuss progress of the delivery of the services and any key issues arising. The matters to be discussed at such meetings shall be as agreed between the provider and the commissioner representative. Such meetings shall be held in addition to review meetings (which shall be held on a quarterly basis). The provider will agree a written record of the key outputs from such meetings with the commissioner representative and provide a copy of such record to the commissioner representative within one month of the relevant meeting.

Unless agreed otherwise by the parties, at least one week in advance of these meetings the provider will deliver to the commissioner the performance reports detailed in schedule 6A, in the format described.

The provider will attend monthly meetings (as a minimum; whether in person or remotely) with local lead partner organisations, in whose areas the services are delivered, to review progress and address any specific local issues relating to the delivery of the services. These may include the rate of referrals to the services, uptake rates, issues with the referral process or service delivery, and equity of access, uptake, retention and outcomes (particularly in relation to inequity by ethnicity and socioeconomic deprivation), and any other matters as either the provider or the relevant local partner organisations considers relevant to the services. Appropriate analysis and reporting of performance relating to the programme in the local health system should be made available, with particular focus on exploring and addressing inequalities. The provider will agree a written record of the key outputs from such meetings with the local partner organisations and provide a copy of such record to the commissioner representative within one month of the relevant meeting. Such meeting records will be reviewed at review meetings between the provider and the commissioner.

At least one week in advance of these meetings, the provider will deliver to the local lead partner, the data and performance reports detailed in Schedule 6A, in the format described.

3.13 Evaluation and quality assurance

The provider will participate fully in any quality assurance processes defined by the Commissioner and co-operate in undertaking ad-hoc audits and reviews as requested by commissioners in a timely manner. This will include the submission to commissioners of:

• Agreed data and reports from external quality assurance schemes
• Self-assessment questionnaires / tools and associated evidence.

The provider will also participate in evaluations of the service commissioned by or approved by the Commissioner.

The provider must ensure that a process is in place to obtain service user feedback, such as through use of the Family and Friends Test and a system is in place for how that feedback is considered and actioned.

4. Applicable service standards

4.1 Applicable national standards (e.g. NICE)

The provider will deliver the service in accordance with all relevant clinical guidelines and other guidance and publications published nationally, in particular:

• NICE NG 28 Type 2 Diabetes in Adults: Management (2022)
• NICE NG 7 Preventing excess weight gain (2015)
• NICE PH 42 Obesity: working with local communities (2012)
• NICE PH 6 Behaviour change: the principles for effective interventions (2007)
• NICE PH 49 Behaviour change: individual approaches (2014)
• NICE PH 44 Physical activity: brief advice in primary care (2012)
• NICE PH 41 Physical activity: walking and cycling (2013)
• NICE CG 43 Obesity: Guidance on the prevention of overweight and obesity in adults and children (2006 and updated 2015)
• NICE PH 53 Managing overweight and obesity in adults – lifestyle weight management services (2014)
• NICE PH 46 BMI: preventing ill health and premature death in black, Asian and other minority ethnic groups (2013)
• Eatwell Guide (2016)
• NICE NG 183 Behaviour change: digital and mobile health interventions (2020)

5. Applicable quality requirements

5.1 Applicable quality requirements

The quality requirements applicable to the service are set out in schedule 4.

5.2 Equity and access

In the delivery of the service the provider must comply with the obligations placed on the commissioner by section 13G of the NHS Act 2006 (due regard to the need to reduce health inequalities) and section 149 of the Equality Act 2010 as if those obligations applied directly to the provider;

The provider must promptly provide such co-operation to the commissioner as the commissioner reasonably requests regarding the commissioner’s discharge of its duties under section 13G of the NHS Act 2006 and section 149 of the Equality Act 2010; and

The provider will complete an annual Equality and Health Inequalities Impact Assessment (EHIIA) and action plan to challenge discrimination, promote equality, respect service users’ human rights and to reduce health inequalities in access to services and outcomes. The EHIIA and action plan shall be provided to the commissioner on the effective date and each anniversary of the effective date. Progress against the action plan will be reported by the provider to the commissioner on a quarterly basis at the relevant review meeting.

The provider must at all times adhere to all relevant health and safety and security law in providing the services.

Publication reference: PRN00758