The NHS is testing whether putting people with type 2 diabetes and excess weight on a low-calorie diet—delivered in person, in groups, or via an app—can work at scale, and this study will find out if it actually does. Type 2 diabetes can go into remission with rapid, substantial weight loss, but the NHS has never tried rolling out a low-calorie diet programme nationally. Previous trials were tightly controlled; this pilot runs in real clinics with real patients, many from deprived or diverse backgrounds. The researchers will track who signs up, who sticks with it, who benefits, and who drops out—and why. They will also calculate the true cost to the NHS and to patients, then model whether the programme saves money over a patient’s lifetime. If the pilot works and is cost-effective, the NHS could offer a structured low-calorie diet as a routine treatment for type 2 diabetes, potentially reducing the need for medication and long-term diabetes complications. If it fails for certain groups—for example, people on low incomes or from ethnic minorities—the findings will show exactly where the programme needs redesigning before any national rollout.
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Background: An NHS Low Calorie Diet (LCD) delivered via 1:1, group or digital support will be piloted in patients with excess weight and type 2 diabetes. Aim: To coproduce a qualitative & economic evaluation of the NHS LCD pilot, integrated with NHS data to provide an enhanced understanding of the long-term cost effectiveness, implementation, equity & transferability across broad & diverse populations. Research questions & methods: A multi-disciplinary patient-led programme of 5 work packages (WP): WP1 PROJECT MANAGEMENT, COPRODUCTION, PUBLIC AND PATIENT INVOLVEMENT (PPI) & DISSEMINATION: will 1) coordinate project management, PPI, co-production & evaluation reports: integrating WP2-5 with NHS analyses; 2) oversee dissemination: illustrative journals, infographics, website, social media, films, presentations & journal articles. WP2 SERVICE DELIVERY & FIDELITY: will use documentary review, session observations, interviews with NHS support staff & focus groups with providers, to address the following research questions (RQ): RQ1 What are the theoretical principles, behaviour change components, content & mode of delivery of the programme, & how do these vary across sites & providers? RQ2 To what extent does the staff training delivered by each provider address behaviour change theory & content, & how does this vary across sites & providers? RQ3 To what extent is the delivery of the NHS LCD delivered with fidelity to NHS specifications? RQ4 What are provider & NHS support staff experiences of the service & what do they perceive to be key barriers & facilitators to effective delivery & integration into routine care? WP3 PATIENT EXPERIENCE & INEQUITIES: will be undertaken using longitudinal patient surveys, interviews & photovoice. These findings will be integrated with NHS data to address: RQ5 To what extent is the content of the NHS LCD understood & applied by patients? RQ6 Do sociodemographic characteristics influence access, uptake, compliance & success on the NHS LCD, & does this vary across the different delivery models? RQ7 What aspects of the service work & do not work, for whom, in what context & why? RQ8 How can the service be improved in the future, to enhance patient experience, & ensure any inequities are addressed? WP4 ECONOMIC EVALUATION: will use patient-level simulation modelling to estimate long-term cost-effectiveness of the NHS LCD (cost per QALY) to inform commissioning. Micro-costing for each of the delivery models will address: RQ9 What are the costs of delivering the NHS LCD programme from an NHS perspective & how do they a) differ across the different delivery models & b) compare to estimates provided in previous trials? RQ10 What are the costs of the NHS LCD to participants & how do they differ by delivery method & socio-demographics? This & NHS data will also be used in patient-level simulation models to address RQ11: What is the long-term cost-effectiveness of the NHS LCD in terms of cost per QALY & how does this vary by delivery method & patient characteristics?. We will also replicate the methods used in previous trials to address: RQ12 How does the cost & short-term outcome data collected in this study affect the estimates of cost-effectiveness in previous trials? WP5 TRANSFERABILITY ASSESSMENT: will employ a theoretical model for the assessment of transferability to address RQ13: What are the policy implications for wide-spread adoption of the programme? Anticipated delivery timeframe & impact: Nov 20 to Oct 23. Findings will inform national roll out.
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