Recipient organisationNHS Cambridgeshire and Peterborough Integrated Care Board
Funding£2.2M
PeriodOct 2017 — Dec 2023
In plain English
AI plain-English summary
A 5-year follow-up of 1,269 people at high risk of type 2 diabetes will test whether a year-long Weight Watchers programme keeps weight off and prevents the disease, while a new trial of 575 recently diagnosed patients will see if combining the same programme with diabetes education and dietitian phone support can reduce complications. Behavioural weight management programmes work, but most are too expensive to roll out widely, and people regain weight once the programme ends. This research tackles both problems by testing programmes that use non-specialist staff and eHealth tools—making them scalable—and by developing a new maintenance programme that targets the psychological barriers to keeping weight off. If the scalable programmes prove effective and cost-effective, the NHS could adopt them nationally to prevent thousands of new diabetes cases and reduce medication needs and complications in those already diagnosed. The maintenance programme, if successful in a pilot trial, could be tested in larger studies and eventually become a standard follow-up for anyone completing a weight loss programme.
View original technical description
Rationale Behavioural weight management programmes (BWMPs) can help prevent type 2 diabetes (T2D) and reduce risk factors for complications and the need for medication in those who have T2D. However, few are sufficiently scalable and weight is typically regained when programmes end. BWMPs that use non-specialists (health trainers, community members) and eHealth are scalable. We will evaluate whether they can achieve and maintain weight loss and reduce the incidence and complications of T2D in two populations: people at high risk of T2D, and those with a recent diagnosis. Aims To quantify the impact of scalable weight loss programmes on incidence of T2D, related complications and health resource use (Work Package 1). To develop a scalable weight loss maintenance programme that specifically targets psychological determinants of weight loss maintenance, and evaluate its impact on incidence of T2D, related complications and health resource use (Work Package 2) Methods Work Package 1 To evaluate the effectiveness and cost-effectiveness of a scalable weight loss programme for individuals at high risk of T2D, we will conduct a 5-year follow up of a randomised controlled trial (RCT). Participants (N=1269; Mean BMI 34.5kg/m2) were randomised to one of three groups (brief advice, 12 weeks Weight Watchers (WW), or 52 weeks WW) and completed measurement appointments over 2 years. At 5 years, weight, HbA1c and other risk factors will be measured by CRN nurses in local practices, and data on health resource use and quality of life will be collected. To evaluate the effectiveness and cost-effectiveness of a scalable weight loss programme for individuals recently diagnosed with T2D, we will conduct a new RCT. Participants (N=575, BMI≥25kg/m2, diagnosis of T2D within 3 years) will be randomised to Live Well With Diabetes (a programme that combines 52 weeks WW with diabetes education and dietician support via telephone) or to diabetes education only. Weight, HbA1c and other risk factors will be measured at 0, 6, and 12 months by CRN nurses in local practices, and data on health resource use and quality of life will be collected. In both studies we will evaluate differences between intervention groups in primary and secondary outcomes using all available data in mixed effects models under the assumption of missing at random. We will evaluate within-trial cost-effectiveness from an NHS perspective using participant level data and imputing missing data using chained equations. We will use semi-structured interviews and focus groups, and both inductive and deductive qualitative analyses, to understand the experiences of participants and practitioners, including the acceptability of the programme and perceptions of key facilitators and barriers to weight loss maintenance. To evaluate longer term cost-effectiveness of these scalable weight loss programmes and impact on incidence of T2D and related complications, we will use the NIHR SPHR Diabetes microsimulation model. We will also use a separate microsimulation model with a non-parametric approach (NHS Health Checks model) and compare findings to reduce uncertainty in estimates and increase confidence in our findings. Work Package 2 To develop a new weight loss maintenance programme, we will draw on the MRC framework for the design of complex interventions and the Intervention Mapping Protocol. The weight loss maintenance programme will be an acceptance-based behavioural programme that targets the psychological determinants of weight loss maintenance and that can be delivered in groups by trained non-specialists using a bespoke eHealth platform. We will work with patients and practitioners to iteratively develop the programme so that it meets the needs of both. We will evaluate the feasibility and acceptability of this programme in a pilot trial. Participants (N=60; previously completed a traditional BWMP ≥3months; 50% with diabetes) will be recruited from NHS and commercial
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