Weight loss maintenance in adults with overweight or obesity who have recently completed one of a range of UK-commissioned standard behavioural programmes for the prevention and treatment of obesity and type 2 diabetes. Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will be randomly allocated to one of two groups (intervention or control) in a 1:1 allocation using block randomisation (block size 6) stratified by prior weight loss programme and weight
Sponsors
University of Cambridge
Cambridgeshire and Peterborough Integrated Care Board (ICB)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: We will recruit UK adults (N=1,840) with obesity or overweight who have, in the previous 6 months, completed at least 60% of one of 5 weight loss programmes currently commissioned by the UK NHS or local authorities: 1. Tier 2 weight management programme 2. Tier 3 weight management 3. NHS Diabetes Prevention Programme 4. NHS Digital Weight Management Programme 5. NHS Diabetes Remission Programme Other inclusion criteria 1. Age =18 years 2. Capable of giving informed consent 3. Good understanding of the English language (the intervention and study materials are not tailored to support non-English language speakers) 4. Willing to be randomised 5. Willing to complete study measurements 6. Able to access the web-based platform from home
Exclusion criteria
Exclusion criteria: 1. Current use of insulin 2. Previous or planned bariatric surgery 3. Current or planned pregnancy 4. Current diagnosis of eating disorder 5. A same household partner The Study Team reserves the right to withdraw a participant at any time if they don’t follow the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight (kg) is measured using a set of weighing cellular-scales (provided to all participants by the study team) at baseline, 6 months, 12 months and 24 months. The primary outcome is change in weight from baseline to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 6 and 24-month change from baseline in weight (kg) measured using weighing cellular-scales 6, 12 and 24-month change from baseline in: 2. HbA1c measured using freepost finger prick home testing kits (provided and analysed by The Doctors Laboratory (TDL), United Kingdom, accredited to the international standard for medical laboratories, ISO15189) 3. emotional eating measured using the 21-item version of the Three-Factor Eating Questionnaire (TFEQ-R21) 4. binge eating measured using the Binge Eating Scale (BES) 5. psychological flexibility measured using the Acceptance and Action Questionnaires, Weight Related (AAQWR) 6. anxiety symptoms measured using the 7-item Generalized Anxiety Disorder scale (GAD-7) 7. depression symptoms measured using the 8-item Patient Health Questionnaire (PHQ-8) 8. stress measured using the 4-item Perceived Stress Scale (PSS-4) 9. wellbeing measured using the Short Warwick–Edinburgh Mental Well-being Scale (SWEMWBS) 10. physical activity using the International Physical Activity Questionnaire (IPAQ) - Short Form 11. diet measured using the Rapid Prime Diet Quality Score Screener (rPDQS) 12. sleep quality measured using the Brief version of the Pittsburgh Sleep Quality Index (B-PSQI) Health Economic Outcomes 13. Health-resource use measured using the Modular Resource-Use Measure (MODRUM) 14. Self-reported out-of-pocket costs and loss of productivity measured using selected modified MODRUM depth questions 15. Quality-adjusted life-years (QALYs) based on HRQoL (EQ-5D-5L) 16. Work productivity measured using the Work Productivity and Impairment Questionnaire (WPAI) (all measured at baseline, 6 months, 12 months and 24 months) | — |
Countries
England, United Kingdom
Contacts
Public ContactJenny Woolston
Outcome results
None listed