A group-based programme for weight management (PROGROUP) versus usual care for weight management in adults with severe obesity

INTERVENTION: Patients who have been identified as potentially eligible for the study and who are about to have their first appointment at the NHS weight management service, or have recently had an initial appointment, will be provided with information about the study by the NHS staff. There are a couple of different points that the patient will be offered introductory information about the study. In all cases, patients will receive a short Study Summary Leaflet and a Participant Information Sheet (PIS), and a member of NHS staff will ask the patient if they are willing to be contacted about the study directly by a member of the PROGROUP research team. All patients approached will have the opportunity to discuss the study with a member of staff at the service or a member of the PROGROUP research team. Consent: Patients will be given at least 24 h to consider the PIS before being contacted by a member of the PROGROUP research team (only if the patient has given permission for direct contact). The researcher will review eligibility criteria with the participant and explain the study in further detail, addressing any queries raised by the patient, based on their reading of the PIS. If the patient is still willing to participate, informed consent will be taken, ether during the course of the telephone call, or may be rescheduled for a further call if preferred. Randomisation: Because the PROGROUP intervention is group‐based, a sufficient number of participants are needed at each site to run the group. Recruitment will continue at the site until a cohort of sufficient size is reached. Only then will participants be randomised to PROGROUP (intervention) or usual care (control), but participants can expect to CONDITION: Severe obesity ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: ; 1. Recruitment rate is recorded as number of patients screened, consented (as a proportion of patients screened), and randomised (as a proportion of patients screened) at the time of screening and the time of randomisation; 2. Retention rates are recorded as the number of recruited patients attending follow up visits at 6 and 12 months; 3. Batch randomisation rate is measured as the time required to recruit enough participants within a site to trigger randomisation for a cohort at the time of randomisation; 4. Data completeness for outcome measures and acceptability of outcome measures measured by recording number of completed self‐report questionnaires and the number of missing items within a questionnaire at baseline, 3, 6, and 12 months; 5. Acceptability of planned approach for longer‐term follow‐up measured using consent rates for additional follow‐up data at 5 months; 6. Fidelity of PROGROUP training and delivery assessed by fidelity assessment and iteratively refine delivery based on these assessments; 7. Acceptability of trial processes and the intervention to the participants measured using intervention attendance rates and intervention engagement at baseline, 1‐2, 3, 4, 5, 6, 7, 8, 9, 10, 11‐12, 14, 16, 18, 20, and 21‐22 weeks; 8. Adherence to usual care measured by Tier 3 appointment attendances between baseline and 22 weeks; SECONDARY OUTCOME: ; 1. Weight loss measured using weight at baseline, 6, and 12 months post‐randomisation.; 2. Percentage of participants achieving =5% weight loss measured using weight at baseline, 6, and 12 months post‐randomisation; 3. Percentage of participants achieving =10% weight loss measured using weight at baseline, 6, and 12 months post‐randomisation; 4. BMI derived from height at baseline and weight at baseline, 6, and 12 months post‐randomisation; 5. Diabetes risk/diagnosis of diabetes/control of diabetes measured using HbA1c at baseline, 6, and 12 months post‐randomisation; 6. Cardiovascular disease risk calculation measured using:; 6.1. Blood Pressure at baseline, 6, and 12 months post‐randomisation; 6.2. Lipid profile measured using Total Cholesterol, HDL Cholesterol, and Triglyceride at baseline, 6, and 12 months post‐randomisation; 7. Change in alcohol use (non‐validated) at baseline, 6, and 12 months post‐randomisation; 8. Change in Adult Eating Behaviour Questionnaire at baseline, 6, and 12 months post‐randomisation; 9. Change in International Physical Activity Questionnaire (IPAQ) short form at baseline, 6, and 12 months post‐randomisation; 10. Change in EQ‐5D‐5L questionnaire at baseline, 6, and 12 months post‐randomisation; 11. Change in ICECAP‐A questionnaire at baseline, 6, and 12 months post‐randomisation; 12. Change in PHQ‐4 questionnaire at 6 and 12 months post‐randomisation.; 13. Change in self‐esteem and life satisfaction (non‐validated) at baseline, 6, and 12 months post‐randomisation; 14. Change in health and social care resource use questionnaire at baseline, 6, and 12 months post‐randomisation; 15. Change in recorded comorbidities at baseline, 6, and 12 months post‐randomisation; 16. Change in use of relevant medications at baseline, 6, and 12 months post‐randomisation; 17. Change in social identification (non‐validated) measure at baseline, 3, 6, and 12 months post‐randomisation; 18. Change in loneliness (non‐validated) measure at baseline, 3, 6, and 12 months post‐randomisation; INCLUSION CRITERIA: 1. Body Mass Index =40 or =35 kg/m² with comorbidity 2 Aged =18 years 3. Willing to be randomised to either PROGROUP or usual care 4. Registered with the T3WMC 5. Considered suitable for group‐based care 6. Have capacity to consent