Severe obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
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 appointm
Sponsors
University Hospitals Plymouth NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Currently engaged in any other weight management trial 2. Are scheduled to undergo bariatric surgery during the course of the trial 3. Unwilling or unable to attend group sessions 4. Intending to relocate outside the geographical region during the trial period 5. Participants who have significant difficulties in adequate understanding of English, or a sensory impairment, such that they are unable to sufficiently understand/access the trial documentation or engage in group sessions, in the absence of a local provision of translated materials or communication aids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 p | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed