Obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current interventions for the RCT as of 16/01/2025:
Randomisation:
The cohort will be randomised in one go – half of the participants to receive the PROGROUP (intervention) and half to receive NHS T
Sponsors
University Hospitals Plymouth NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria for the RCT as of 16/01/2025: Patients must satisfy these criteria to be considered for the study: 1. Referred to the T3WMS within the last 6 months OR if referred to the T3WMS more than 6 months ago there is a clinically confirmed weight and BMI within the last 6 months. 2. In individuals with with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family background, Body Mass Index > = 37.5 kg/m2 or Body Mass Index > = 32.5 kg/m2 with at least one significant comorbidity. In all other individuals, Body Mass Index > = 40 kg/m2 or Body Mass Index > = 35 kg/m2 with at least one significant comorbidity. Patients must satisfy all of the following criteria to be enrolled in the study: 1. Registered with the T3WMC or an equivalent service 2. In individuals with with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family background, Body Mass Index > = 37.5 kg/m² or Body Mass Index > = 32.5 kg/m² with at least one significant comorbidity at the point of consent. In all other individuals, Body Mass Index > = 40 kg/m² or Body Mass Index > = 35 kg/m² with at least one significant comorbidity at the point of consent. 3.Aged > = 18 years 4. Willing to be randomised to either PROGROUP or usual care 5. Willing to be weighed on at least three occasions (baseline, 6 months and 12 months) 6. Willing to provide blood samples and blood pressure readings on three occasions (baseline, 6 months and 12 months) 7. Considered suitable for group-based care 8. Have capacity to consent Updated 29/05/2026: Inclusion criteria for the implementation study in primary care as of 18/07/2025: Patients must satisfy all of the following criteria to be enrolled in the study: • Registered with the participating GP practice/consortia. • Meet the criteria for referral to the local T3WMS. • In individuals with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family background*, Body Mass Index =37.5 kg/m2 or Body Mass Index =32.5 kg/m2 with at least one significant comorbidity** at the point of consent. In all other individuals*, Body Mass Index =40 kg/m2 or Body Mass Index =35 kg/m2 with at least one significant comorbidity** at the point of consent. • Aged =18 years. • Willing to have weight measured on at least two occasions (baseline and 6 months). • Willing to provide blood samples and blood pressure readings on two occasions (baseline and 6 months) if these are collected as part of usual care. (Where not routinely collected by sites, participants who decline to provide research bloods may still participate in PROGROUP). • Considered suitable for group-based care. • Have capacity to consent. _____ Previous inclusion criteria: Patients must satisfy these criteria to be considered for the study: 1. Referred to the T3WMS within the last 6 months OR if referred to the T3WMS more than 6 months ago there is a clinically confirmed weight and BMI within the last 6 months. 2. In individuals with with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family background, Body Mass Index > = 37.5 kg/m2 or Body Mass Index > = 32.5 kg/m2 with at least one significant comorbidity. In all other individuals, Body Mass Index > = 40 kg/m2 or Body Mass Index > = 35 kg/m2 with at least one significant comorbidity. Patients must satisfy all of the following criteria to be enrolled in the study: 1. Register
Exclusion criteria
Exclusion criteria: Current exclusion criteria for the RCT as of 16/01/2025: Patients who meet any of the following criteria will be excluded from study participation: 1. Already undergone bariatric surgery 2.Are scheduled, or have made their own plans, to undergo bariatric surgery during the course of the trial. 3. Currently taking the following pharmacotherapy for the indication of weight loss: GLP-1 analogues (e.g., semaglutide, liraglutide)*, orlistat, or any off-licence weight-reducing pharmacotherapy such as the stimulant appetite suppressants phentermine and diethylpropion. Commencing these medications from six months post-randomisation is allowable, consistent with NICE guideline 189, 1.8.1: ‘consider pharmacological treatment only after dietary, exercise and behavioural approaches have been started and evaluated’ * Taking GLP-1 analogues for diabetes control (rather than weight management) for at least 12 months prior to screening is not an exclusion criterion. 4. Currently engaged in any other weight management trial 5. Unwilling or unable to attend the Tier 3 service for intervention/UC appointments 6. Intending to relocate outside the geographical region during the trial period 7. 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. Updated 29/05/2026: Exclusion criteria for the implementation study in Primary Care as of 18/07/2025: Patients who meet any of the following criteria will be excluded from study participation: 1. Already undergone bariatric surgery. 2. Are scheduled, or have made their own plans, to undergo bariatric surgery during the course of the trial. 3. Currently engaged in any other weight management trial. 4. Unwilling or unable to attend the locations for the PROGROUP sessions and study visits. 5. Intending to relocate outside the geographical region during the trial period. 6. 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 the intervention sessions, in the absence of a local provision of translated materials or communication aids. _____ Previous exclusion criteria: Patients who meet any of the following criteria will be excluded from study participation: 1. Already undergone bariatric surgery 2.Are scheduled, or have made their own plans, to undergo bariatric surgery during the course of the trial. 3. Currently taking the following pharmacotherapy for the indication of weight loss: Semaglutide, Liraglutide, Orlistat, or any off-licence weight-reducing pharmacotherapy such as the stimulant appetite suppressants phentermine and diethylpropion. Commencing these medications from six months post-randomisation is allowable, consistent with NICE guideline 189, 1.8.1: ‘consider pharmacological treatment only after dietary, exercise and behavioural approaches have been started and evaluated’. 4. Currently engaged in any other weight management trial 5. Unwilling or unable to attend group sessions 6. Intending to relocate outside the geographical region during the trial period 7. Participants who have significant difficulties in adequate understanding of English, or a sensory impairment, such that they are unable to su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 16/01/2025: Weight (kg) at baseline and 6 months post-randomisation _____ Previous primary outcome measure: Weight (kg) at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 23/01/2025: Measured at baseline, 6 and 12 months post-randomisation (unless otherwise noted): 1. Change in weight (kg) between baseline and 12 months post-randomisation 2. Weight (kg) to calculate percentage of participants achieving =5% weight loss from baseline 3. Weight (kg) to calculate percentage of participants achieving =10% weight loss from baseline 4. BMI (kg/m²) 5. HbA1c (blood test) 6. Systolic blood pressure (mm Hg) (sphygmomanometer) 7. Total Cholesterol, HDL Cholesterol, Triglycerides (blood test) 8. Alcohol use, measured using self-reported number of alcohol units (AUDIT-C) 9. Eating behaviour, measured using Adult Eating Behaviour Questionnaire (AEBQ) 10. Physical activity measured using International Physical Activity Questionnaire (IPAQ) short form 11. Health-related quality of life measured using EQ-5D-5L questionnaire 12. Well-being measured using ICECAP-A questionnaire 13. Well-being measured using PHQ-4 questionnaire 14. Well-being measured using self-esteem and life satisfaction questionnaire 15. Well-being measured using loneliness measure at 3 months, 6 months, and 12 months post-randomisation compared to baseline 16. Health, social care and wider societal resource use measured using resource use questionnaire i.e. use of primary care and community-based services, use of hospital services, use of pharmacological interventions for weight loss, support from others e.g. family, self-funded weight loss interventions, employment status 17. Co-morbidity measured using patient records 18. Medication use measured using patient records 19. Social identification measured using social identification (non-validated) measure 20. Loneliness measured using Three-Item Loneliness Scale (non-validated) _____ Previous secondary outcome measures: Measured at baseline, 6 and 12 months post-randomisation (unless otherwise noted): 1. Weight (kg) to calculate percentage of participants achieving =5% weight loss from ba | — |
Countries
England, United Kingdom
Outcome results
None listed