Testing a new intervention for weight management called PROGROUP

Not Applicable

• Conditions: Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN13721429
• Lead Sponsor: niversity Hospitals Plymouth NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-25
• Last Update Posted: 13 November 2023
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 990

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. Registered with the T3WMC
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

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 sufficiently understand/access the trial documentation or engage in group sessions, in the absence of a local provision of translated materials or communication aids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified