PROGROUP Feasibility Randomised Controlled Trial v1
Research type
Research Study
Full title
A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults accessing NHS Tier 3 weight management services for treatment of severe obesity: a feasibility randomised controlled trial with parallel process evaluation and health economic evaluation
IRAS ID
302670
Contact name
Jonathan Pinkney
Contact email
Sponsor organisation
University Hospitals Plymouth NHS Trust (UHPNT)
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
Obesity affects one third of adults (about 15 million people) in the UK. Severe obesity reduces life expectancy due to potential development of diabetes, heart disease and cancer. People with severe obesity also report greatly impaired quality of life.
The NHS provides specialised weight management services for people with severe obesity, known as Tier 3 services, but what the Tier 3 clinics do, and how effective they are is unclear. Our project seeks to better understand these clinics and investigate whether a new support programme (called PROGROUP) is more effective and less costly than usual care. This project is funded by the National Institute for Health Research.
In PROGROUP, participants are shown techniques to help make lasting changes to their behaviour or habits when it comes to eating and physical activity, over a 5 month period. A special feature of PROGROUP is that participants meet with the facilitator together, as a group of about twelve people. When people develop a meaningful sense of social connection to other individuals, this can have a positive effect on behaviour change interventions in health care. There are 12 group sessions and 3 one-to-one sessions.
Before we test PROGROUP in a clinical trial, we need to test the feasibility of such a trial in a smaller number of participants, at 3 NHS sites. Most adults with severe obesity referred to the Tier 3 service are eligible to take part. Participants will be randomised to usual care (the Tier 3 service), or PROGROUP. All participants will complete questionnaires on health, lifestyle and well-being at baseline, 6 and 12 months, and weight will be also recorded at these time-points. Participants will be invited to take part in an in-depth interview about their experience of being in the trial and the acceptability of the trial processes.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0144
Date of REC Opinion
1 Nov 2021
REC opinion
Favourable Opinion