PROGROUP 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 multi-centre, two-arm, individually randomised controlled, assessor-blinded, adaptive superiority trial with parallel process evaluation and health economic evaluation
IRAS ID
322662
Contact name
Jonathan Pinkney
Contact email
Sponsor organisation
University Hospitals Plymouth NHS Trust (UHPNT)
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Obesity affects one third of UK adults (about 15 million people). 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 it is unclear how effective these are. We designed a new programme to support people with severe obesity to manage their weight, called PROGROUP. In a small feasibility study, we found that PROGROUP was acceptable to people.
Our research question: is PROGROUP more effective and less costly than NHS usual care in supporting people with severe obesity to achieve meaningful weight loss.
PROGROUP participants are shown techniques, over a 5 month period, to help make lasting changes to their behaviour or habits when it comes to eating and physical activity. A special feature of PROGROUP is that participants meet with the facilitator together, as a group of about twelve people. There are twelve group sessions and 3 one-to-one sessions. 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. In addition, waiting lists for Tier 3 are very long; having groups allows patients to be seen more quickly than they might otherwise as individual patients.
Most adults referred to Tier 3 are eligible to take part in the PROGROUP study. Half the study participants will receive NHS Tier 3 service (usual care) and half will receive PROGROUP (intervention), at random. At the beginning, 6 and 12 months, participants will have their weight measured at the Tier 3 service, and will complete self-report questionnaires on health, social connection, and NHS use.
This project is funded by National Institute for Health Research.
REC name
West of Scotland REC 3
REC reference
23/WS/0101
Date of REC Opinion
30 Jun 2023
REC opinion
Favourable Opinion