BARI-LIFESTYLE Version 1
Research type
Research Study
Full title
Evaluation of the effect of a post-surgery lifestyle intervention compared to usual care upon post-surgery weight loss and changes in body composition, physical activity levels and health-related quality of life in the first year following bariatric surgery.
IRAS ID
220368
Contact name
Rachel Batterham
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2017/04/43, UCL Data Protection Registration Number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Bariatric (weight loss) surgery helps people with severe obesity (dangerously high body fat levels) to lose weight, cures or prevents diseases linked to obesity and reduces the risk of dying. Unfortunately, 1 in 5 people does not respond well to surgery in terms of weight loss and health gains. Access to surgery is limited, and the surgery itself carries a small risk of dying. Thus, making sure that people gain the most health benefit is critical. We know that people who are more active and make the recommended eating changes after surgery lose more weight and are healthier. Currently, there are no programmes to help patients make these changes after surgery, and most patients are inactive.
The purpose of this study is to compare the changes that occur in body composition (relative amount of body fat, muscle and bone), physical activity levels, disease linked to obesity and quality of life in people receiving standard care and people receiving a lifestyle programme after surgery.
We will recruit 198 of severely obese participants, scheduled to undergo either gastric bypass or sleeve gastrectomy surgery into a one-year cohort study from UCLH and Whittington Hospital. Eligible participants will provide informed consent. Recruited participants will attend for research visits at approximately 6 weeks before surgery, then at 3, 6 and 12-month after surgery. Assessment such as body weight, physical fitness and activity, body composition (body fat, muscle, bone mass), usual blood test, health status and general well-being will be undertaken.
Immediately after surgery, participants in the cohort study will be randomly assigned to continue to receive usual care or, usual care plus lifestyle intervention (nutritional and behavioural tele-counselling, self-monitoring and a 12-week supervised exercise). To avoid 'study contamination', the usual care group will not be informed of the existence of further trial, and a second consent will be sought.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0950
Date of REC Opinion
18 Jul 2017
REC opinion
Further Information Favourable Opinion