NCT03214471

Evaluation of a Lifestyle Intervention After Bariatric Surgery

Evaluation of the Effect of a Lifestyle Intervention Compared to Usual Care on Weight Loss and Changes in Body Composition, Physical Activity Levels and Health-related Quality of Life in the First Year Following Bariatric Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to evaluate the effect of a post-surgery 12-month lifestyle intervention compared to usual care upon post-surgery weight loss and changes that occur in body composition (relative amounts of body fat, muscle and bone), physical fitness and activity levels, diseases linked to obesity (e.g. diabetes, high blood pressure, high cholesterol level, sleep apnoea) and health-related quality of life (HRQoL) over a 12-month period.

Detailed description

People with severe obesity who are scheduled to undergo either primary gastric bypass or primary sleeve gastrectomy will be recruited from the Bariatric Clinics at University College London Hospital (UCLH) and the Whittington Hospital and asked to participate in an observational cohort study. Eligible patients will be given a participant information sheet (PIS) for BARI-LIFESTYLE Observational Study and informed consent will be sought. Recruited patient will attend for 4 research visits, timed to coincide with their clinic visits, at approximately 6 weeks before surgery (Visit 1), 3 month post-surgery (Visit 2), 6 months post-surgery (Visit 3) and 12 months post-surgery (Visit 4). Each research visit will include assessment of body weight, body composition (using bioelectrical impedance analysis), physical fitness and activity levels, obesity-associated co-morbidities, HRQoL and usual care laboratory investigations. Dual energy X-ray absorptiometry (DXA) scanning will be undertaken at Visit 1 and Visit 4, which is not a usual assessment for the post-surgery standard care. All of the research assessments will be done as part of this observational cohort study. Immediately after surgery has been undertaken, BARI-LIFESTYLE Observational Study participants will be randomised to continue to receive usual care, or usual care plus lifestyle intervention (nutritional and behavioural tele-counselling, self-monitoring and a 12-week supervised tailored exercise programme). However, to avoid contamination between the intervention group and the usual care group, only those randomly allocated to the lifestyle intervention group will be informed of this. They will be given a PIS (BARI-LIFESTYLE Intervention Study) and informed consent will be sought. If the participants decline to take part in the lifestyle programme, they will remain in the control group (observational cohort study).

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle intervention	Nutritional and behavioural tele-counselling , self-monitoring and a 12-week supervised tailored exercise programme. Participants will receive a regular tele-counselling throughout the 12-month. Each session will take approximately 15 minutes, underpinned by behavioural psychological techniques. After their 3-month post-surgery assessment visit, participants in the BARI-LIFESTYLE Intervention Study will be enrolled in a supervised exercise programme at health facility gyms for 12 weeks.

Timeline

• Start date: 2018-02-20
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2017-07-11
• Last updated: 2021-04-27

Locations

1 site across 1 country: United Kingdom