Evaluation of a Lifestyle Intervention After Bariatric Surgery

University College London (UCL)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03214471

16/0232

Details and patient eligibility

About

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.

Full 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).

Enrollment: 153 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult aged between 18 to 65 years old.
2. Planned to undergo either primary gastric bypass surgery or primary sleeve gastrectomy surgery and fulfilling NICE eligibility criteria for bariatric surgery.
3. Medically safe to participate in exercise programme.
4. Able to read and write in English.
5. Willing and able to provide written informed consent.
6. Able to comply with study protocol.
7. Able to attend a supervised tailored exercise session at UCLH weekly for 12 weeks.
8. Willing and able to wear a Fitbit wrist-based activity tracker device and an Actigraph device.

Exclusion criteria

1. More than 200 kg of body weight (due to limitation of DXA Scanner).
2. Non-ambulatory.
3. Functional limitation.
4. Medical contraindication for exercise.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 2 patient groups

Usual Care

No Intervention group

Description:

usual care provided by the NHS for patients undergoing bariatric surgery.

Intervention

Experimental group

Description:

usual care + BARI-LIFESTYLE intervention

Treatment:

Behavioral: Lifestyle intervention