Clinical trial NCT03214471: Evaluation of a Lifestyle Intervention After Bariatric Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: bariatric surgery
healthy lifestyle
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial will be a two-arm, parallel group, single-blinded, single site RCT (embedded within an observational cohort study) conducted in London, United Kingdom (UK). A two-staged randomised consent design will be applied (See 8.2 Randomisation procedures). Recruitment will take place at the Bariatric Centre for Weight Management and Metabolic Surgery, University College London Hospitals (UCLH) and the Bariatric and Obesity Surgery Clinic at the Whittington Hospital. The trial will be carried out by the Centre for Obesity Research, Division of Medicine, University College London (UCL) at UCLH, which will be commenced in August 2017 with the expected total duration of 36 months. The total duration of each participation in the trial is approximately 12-16 months (12 months from the day of surgery). All participants will have to attend 4 research visits; baseline visit (approximately 6 weeks before surgery), then at approximately 3, 6, and 12-month post-surgery.
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: %WL
timeFrame: 52 weeks
Secondary outcomes:
measure: body fat
timeFrame: 52 weeks
measure: bone mineral density
timeFrame: 52 weeks
measure: skeletal muscle mass
timeFrame: 52 weeks
measure: physical activity (PA) levels
timeFrame: 12, 26 and 52 weeks
measure: 150 minutes of activity
timeFrame: 12, 26 and 52 weeks
measure: sedentary time
timeFrame: 12, 26 and 52 weeks
measure: 6MWT
timeFrame: 12, 26 and 52 weeks
measure: STS
timeFrame: 12, 26 and 52 weeks
measure: Handgrip test
timeFrame: 12, 26 and 52 weeks
measure: 36-Item Short-Form Health Survey Instrument (SF-36)
timeFrame: 12, 26 and 52 weeks
measure: Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
timeFrame: 12, 26 and 52 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 12, 26 and 52 weeks
measure: Medical history
timeFrame: 12, 26 and 52 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
Study officials:
affiliation: UCL
name: Rachel L Batterham, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
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