Evaluation of a Lifestyle Intervention After Bariatric Surgery
Condition: Obesity
Study type: Interventional

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).
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: bariatric surgery; healthy lifestyle