Evaluation of a Lifestyle Intervention After Bariatric Surgery

Study Overview
=================
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).

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged between 18 to 65 years old. Planned to undergo either primary gastric bypass surgery or primary sleeve gastrectomy surgery and fulfilling NICE eligibility criteria for bariatric surgery. Medically safe to participate in exercise programme. Able to read and write in English. Willing and able to provide written informed consent. Able to comply with study protocol. Able to attend a supervised tailored exercise session at UCLH weekly for 12 weeks. Willing and able to wear a Fitbit wrist-based activity tracker device and an Actigraph device. Exclusion Criteria: More than 200 kg of body weight (due to limitation of DXA Scanner). Non-ambulatory. Functional limitation. Medical contraindication for exercise.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>usual care provided by the NHS for patients undergoing bariatric surgery. | |
| Experimental: Intervention<br>usual care + BARI-LIFESTYLE intervention | Behavioral: Lifestyle intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %WL | The primary objective of this trial is to compare the 1-year post-surgery percentage weight loss (%WL) in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body fat | To compare post-surgery changes in body fat assessed using DXA scanning relative to pre-surgery at 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 52 weeks | 
| bone mineral density | To compare post-surgery changes in bone mineral density assessed using DXA scanning relative to pre-surgery at 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 52 weeks | 
| skeletal muscle mass | To compare post-surgery changes in skeletal muscle mass, relative to pre-surgery at 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 52 weeks | 
| physical activity (PA) levels | To compare post-surgery changes in physical activity (PA) levels (light, moderate, vigorous) at 3, 6, and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme using Actigraph assessments. | 12, 26 and 52 weeks | 
| 150 minutes of activity | To compare post-surgery changes in percentage achieving 150 minutes of moderate to vigorous PA (MVPA) in a week at 3, 6, and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme using Actigraph assessments. | 12, 26 and 52 weeks | 
| sedentary time | To compare post-surgery changes in sedentary time at 3, 6, and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme using Actigraph assessments. | 12, 26 and 52 weeks | 
| 6MWT | To compare post-surgery changes in physical fitness assessed using 6-minute walk tests (6MWT) at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 12, 26 and 52 weeks | 
| STS | To compare post-surgery changes in physical fitness assessed using sit-to-stand (STS) test at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 12, 26 and 52 weeks | 
| Handgrip test | To compare post-surgery changes in handgrip test at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 12, 26 and 52 weeks | 
| 36-Item Short-Form Health Survey Instrument (SF-36) | To compare post-surgery changes in health-related quality of life. | 12, 26 and 52 weeks | 
| Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | To compare post-surgery changes in health-related quality of life. | 12, 26 and 52 weeks | 
| Beck Depression Inventory (BDI) | To compare post-surgery changes in characteristics of attitude and symptoms of depression assessed using Beck Depression Inventory (BDI) at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 12, 26 and 52 weeks | 
| Medical history | To compare post-surgery changes in obesity-associated comorbidities (type 2 diabetes, dyslipidaemia, hypertension, obstructive sleep apnoea) at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme. | 12, 26 and 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, healthy lifestyle