Evaluation of a Lifestyle Intervention After Bariatric Surgery

April 26, 2021 updated by: University College, London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University College London Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%WL
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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
Time Frame: 12, 26 and 52 weeks
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
Time Frame: 12, 26 and 52 weeks
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
Time Frame: 12, 26 and 52 weeks
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
Time Frame: 12, 26 and 52 weeks
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
Time Frame: 12, 26 and 52 weeks
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
Time Frame: 12, 26 and 52 weeks
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)
Time Frame: 12, 26 and 52 weeks
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)
Time Frame: 12, 26 and 52 weeks
To compare post-surgery changes in health-related quality of life.
12, 26 and 52 weeks
Beck Depression Inventory (BDI)
Time Frame: 12, 26 and 52 weeks
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
Time Frame: 12, 26 and 52 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Rachel L Batterham, PhD FRCP, UCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2018

Primary Completion (Actual)

December 21, 2020

Study Completion (Actual)

December 21, 2020

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16/0232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

To be discussed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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