Evaluation of a Lifestyle Intervention After Bariatric Surgery

NCT03214471 | Completed DMC

• 1 other identifier: 16/0232
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

bariatric surgery; healthy lifestyle

Outcome Measures

Primary Outcomes (1)

• %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 Outcomes (13)

• body fat

  52 weeks

• bone mineral density

  52 weeks

• skeletal muscle mass

  52 weeks

• physical activity (PA) levels

  12, 26 and 52 weeks

• 150 minutes of activity

  12, 26 and 52 weeks

Study Arms (2)

Usual Care

NO INTERVENTION

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

Intervention

EXPERIMENTAL

usual care + BARI-LIFESTYLE intervention

Behavioral: Lifestyle intervention

Interventions

Lifestyle intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Related Publications (23)

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  PMID: 37415246 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel L Batterham, PhD FRCP

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator who will conduct the follow-up assessments at each visit will be blinded to participants' allocation and will not be involved in delivering any of the intervention. The statistician conducting the data analysis will be blind to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: February 20, 2018
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)