Evaluation of a Lifestyle Intervention After Bariatric Surgery
NCT ID: NCT03214471
Last Updated: 2021-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
153 participants
INTERVENTIONAL
2018-02-20
2020-12-21
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Usual Care
usual care provided by the NHS for patients undergoing bariatric surgery.
No interventions assigned to this group
Intervention
usual care + BARI-LIFESTYLE intervention
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Non-ambulatory.
3. Functional limitation.
4. Medical contraindication for exercise.
18 Years
65 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Rachel L Batterham, PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
UCL
Locations
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University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Other Identifiers
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16/0232
Identifier Type: -
Identifier Source: org_study_id
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