Evaluation of a Lifestyle Intervention After Bariatric Surgery

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214471
• Other study ID #: 16/0232
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: December 21, 2020

Study information

• Verified date: April 2021
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

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.

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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