Effect of Financial Incentives on Weight Loss in Patients With Failed Bariatric Surgery: A Multicenter Randomized Open-Label Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 264
- Locations
- 12
- Primary Endpoint
- Change from Baseline in body weight
Study Overview
Brief Summary
This national, prospective, multicenter, and randomized study seeks to evaluate the effect of financial incentives on weight loss in individuals who experience weight regain following bariatric surgery. The study also aims to conduct a cost-utility analysis to measure the effectiveness of the intervention and assess the potential budgetary implications if it were to be implemented on a wider scale.
Detailed Description
Our intervention is based on the principle of "contingency management" whereby financial rewards are contingent upon meeting specific weight loss targets. To assess the effectiveness of this approach, patients who have experienced weight regain after bariatric surgery will be randomly assigned to one of three groups. Group 1 will receive the standard care that includes setting a weight-loss target based on the weight achieved at 12 months post-bariatric surgery following the standard multidisciplinary follow-up at the inclusion center. Group 2 will receive the same treatment as the control group (Group 1), but with an additional financial incentive if the weight loss target (corresponding to the weight they reached 12 months after bariatric surgery) is achieved 12 months after inclusion. Group 3 will receive the same treatment as the control group (Group 1), but the financial incentive will be proportional to the actual weight loss achieved relative to the weight loss target (corresponding to the weight they reached 12 months after bariatric surgery).
The study will include a standard post-bariatric surgery follow-up visits scheduled at 6, 12, 18, and 24 months, as per routine practice. At the 12-month visit, participants will be eligible to receive a financial incentive based on their arm assignment and the extent of weight loss achieved. After the 12-month visit, participants will not receive any additional financial incentives until the 24-month visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female over 18 years of age
- •Patients with a history of adjustable gastric banding, sleeve gastrectomy, gastric bypass or SADI-sleeve surgery
- •Patient with a post-operative delay of more than 2 years
- •Patient who has gained ≥10% of the maximum weight lost
- •Patient still obese (body mass index ≥ 30 kg/m²) after surgery
Exclusion Criteria
- •Pregnant women
- •Women of childbearing potential planning a pregnancy during the first year of the study
- •Persons under legal protection (safeguard of justice, guardianship, curatorship, etc.)
Arms & Interventions
Proportional financial incentive
Intervention: Proportional financial incentive (Behavioral)
Control
Intervention: Control (Other)
Threshold financial incentive
Intervention: Threshold financial incentive (Behavioral)
Outcomes
Primary Outcomes
Change from Baseline in body weight
Time Frame: 12 months
Secondary Outcomes
- Change from Baseline in Fasting Plasma Glucose(6, 12, 18, 24 months)
- Difference in incremental cost-effectiveness ratio(12, 24 months)
- Change from Baseline in quality of life as measured by the Moorehead-Ardelt questionnaire(6, 12, 18, 24 months)
- Change from Baseline in ALT levels(6, 12, 18, 24 months)
- Change from Baseline in the adherence to multivitamins intake(6, 12, 18, 24 months)
- Change from Baseline in body weight(24 months)
- Change from Baseline in blood pressure(6, 12, 18, 24 months)
- Change from Baseline in Glycated hemoglobin(6, 12, 18, 24 months)
- Change from Baseline in Total Cholesterol(6, 12, 18, 24 months)
- Change from Baseline in High-density Lipoproteins(6, 12, 18, 24 months)
- Change from Baseline in Low-density Lipoproteins(6, 12, 18, 24 months)
- Change from Baseline in Triglycerides(6, 12, 18, 24 months)
- Change from Baseline in AST levels(6, 12, 18, 24 months)
- Change from Baseline in quality of life as measured by the EQ-5D-5L questionnaire(6, 12, 18, 24 months)
- Rate of participants who achieve the predefined weight loss target(12, 24 months)
- Difference in the costs generated to the healthcare system(12, 24 months)
- Difference in the costs avoided to the healthcare system(12, 24 months)