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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
264
Participants 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
Participants will receive the standard care with an additional financial incentive of 300 € if they successfully achieve the weight loss target corresponding to their weight at 12 months after bariatric surgery. This financial incentive will be awarded 12 months after their inclusion in the study.
Participants will receive the standard care with an additional financial incentive, which will be determined based on the proportion of their actual weight loss in relation to the predefined weight loss target corresponding to their weight at 12 months after bariatric surgery. The financial incentive can be up to 300 € if the weight loss target is achieved 12 months after their inclusion in the study.
AP-HP - hôpital Avicenne
Bobigny, France
AP-HP - hôpital Louis-Mourier
Colombes, France
Centre hospitalier intercommunal de Créteil
Créteil, France
Change from Baseline in body weight
Time frame: 12 months
Change from Baseline in body weight
Time frame: 24 months
Change from Baseline in blood pressure
Time frame: 6, 12, 18, 24 months
Change from Baseline in Fasting Plasma Glucose
Time frame: 6, 12, 18, 24 months
Change from Baseline in Glycated hemoglobin
Time frame: 6, 12, 18, 24 months
Change from Baseline in Total Cholesterol
Time frame: 6, 12, 18, 24 months
Change from Baseline in High-density Lipoproteins
Time frame: 6, 12, 18, 24 months
Change from Baseline in Low-density Lipoproteins
Time frame: 6, 12, 18, 24 months
Change from Baseline in Triglycerides
Time frame: 6, 12, 18, 24 months
Change from Baseline in AST levels
Time frame: 6, 12, 18, 24 months
Change from Baseline in ALT levels
Time frame: 6, 12, 18, 24 months
Change from Baseline in the adherence to multivitamins intake
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AP-HM - hôpital de la Conception
Marseille, France
CHU de Nantes - hôpital Laënnec
Nantes, France
CHR d'Orléans - hôpital La Source
Orléans, France
AP-HP - hôpital de la Pitié-Salpêtrière
Paris, France
AP-HP - hôpital européen Georges-Pompidou
Paris, France
AP-HP - hôpital Bichat - Claude-Bernard
Paris, France
CHU de Poitiers
Poitiers, France
...and 2 more locations
Time frame: 6, 12, 18, 24 months
Change from Baseline in quality of life as measured by the Moorehead-Ardelt questionnaire
Time frame: 6, 12, 18, 24 months
Change from Baseline in quality of life as measured by the EQ-5D-5L questionnaire
Time frame: 6, 12, 18, 24 months
Rate of participants who achieve the predefined weight loss target
Time frame: 12, 24 months
Difference in incremental cost-effectiveness ratio
Time frame: 12, 24 months
Difference in the costs generated to the healthcare system
Time frame: 12, 24 months
Difference in the costs avoided to the healthcare system
Time frame: 12, 24 months