Financial Incentives and Weight Loss in Failed Bariatric Surgery

Not Applicable

Not yet recruiting

• Conditions: Obesity; Obesity Recidivism

• Registration Number: NCT06910735
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study Start: 2025-04
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2028-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 264

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in body weight	12 months

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in body weight	24 months
Change from Baseline in blood pressure	6, 12, 18, 24 months
Change from Baseline in Fasting Plasma Glucose	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 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 quality of life as measured by the Moorehead-Ardelt questionnaire	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 incremental cost-effectiveness ratio	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

Trial Locations

Locations (12)

AP-HP - hôpital Avicenne; 🇫🇷 Bobigny, France

AP-HP - hôpital Louis-Mourier; 🇫🇷 Colombes, France

Centre hospitalier intercommunal de Créteil; 🇫🇷 Créteil, France

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

CHU de Reims - hôpital Robert-Debré; 🇫🇷 Reims, France

CHU de Nancy - hôpital Brabois; 🇫🇷 Vandœuvre-lès-Nancy, France