Clinical trial NCT06910735: Financial Incentives and Weight Loss in Failed Bariatric Surgery
Official title: Effect of Financial Incentives on Weight Loss in Patients With Failed Bariatric Surgery: A Multicenter Randomized Open-Label Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Obesity Recidivism
Keywords: Bariatric surgery
Financial incentive
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2025-04-04
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change from Baseline in body weight
timeFrame: 12 months
Secondary outcomes:
measure: Change from Baseline in body weight
timeFrame: 24 months
measure: Change from Baseline in blood pressure
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in Fasting Plasma Glucose
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in Glycated hemoglobin
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in Total Cholesterol
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in High-density Lipoproteins
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in Low-density Lipoproteins
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in Triglycerides
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in AST levels
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in ALT levels
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in the adherence to multivitamins intake
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in quality of life as measured by the Moorehead-Ardelt questionnaire
timeFrame: 6, 12, 18, 24 months
measure: Change from Baseline in quality of life as measured by the EQ-5D-5L questionnaire
timeFrame: 6, 12, 18, 24 months
measure: Rate of participants who achieve the predefined weight loss target
timeFrame: 12, 24 months
measure: Difference in incremental cost-effectiveness ratio
timeFrame: 12, 24 months
measure: Difference in the costs generated to the healthcare system
timeFrame: 12, 24 months
measure: Difference in the costs avoided to the healthcare system
timeFrame: 12, 24 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: AP-HP - hôpital Avicenne
city: Colombes
country: France
facility: AP-HP - hôpital Louis-Mourier
city: Créteil
country: France
facility: Centre hospitalier intercommunal de Créteil
city: Marseille
country: France
facility: AP-HM - hôpital de la Conception
city: Nantes
country: France
facility: CHU de Nantes - hôpital Laënnec
city: Orléans
country: France
facility: CHR d'Orléans - hôpital La Source
city: Paris
country: France
facility: AP-HP - hôpital de la Pitié-Salpêtrière
city: Paris
country: France
facility: AP-HP - hôpital européen Georges-Pompidou
city: Paris
country: France
facility: AP-HP - hôpital Bichat - Claude-Bernard
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CHU de Reims - hôpital Robert-Debré
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy - hôpital Brabois
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sébastien Czernichow, MD
role: PRINCIPAL_INVESTIGATOR
References: