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

Overview

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.

Interventions

• Other Control
  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
• Behavioral Threshold financial incentive
  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.
• Behavioral Proportional financial incentive
  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.

Primary outcome measures

• Change from Baseline in body weight [Time frame: 12 months]

Secondary outcome measures (12)

• 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 [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]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

France · 12 centers

• AP-HP - hôpital Avicenne — Bobigny
• AP-HP - hôpital Louis-Mourier — Colombes
• Centre hospitalier intercommunal de Créteil — Créteil
• AP-HM - hôpital de la Conception — Marseille
• CHU de Nantes - hôpital Laënnec — Nantes
• CHR d'Orléans - hôpital La Source — Orléans
• AP-HP - hôpital de la Pitié-Salpêtrière — Paris
• AP-HP - hôpital européen Georges-Pompidou — Paris
• … and 4 more centers

Identifiers

NCT: NCT06910735 · APHP220835 · PREPS-21-0030 · 2023-A01309-36 · 23.02108.000240

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗