Financial Incentives and Weight Loss in Failed Bariatric Surgery (BARIACADO)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Obesity; Obesity Recidivism

Treatments: Behavioral: Proportional financial incentive; Other: Control; Behavioral: Threshold financial incentive

Study type: Interventional

Funder types: Other

Identifiers

NCT06910735

APHP220835

2023-A01309-36 (Other Identifier)

23.02108.000240 (Other Identifier)

PREPS-21-0030 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 3 patient groups

Control

Other group

Treatment:

Other: Control

Threshold financial incentive

Experimental group

Treatment:

Behavioral: Threshold financial incentive

Proportional financial incentive

Experimental group

Treatment:

Behavioral: Proportional financial incentive