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

March 28, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Effect of Financial Incentives on Weight Loss in Patients With Failed Bariatric Surgery: A Multicenter Randomized Open-Label Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
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
Experimental: Threshold financial incentive
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.
Experimental: Proportional financial incentive
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in body weight
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in body weight
Time Frame: 24 months
24 months
Change from Baseline in blood pressure
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in Fasting Plasma Glucose
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in Glycated hemoglobin
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in Total Cholesterol
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in High-density Lipoproteins
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in Low-density Lipoproteins
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in Triglycerides
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in AST levels
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in ALT levels
Time Frame: 6, 12, 18, 24 months
6, 12, 18, 24 months
Change from Baseline in the adherence to multivitamins intake
Time Frame: 6, 12, 18, 24 months
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
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
6, 12, 18, 24 months
Rate of participants who achieve the predefined weight loss target
Time Frame: 12, 24 months
12, 24 months
Difference in incremental cost-effectiveness ratio
Time Frame: 12, 24 months
12, 24 months
Difference in the costs generated to the healthcare system
Time Frame: 12, 24 months
12, 24 months
Difference in the costs avoided to the healthcare system
Time Frame: 12, 24 months
12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Sébastien Czernichow, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220835
  • PREPS-21-0030 (Other Grant/Funding Number: French Ministry of Health)
  • 2023-A01309-36 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)
  • 23.02108.000240 (Other Identifier: Commission Nationale des Recherche Impliquant la Personne Humaine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.

Processing of shared data must comply with European General Data Protection Regulation (GDPR).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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