Financial Incentives and Weight Loss in Failed Bariatric Surgery
BARIACADO
Effect of Financial Incentives on Weight Loss in Patients With Failed Bariatric Surgery: A Multicenter Randomized Open-Label Trial
4 other identifiers
interventional
264
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Apr 2025
Longer than P75 for not_applicable obesity
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
April 4, 2025
March 1, 2025
3 years
March 28, 2025
March 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in body weight
12 months
Secondary Outcomes (17)
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
- +12 more secondary outcomes
Study Arms (3)
Control
OTHERThreshold financial incentive
EXPERIMENTALProportional financial incentive
EXPERIMENTALInterventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
AP-HP - hôpital Avicenne
Bobigny, 93000, France
AP-HP - hôpital Louis-Mourier
Colombes, 92701, France
Centre hospitalier intercommunal de Créteil
Créteil, 94000, France
AP-HM - hôpital de la Conception
Marseille, 13005, France
CHU de Nantes - hôpital Laënnec
Nantes, 44093, France
CHR d'Orléans - hôpital La Source
Orléans, 45100, France
AP-HP - hôpital de la Pitié-Salpêtrière
Paris, 75013, France
AP-HP - hôpital européen Georges-Pompidou
Paris, 75015, France
AP-HP - hôpital Bichat - Claude-Bernard
Paris, 75018, France
CHU de Poitiers
Poitiers, 86000, France
CHU de Reims - hôpital Robert-Debré
Reims, 51092, France
CHU de Nancy - hôpital Brabois
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sébastien Czernichow, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 4, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
April 4, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Two years after the last publication
- 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).
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.