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ObesityBARIACADONCT06910735

Financial Incentives and Weight Loss in Failed Bariatric Surgery

A study testing Threshold financial incentive and Proportional financial incentive in people with Obesity and Obesity Recidivism, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Obesity Recidivism
What is being tested?
Threshold financial incentive and Proportional financial incentive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
12 sitesFrance
Study dates
Apr 2025to Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Coralie Villeret contact

+33 1 40 27 52 66

coralie.villeret@aphp.fr

12 sites in 1 country

France12 sites

  • AP-HP - hôpital Avicenne

    Bobigny, 93000

    Sopio TATULASHVILI, MD, sopio.tatulashvili@aphp.fr

  • AP-HP - hôpital Louis-Mourier

    Colombes, 92701

    Séverine LEDOUX, MD, severine.ledoux@aphp.fr

  • Centre hospitalier intercommunal de Créteil

    Créteil, 94000

    Sarah BATHAEI, MD, sarah.bathaei@chicreteil.fr

  • AP-HM - hôpital de la Conception

    Marseille, 13005

    Bénédicte GABORIT, MD, benedicte.gaborit@ap-hm.fr

  • CHU de Nantes - hôpital Laënnec

    Nantes, 44093

    David JACOBI, MD, david.jacobi@chu-nantes.fr

  • CHR d'Orléans - hôpital La Source

    Orléans, 45100

    Adel ABOU-MRAD, MD, adel.abou-mrad@chr-orleans.fr

  • AP-HP - hôpital de la Pitié-Salpêtrière

    Paris, 75013

    Judith ARON WISNEWSKY, MD, judith.aron-wisnewsky@aphp.fr

  • AP-HP - hôpital européen Georges-Pompidou

    Paris, 75015

    Sébastien CZERNICHOW, MD, sebastien.czernichow@aphp.fr

  • AP-HP - hôpital Bichat - Claude-Bernard

    Paris, 75018

    Tigran POGHOSYAN, MD, tigran.poghosyan@aphp.fr

  • CHU de Poitiers

    Poitiers, 86000

    Mathilde MERCKX FRATY, MD, mathilde.merckx-fraty@chu-poitiers.fr

  • CHU de Reims - hôpital Robert-Debré

    Reims, 51092

    Ana DIAZ CIVES, MD, adiazcives@chu-reims.fr

  • CHU de Nancy - hôpital Brabois

    Vandœuvre-lès-Nancy, 54500

    Didier QUILLIOT, MD, d.quilliot@chu-nancy.fr

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Control, Threshold financial incentive, Proportional financial incentive
Keywords
Bariatric surgery, Financial incentive
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ControlOther

    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

  • Threshold financial incentiveBehavioural

    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.

  • Proportional financial incentiveBehavioural

    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.

Study groups in NCT06910735
Study groupRoleWhat they receive
ControlOtherNot described
Receives: Other: Control
Threshold financial incentiveExperimentalNot described
Receives: Behavioral: Threshold financial incentive
Proportional financial incentiveExperimentalNot described
Receives: Behavioral: Proportional financial incentive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in body weight

    Measured: 12 months

Secondary outcomes (17)

  1. Change from Baseline in body weight

    Measured: 24 months

  2. Change from Baseline in blood pressure

    Measured: 6, 12, 18, 24 months

  3. Change from Baseline in Fasting Plasma Glucose

    Measured: 6, 12, 18, 24 months

  4. Change from Baseline in Glycated hemoglobin

    Measured: 6, 12, 18, 24 months

  5. Change from Baseline in Total Cholesterol

    Measured: 6, 12, 18, 24 months

  6. Change from Baseline in High-density Lipoproteins

    Measured: 6, 12, 18, 24 months

  7. Change from Baseline in Low-density Lipoproteins

    Measured: 6, 12, 18, 24 months

  8. Change from Baseline in Triglycerides

    Measured: 6, 12, 18, 24 months

  9. Change from Baseline in AST levels

    Measured: 6, 12, 18, 24 months

  10. Change from Baseline in ALT levels

    Measured: 6, 12, 18, 24 months

  11. Change from Baseline in the adherence to multivitamins intake

    Measured: 6, 12, 18, 24 months

  12. Change from Baseline in quality of life as measured by the Moorehead-Ardelt questionnaire

    Measured: 6, 12, 18, 24 months

  13. Change from Baseline in quality of life as measured by the EQ-5D-5L questionnaire

    Measured: 6, 12, 18, 24 months

  14. Rate of participants who achieve the predefined weight loss target

    Measured: 12, 24 months

  15. Difference in incremental cost-effectiveness ratio

    Measured: 12, 24 months

  16. Difference in the costs generated to the healthcare system

    Measured: 12, 24 months

  17. Difference in the costs avoided to the healthcare system

    Measured: 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study startApr 2025 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06910735
Sponsor's protocol ID
APHP220835
Other IDs
PREPS-21-0030, 2023-A01309-36, 23.02108.000240
Acronym
BARIACADO
Status last verified
Mar 2025
First submitted
28 Mar 2025
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Threshold financial incentive and Proportional financial incentive in people with Obesity and Obesity Recidivism, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Coralie Villeret (+33 1 40 27 52 66, coralie.villeret@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in body weight (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06910735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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