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NCT Number: NCT06910735

Financial Incentives and Weight Loss in Failed Bariatric Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP - hôpital Avicenne, Bobigny, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Control

Other

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 incentive

Behavioral

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 incentive

Behavioral

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 outcomes

  1. Change from Baseline in body weight

    Time frame: 12 months

Secondary outcomes

  1. Change from Baseline in body weight

    Time frame: 24 months

  2. Change from Baseline in blood pressure

    Time frame: 6, 12, 18, 24 months

  3. Change from Baseline in Fasting Plasma Glucose

    Time frame: 6, 12, 18, 24 months

  4. Change from Baseline in Glycated hemoglobin

    Time frame: 6, 12, 18, 24 months

  5. Change from Baseline in Total Cholesterol

    Time frame: 6, 12, 18, 24 months

  6. Change from Baseline in High-density Lipoproteins

    Time frame: 6, 12, 18, 24 months

  7. Change from Baseline in Low-density Lipoproteins

    Time frame: 6, 12, 18, 24 months

  8. Change from Baseline in Triglycerides

    Time frame: 6, 12, 18, 24 months

  9. Change from Baseline in AST levels

    Time frame: 6, 12, 18, 24 months

  10. Change from Baseline in ALT levels

    Time frame: 6, 12, 18, 24 months

  11. Change from Baseline in the adherence to multivitamins intake

    Time frame: 6, 12, 18, 24 months

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

    Time frame: 6, 12, 18, 24 months

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

    Time frame: 6, 12, 18, 24 months

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

    Time frame: 12, 24 months

  15. Difference in incremental cost-effectiveness ratio

    Time frame: 12, 24 months

  16. Difference in the costs generated to the healthcare system

    Time frame: 12, 24 months

  17. Difference in the costs avoided to the healthcare system

    Time frame: 12, 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Coralie Villeret

CONTACT

[email protected]

+33 1 40 27 52 66

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: BARIACADO

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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