Health TrialsbyHealthPanel

Financial Incentives and Weight Loss in Failed Bariatric Surgery

ConditionsObesityObesity Recidivism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Control

    Other intervention

    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.

Treatment groups

264 Participants
are divided into 3 treatment groups
Group A: ControlOther 1 intervention
Group B: Threshold financial incentiveExperimental treatment 1 intervention
Group C: Proportional financial incentiveExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Ministry of Health, France

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: