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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other |
| |
| Threshold financial incentive | Experimental |
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| Proportional financial incentive | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in body weight | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Coralie Villeret | Contact | +33 1 40 27 52 66 | coralie.villeret@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sébastien Czernichow, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP - hôpital Avicenne | Bobigny | 93000 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Two years after the last publication
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).
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| 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 |
| Change from Baseline in High-density Lipoproteins | 6, 12, 18, 24 months |
| Change from Baseline in Low-density Lipoproteins | 6, 12, 18, 24 months |
| Change from Baseline in Triglycerides | 6, 12, 18, 24 months |
| Change from Baseline in AST levels | 6, 12, 18, 24 months |
| Change from Baseline in ALT levels | 6, 12, 18, 24 months |
| Change from Baseline in the adherence to multivitamins intake | 6, 12, 18, 24 months |
| Change from Baseline in quality of life as measured by the Moorehead-Ardelt questionnaire | 6, 12, 18, 24 months |
| Change from Baseline in quality of life as measured by the EQ-5D-5L questionnaire | 6, 12, 18, 24 months |
| Rate of participants who achieve the predefined weight loss target | 12, 24 months |
| Difference in incremental cost-effectiveness ratio | 12, 24 months |
| Difference in the costs generated to the healthcare system | 12, 24 months |
| Difference in the costs avoided to the healthcare system | 12, 24 months |
| AP-HP - hôpital Louis-Mourier | Colombes | 92701 | France |
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| Centre hospitalier intercommunal de Créteil | Créteil | 94000 | France |
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| AP-HM - hôpital de la Conception | Marseille | 13005 | France |
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| CHU de Nantes - hôpital Laënnec | Nantes | 44093 | France |
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| CHR d'Orléans - hôpital La Source | Orléans | 45100 | France |
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| AP-HP - hôpital de la Pitié-Salpêtrière | Paris | 75013 | France |
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| AP-HP - hôpital européen Georges-Pompidou | Paris | 75015 | France |
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| AP-HP - hôpital Bichat - Claude-Bernard | Paris | 75018 | France |
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| CHU de Poitiers | Poitiers | 86000 | France |
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| CHU de Reims - hôpital Robert-Debré | Reims | 51092 | France |
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| CHU de Nancy - hôpital Brabois | Vandœuvre-lès-Nancy | 54500 | France |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |