Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 5:23 PM
Study NCT ID:
NCT06910735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Financial Incentives and Weight Loss in Failed Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in body weight', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in body weight', 'timeFrame': '24 months'}, {'measure': 'Change from Baseline in blood pressure', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in Fasting Plasma Glucose', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in Glycated hemoglobin', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in Total Cholesterol', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in High-density Lipoproteins', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in Low-density Lipoproteins', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in Triglycerides', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in AST levels', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in ALT levels', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in the adherence to multivitamins intake', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in quality of life as measured by the Moorehead-Ardelt questionnaire', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Change from Baseline in quality of life as measured by the EQ-5D-5L questionnaire', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Rate of participants who achieve the predefined weight loss target', 'timeFrame': '12, 24 months'}, {'measure': 'Difference in incremental cost-effectiveness ratio', 'timeFrame': '12, 24 months'}, {'measure': 'Difference in the costs generated to the healthcare system', 'timeFrame': '12, 24 months'}, {'measure': 'Difference in the costs avoided to the healthcare system', 'timeFrame': '12, 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Financial incentive'], 'conditions': ['Obesity', 'Obesity Recidivism']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female over 18 years of age\n* Patients with a history of adjustable gastric banding, sleeve gastrectomy, gastric bypass or SADI-sleeve surgery\n* Patient with a post-operative delay of more than 2 years\n* Patient who has gained ≥10% of the maximum weight lost\n* Patient still obese (body mass index ≥ 30 kg/m²) after surgery\n\nExclusion Criteria:\n\n* Pregnant women\n* Women of childbearing potential planning a pregnancy during the first year of the study\n* Persons under legal protection (safeguard of justice, guardianship, curatorship, etc.)'}, 'identificationModule': {'nctId': 'NCT06910735', 'acronym': 'BARIACADO', 'briefTitle': 'Financial Incentives and Weight Loss in Failed Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effect of Financial Incentives on Weight Loss in Patients With Failed Bariatric Surgery: A Multicenter Randomized Open-Label Trial', 'orgStudyIdInfo': {'id': 'APHP220835'}, 'secondaryIdInfos': [{'id': 'PREPS-21-0030', 'type': 'OTHER_GRANT', 'domain': 'French Ministry of Health'}, {'id': '2023-A01309-36', 'type': 'OTHER', 'domain': 'Agence nationale de sécurité du médicament et des produits de santé'}, {'id': '23.02108.000240', 'type': 'OTHER', 'domain': 'Commission Nationale des Recherche Impliquant la Personne Humaine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Threshold financial incentive', 'interventionNames': ['Behavioral: Threshold financial incentive']}, {'type': 'EXPERIMENTAL', 'label': 'Proportional financial incentive', 'interventionNames': ['Behavioral: Proportional financial incentive']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Control']}, {'name': 'Threshold financial incentive', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Threshold financial incentive']}, {'name': 'Proportional financial incentive', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Proportional financial incentive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'contacts': [{'name': 'Sopio TATULASHVILI, MD', 'role': 'CONTACT', 'email': 'sopio.tatulashvili@aphp.fr'}], 'facility': 'AP-HP - hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '92701', 'city': 'Colombes', 'country': 'France', 'contacts': [{'name': 'Séverine LEDOUX, MD', 'role': 'CONTACT', 'email': 'severine.ledoux@aphp.fr'}], 'facility': 'AP-HP - hôpital Louis-Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'contacts': [{'name': 'Sarah BATHAEI, MD', 'role': 'CONTACT', 'email': 'sarah.bathaei@chicreteil.fr'}], 'facility': 'Centre hospitalier intercommunal de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Bénédicte GABORIT, MD', 'role': 'CONTACT', 'email': 'benedicte.gaborit@ap-hm.fr'}], 'facility': 'AP-HM - hôpital de la Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'David JACOBI, MD', 'role': 'CONTACT', 'email': 'david.jacobi@chu-nantes.fr'}], 'facility': 'CHU de Nantes - hôpital Laënnec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '45100', 'city': 'Orléans', 'country': 'France', 'contacts': [{'name': 'Adel ABOU-MRAD, MD', 'role': 'CONTACT', 'email': 'adel.abou-mrad@chr-orleans.fr'}], 'facility': "CHR d'Orléans - hôpital La Source", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Judith ARON WISNEWSKY, MD', 'role': 'CONTACT', 'email': 'judith.aron-wisnewsky@aphp.fr'}], 'facility': 'AP-HP - hôpital de la Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Sébastien CZERNICHOW, MD', 'role': 'CONTACT', 'email': 'sebastien.czernichow@aphp.fr'}], 'facility': 'AP-HP - hôpital européen Georges-Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Tigran POGHOSYAN, MD', 'role': 'CONTACT', 'email': 'tigran.poghosyan@aphp.fr'}], 'facility': 'AP-HP - hôpital Bichat - Claude-Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Mathilde MERCKX FRATY, MD', 'role': 'CONTACT', 'email': 'mathilde.merckx-fraty@chu-poitiers.fr'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'contacts': [{'name': 'Ana DIAZ CIVES, MD', 'role': 'CONTACT', 'email': 'adiazcives@chu-reims.fr'}], 'facility': 'CHU de Reims - hôpital Robert-Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'contacts': [{'name': 'Didier QUILLIOT, MD', 'role': 'CONTACT', 'email': 'd.quilliot@chu-nancy.fr'}], 'facility': 'CHU de Nancy - hôpital Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Coralie Villeret', 'role': 'CONTACT', 'email': 'coralie.villeret@aphp.fr', 'phone': '+33 1 40 27 52 66'}], 'overallOfficials': [{'name': 'Sébastien Czernichow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.', 'accessCriteria': '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.\n\nTeams 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.\n\nProcessing of shared data must comply with European General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}