Financial Incentives and Weight Loss in Failed Bariatric Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Control
  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
• Поведенческое Threshold financial incentive
  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.
• Поведенческое Proportional financial incentive
  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.

Первичные конечные точки

• Change from Baseline in body weight [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Change from Baseline in body weight [Срок оценки: 24 months]
• Change from Baseline in blood pressure [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in Fasting Plasma Glucose [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in Glycated hemoglobin [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in Total Cholesterol [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in High-density Lipoproteins [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in Low-density Lipoproteins [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in Triglycerides [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in AST levels [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in ALT levels [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in the adherence to multivitamins intake [Срок оценки: 6, 12, 18, 24 months]
• Change from Baseline in quality of life as measured by the Moorehead-Ardelt questionnaire [Срок оценки: 6, 12, 18, 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 12 центров

• AP-HP - hôpital Avicenne — Bobigny
• AP-HP - hôpital Louis-Mourier — Colombes
• Centre hospitalier intercommunal de Créteil — Créteil
• AP-HM - hôpital de la Conception — Marseille
• CHU de Nantes - hôpital Laënnec — Nantes
• CHR d'Orléans - hôpital La Source — Orléans
• AP-HP - hôpital de la Pitié-Salpêtrière — Paris
• AP-HP - hôpital européen Georges-Pompidou — Paris
• … и ещё 4 центра

Идентификаторы

NCT: NCT06910735 · APHP220835 · PREPS-21-0030 · 2023-A01309-36 · 23.02108.000240

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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