Effect of Financial Incentives on Weight Loss in Patients With Failed Bariatric Surgery: A Multicenter Randomized Open-Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 264
- 试验地点
- 12
- 主要终点
- Change from Baseline in body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
研究组 & 干预措施
Proportional financial incentive
干预措施: Proportional financial incentive (Behavioral)
Control
干预措施: Control (Other)
Threshold financial incentive
干预措施: Threshold financial incentive (Behavioral)
结局指标
主要结局
Change from Baseline in body weight
时间窗: 12 months
次要结局
- Change from Baseline in Fasting Plasma Glucose(6, 12, 18, 24 months)
- Difference in incremental cost-effectiveness ratio(12, 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 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 body weight(24 months)
- Change from Baseline in blood pressure(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 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 the costs generated to the healthcare system(12, 24 months)
- Difference in the costs avoided to the healthcare system(12, 24 months)