Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06910735
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT06910735
Study Brief:
Protocol Section:
NCT06910735