Evaluation of a Remotely-Delivered Behavioral Intervention for Post-Bariatric Surgery Weight Regain

项目摘要/摘要 这项拟议的研究旨在评估远程交付、基于验收的 行为干预(ABTI)对减肥手术后体重恢复的比较 它进入了控制状态。目前的研究目的是：1)评估Abti对体重结果的疗效 以控制；2)评估Abti对次要结果的疗效，包括改善饮食行为， 体力活动和医疗条件与对照组的比较；3)测试提出的作用机制， 包括评估a)如果Abti中假设的有效成分的变化调节体重的差异 条件和b)饮食行为和主观内部状态之间的关联 (即，饥饿、渴望、冲动、负面影响)在Abti与Control相比会减弱。病人6至48 手术后几个月体重恢复5%的人将被随机分配到Abti组或对照组 200例。评估将在基线、3、6(积极治疗结束)和12个月(随访)进行。 在注册之后。开发创新的干预措施逆转术后体重回升是至关重要的 在不断增长的没有经历最佳手术的患者群体中保持手术的健康益处 术后结果。

PROJECT SUMMARY/ABSTRACT The proposed study is designed to evaluate the efficacy of a remotely-delivered, acceptance-based behavioral intervention (ABTi) for individuals demonstrating weight regain after bariatric surgery by comparing it to a Control condition. The current study aims to: 1) evaluate ABTi's efficacy on weight outcomes compared to Control; 2) evaluate ABTi's efficacy on secondary outcomes including improvements in eating behaviors, physical activity, and medical conditions compared to Control; 3) test proposed mechanisms of action, including evaluating a) if changes in hypothesized active ingredients in ABTi mediate differences in weight outcomes between conditions and b) if the association between eating behavior and subjective internal states (i.e., hunger, cravings, urges, negative affect) will weaken in ABTi compared to Control. Patients 6 to 48 months out from surgery who have regained >5% of their weight will be randomized to ABTi or Control (n=200). Assessments willbe conducted at baseline, 3, 6 (end of active treatment), and 12 months (follow up) after enrollment. Developing innovative interventions to reverse postoperative weight regain is crucial to maintain the health benefits of surgery in this growing population of patients not experiencing optimal postoperative results.