Treatment of Loss of Control Eating Following Bariatric Surgery

这项赠款申请寻求资金来执行一项随机对照试验，测试两种药物的有效性 饮食失控(LOC)后肥胖患者的自助式指导治疗 胃旁路手术。目标是确定低成本和易于传播的行为方法 改善长期减肥手术结果。尽管减肥手术产生了相当大的体重 在许多患者中，医疗合并症的减少和改善，结果研究发现，体重 复发最早发生在术后一年。研究还记录了在以下方面的改进 减肥手术后的饮食行为和功能，尽管有较长期的研究报告 这些结果有相当大的异质性。饮食失调是减肥后常见的行为 做手术。考虑到人们对减肥后体重和心理社会结果的异质性的担忧 在手术方面，研究试图确定预后的预测因素。尽管之前饮食行为不规律 对于手术(和许多其他患者预测因素)，LOC术后并未显示出负面预后意义 手术被发现可以可靠地预测更差的体重减轻和功能。可以可靠地评估LoC 在肥胖患者中，用现有的方法和LOC已被证明是高度的 对认知行为疗法(CBT)的反应，包括引导自助(GshCBT)方法，这些方法成本低- 有效，并可传播到外科项目。 在这项研究中，N=120名手术后定期经历LOC的胃旁路手术患者将 随机到两种实验条件之一(gshCBT或gshBWL(即行为体重减轻))或 护理标准(SOC)比较情况。LOC的评估和治疗的随机分组将在 术后6个月。治疗将由联合健康在三个月内通过导游自助提供 临床医生增加对减肥手术环境的普适性，因为他们的支持 非专科临床医生的有效传播。治疗过程中的变化将是 评价和主要成果评估将由独立评价员按基线(6个月)进行 术后)、治疗后(术后9个月)和每六个月一次的重复随访评估。 在完成治疗后6个月至24个月(术后33个月)。综合评价 将评估体重维持、LOC、饮食行为和相关结果(行为和 心理社会功能)。计划中的分析将测试gshCBT和gshBWL相对于 减少低摄入量和提高摄入量的护理标准对比条件和相互关系 手术后长期的体重维持和心理社会结果。探索性分析将测试 潜在的结果预测者、主持人和调解人，并提供成本效益估计。

This grant application seeks funds to perform a randomized controlled trial testing the effectiveness of two guided-self-help treatments for obese patients who experience loss of control over eating (LOC) following gastric bypass surgery. The goal is to identify low-cost and easy-to-disseminate behavioral methods for improving longer-term bariatric surgery outcomes. Although bariatric surgery produces substantial weight losses and improvements in medical co-morbidities in many patients, outcome studies have found that weight regain begins to occur as early as one year postoperatively. Research has also documented improvements in eating behaviors and functioning following bariatric surgery although longer-term studies have reported considerable heterogeneity in these outcomes. Disordered eating behaviors are common following bariatric surgery. Given concerns about heterogeneity of weight loss and psychosocial outcomes following bariatric surgery, research has attempted to identify predictors of outcomes. Although disordered eating behaviors prior to surgery (and many other patient predictors) have not shown negative prognostic significance, LOC post- surgery has been found to reliably predict poorer weight loss and functioning. LOC can be reliably assessed in bariatric patients with existing methods and LOC has been shown, among obese patients, to be highly responsive to cognitive behavioral therapy (CBT) including guided self-help (gshCBT) methods that are cost- effective and can be disseminated to surgery programs. In this study, N=120 gastric bypass patients who experience LOC regularly following surgery will be randomized to one of two experimental conditions (gshCBT or gshBWL (i.e., behavioral weight loss)) or to a standard-of-care (SOC) comparison condition. Assessment of LOC and randomization to treatment will be at 6-months post-surgery. Treatments will be delivered via guided-self-help over three months by allied health clinicians to increase generalizability to bariatric surgery settings and because there exists support for their effective dissemination by non-specialist clinicians. Changes through the course of treatments will be evaluated and major outcome assessments will be conducted by independent evaluators at baseline (6 months post-surgery), post-treatment (9 months post-surgery), and at repeated follow-up assessments every six- months through 24 months after completing treatments (33 months post-surgery). Comprehensive evaluations will assess weight maintenance, LOC, eating behaviors, and associated outcomes (behavioral and psychosocial functioning). Planned analyses will test the effectiveness of gshCBT and gshBWL relative to the standard-of-care comparison condition and relative to each other for reducing LOC eating and enhancing longer-term post-surgical weight maintenance and psychosocial outcomes. Exploratory analyses will test potential predictors, moderators, and mediators of outcomes and provide estimates of cost-effectiveness.