Treatment of Loss of Control Eating Following Bariatric Surgery

描述（由申请人提供）：本拨款申请寻求资金进行一项随机对照试验，测试两种指导自助治疗对胃分流手术后饮食失控（LOC）的肥胖患者的有效性。目标是确定低成本和易于传播的行为方法，以改善长期减肥手术的结果。虽然减肥手术在许多患者中产生了大量的体重减轻和医疗合并症的改善，但结果研究发现，早在手术后一年，体重就开始恢复。研究也记录了减肥手术后饮食行为和功能的改善，尽管长期研究报告了这些结果的相当大的异质性。减肥手术后饮食失调很常见。考虑到减肥手术后体重减轻和心理社会结果的异质性，研究试图确定结果的预测因素。虽然手术前的饮食行为紊乱（和许多其他患者预测因素）没有显示出负面的预后意义，但术后LOC已被发现可靠地预测较差的体重减轻和功能。现有方法可以可靠地评估肥胖患者的LOC，并且在肥胖患者中，LOC对认知行为治疗（CBT）反应高度敏感，包括引导自助（gshCBT）方法，这些方法具有成本效益，可以推广到手术方案中。在本研究中，N=120名胃分流术术后定期发生LOC的患者将被随机分配到两种实验条件之一（gshCBT或gshBWL（即行为减肥））或标准护理（SOC）比较条件。LOC评估和治疗随机化将在术后6个月进行。治疗将由联合健康临床医生在三个月内通过指导自助进行，以增加减肥手术设置的普遍性，因为已有证据表明其有效性

DESCRIPTION (provided by applicant): 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.