Treatment of Loss of Control Eating Following Bariatric Surgery

减肥手术后饮食失控的治疗

• 批准号: 8631388
• 负责人: CARLOS M GRILO
• 金额: $ 44.91万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-15 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8631388
• 关键词: Aftercare; Ally; Applications Grants; Arts; Attention; Bariatrics; Behavior Therapy; Behavioral; Body Image; Body Weight decreased; Caring; Cognitive Therapy; Comorbidity; Disease; Eating; Eating Behavior; Effectiveness; Evaluation; Funding; Gastric Bypass; Goals; Health; Heterogeneity; Impairment; Longitudinal Studies; Maintenance; Mediator of activation protein; Medical; Methods; Obesity; Operative Surgical Procedures; Outcome; Outcome Assessment; Outcome Study; Patients; Randomized; Randomized Controlled Trials; Relative (related person); Reporting; Research; Risk; Testing; Treatment Cost; Treatment outcome; Weight; bariatric surgery; clinical care; cost; cost effective; cost effectiveness; experience; follow-up; improved; loss of control over eating; loss of function; prognostic; programs; psychosocial; public health relevance; self help; weight maintenance

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.

该赠款申请寻求资金进行随机对照试验，以测试两个 为肥胖患者提供指导自助治疗 胃搭桥手术。目的是确定低成本且易于删除的行为方法 改善长期的减肥手术结果。尽管减肥手术会产生大量的体重 许多患者的医疗合并症的损失和改善，结果研究发现体重 术后一年开始重新开始发生。研究还记录了改进 饮食行为和减肥手术后的功能，尽管长期研究报告了 在这些结果中存在很大的异质性。饮食行为无序是在减肥后常见的 外科手术。鉴于对减肥和心理社会成果的异质性，减肥 手术，研究试图确定结果的预测指标。虽然饮食行为无序 手术（以及许多其他患者预测因素）尚未显示出负面的预后意义，LOC后 已经发现手术可靠地预测体重减轻和功能较差。可以可靠地评估LOC 在肥胖患者中，已经显示有现有方法和LOC的减肥患者高度 对认知行为疗法（CBT）的反应，包括成本 - 有效，可以传播到手术计划。 在这项研究中，n = 120个胃旁路患者经历了经常在手术后经历LOC的患者 随机分为两个实验条件之一（GSHCBT或GSHBWL（即行为减肥））或 护理标准（SOC）比较条件。评估LOC和随机治疗的评估将是 手术后6个月。盟军健康 临床医生增加对减肥手术环境的普遍性，并且因为存在支持其 非专业临床医生的有效传播。通过治疗过程的变化将是 评估和重大结果评估将由独立评估者在基线时进行（6个月 手术后），治疗后（手术后9个月），每六个重复的随访评估 完成治疗后24个月（手术后33个月）。全面评估 将评估体重维持，LOC，饮食行为和相关结果（行为和 社会心理功能）。计划的分析将测试GSHCBT和GSHBWL相对于 护理标准的比较条件，相对于彼此减少LOC饮食和增强 长期手术后体重维持和社会心理结局。探索性分析将测试 潜在的预测因素，主持人和结果的调解人，并提供成本效益的估计。