Treatment of Loss of Control Eating Following Bariatric Surgery

减肥手术后饮食失控的治疗

• 批准号: 9229551
• 负责人: CARLOS M GRILO
• 金额: $ 50.04万
• 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/9229551
• 关键词: Aftercare; Applications Grants; Bariatrics; Behavior Therapy; Behavioral; Body Image; Body Weight decreased; Caring; Cognitive Therapy; Comorbidity; Eating; Eating Behavior; Eating Disorders; Effectiveness; Elderly; Evaluation; Funding; Gastric Bypass; Goals; Health; Heterogeneity; Impairment; Maintenance; Mediator of activation protein; Medical; Methodology; Methods; Obesity; Operative Surgical Procedures; Outcome; Outcome Assessment; Outcome Study; Patient-Focused Outcomes; Patients; Postoperative Period; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Testing; Treatment Cost; Treatment outcome; Weight; attentional control; bariatric surgery; clinical care; cost; cost effective; cost effectiveness; experience; follow up assessment; improved; improved outcome; loss of control over eating; loss of function; obesity treatment; outcome prediction; prognostic significance; programs; psychosocial; public health relevance; reduced food intake; relative effectiveness; self help; standard of care; weight maintenance

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.

描述（由申请人提供）：这项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旁路手术后饮食失控的肥胖患者的有效性。目的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学共病的改善，但结局研究发现，体重恢复早在术后一年就开始发生。研究还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显著异质性。减肥手术后饮食紊乱的行为很常见。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。尽管手术前饮食紊乱行为（以及许多其他患者预测因素）尚未显示出负面的预后意义，但已发现手术后饮食紊乱可可靠地预测体重减轻和功能下降。可以用现有方法在肥胖患者中可靠地评估肥胖，并且在肥胖患者中，已经显示肥胖对认知行为疗法（CBT）高度响应，包括指导性自助（gshCBT）方法，其具有成本效益并且可以传播到手术计划。在该研究中，N=120名在手术后定期经历胃旁路术的患者将被随机分配到两种实验条件之一（gshCBT或gshBWL（即，行为体重减轻））或标准护理（SOC）比较状况。将在术后6个月时评估复发率并随机分配至治疗组。治疗将通过指导自助提供超过三个月的专职健康临床医生，以增加减肥手术设置的普遍性，因为存在对他们的有效支持。 非专科医生传播。将评价整个治疗过程中的变化，并由独立评价者在基线（术后6个月）、治疗后（术后9个月）和完成治疗后每6个月至24个月（术后33个月）的重复随访评估时进行主要结局评估。综合评估将评估体重维持、肥胖、饮食行为和相关结果（行为和心理社会功能）。计划的分析将测试gshCBT和gshBWL相对于标准治疗比较条件以及相对于彼此在减少暴食和增强长期术后体重维持和心理社会结局方面的有效性。探索性分析将测试结果的潜在预测因子、调节因子和介导因子，并提供成本效益估计。