Treatment of Loss of Control Eating Following Bariatric Surgery

减肥手术后饮食失控的治疗

• 批准号: 9037006
• 负责人: CARLOS M GRILO
• 金额: $ 43.82万
• 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/9037006
• 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; Patient-Focused Outcomes; Patients; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Testing; Treatment Cost; Treatment outcome; Weight; bariatric surgery; behavioral outcome; clinical care; cost; cost effective; cost effectiveness; experience; follow-up; improved; improved outcome; loss of control over eating; loss of function; outcome prediction; prognostic significance; programs; psychosocial; reduced food intake; 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）：本赠款申请寻求资金进行随机对照试验，该试验测试两种指导自助治疗的有效性，对胃旁路手术后经历饮食失控（LOC）的肥胖患者的有效性。目的是确定低成本且易于降低的行为方法，以改善长期的减肥手术结果。尽管减肥手术在许多患者中会产生大量的体重减轻和医疗合并症的改善，但结果研究发现，术后一年的体重重新开始发生。研究还记录了减肥手术后的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异质性。饮食行为无序是在减肥手术后常见的。考虑到减肥手术后体重减轻和社会心理结局的异质性的关注，研究试图确定结果的预测指标。尽管手术前（以及许多其他患者预测因素）饮食行为障碍尚未显示出负预后意义，但已发现LOC手术可靠地预测体重减轻和功能较差。可以在具有现有方法的减肥患者中可靠地评估LOC，并且在肥胖患者中，LOC对认知行为疗法（CBT）具有很高的反应，包括具有成本效益的指导性自助（GSHCBT）方法，并且可以对手术计划进行分散。在这项研究中，n = 120例经历了经常在手术后经历LOC的胃旁路患者将被随机分为两个实验条件之一（GSHCBT或GSHBWL（即行为体重减轻））或现成标准（SOC）比较条件。对LOC和随机治疗的评估将在手术后6个月进行。盟军健康临床医生将通过三个月来通过指导自助力进行治疗，以提高对减肥手术环境的概括性，并且因为是否有支持其有效 非专业临床医生的传播。将评估通过治疗过程的变化，并将在基线（手术后6个月），治疗后（手术后9个月）进行重大结果评估，并在完成治疗后每六个月至24个月重复进行随访评估（33个月后进行33个月）。全面的评估将评估体重维持，LOC，饮食行为以及相关结果（行为和社会心理功能）。计划的分析将测试GSHCBT和GSHBWL相对于护理标准比较条件的有效性，并且相对于彼此相比，以减少LOC饮食并增强长期手术后体重的维持和社会心理结局。探索性分析将测试结果的潜在预测因素，主持人和介体的结果，并提供成本效益的估计。