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Behavioral and Pharmacological Treatments to Enhance Weight Outcomes after Metabolic and Bariatric Surgery

行为和药物治疗可增强代谢和减肥手术后的体重结果

基本信息

批准号：
10653069
负责人：
VALENTINA IVEZAJ
金额：
$ 69.99万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-19 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10653069
关键词：
Acute Adopted Adult Aftercare Behavior Therapy Behavioral Body Weight decreased Body mass index Bupropion Caring Chronic Clinical Clinical Research Combined Modality Therapy Combined Pharmacological and Behavioral Treatment Data Dietary intake Double-Blind Method Eating Eating Disorders Economic Burden Effectiveness Evidence based treatment FDA approved Future Gastrectomy Gastric Bypass Glucose Glycosylated hemoglobin A Guidelines Health Care Costs Individual Insulin Lipids Longterm Follow-up Manuals Mediator Medical Metabolic Modeling Moods Morbid Obesity Naltrexone Neck Obesity Operative Surgical Procedures Outcome Outcome Assessment Patients Pharmaceutical Preparations Pharmacological Treatment Pharmacotherapy Physical activity Placebos Prospective Studies Psychopathology Public Health Quality of life Randomized Randomized, Controlled Trials Recurrence Refractory Risk Risk Factors Stratification Subgroup Testing United States National Institutes of Health Weight Weight-Loss Drugs bariatric surgery burden of illness cardiometabolic risk cardiovascular risk factor comorbidity craving depressive symptoms design effective therapy effectiveness evaluation effectiveness testing follow up assessment food craving improved obese patients obesity treatment patient oriented pharmacologic placebo controlled study primary outcome psychosocial symptomatology treatment effect weight loss intervention

项目摘要

Project Summary. Rates of obesity and severe obesity are expected to continue to rise to alarming levels. By 2030, over 51% of adults in the US are expected to have obesity with a 130% increase in severe obesity. These staggering rates and projected future increases are deeply concerning given the substantial disease and economic burden of obesity. As severe obesity rates continue to rapidly rise, the use of metabolic and bariatric surgeries (MBS) is expected to increase. MBS is the most effective treatment for severe obesity and results in impressive acute and long-term weight loss, as well as improvement of medical and psychosocial comorbidities. Yet, weight outcomes are markedly variable after MBS, suggesting that surgery alone is not enough for a sizeable subgroup with severe obesity. Weight regain after MBS is common and a major concern, particularly because weight regain is associated with recurring or even worsening medical comorbidities. Despite the need for ongoing obesity treatment after MBS due to the chronicity of obesity and risk for regain, there is little guidance as to what treatment(s) should be provided based on empirical data. In fact, no prospective studies or randomized controlled trials (RCTs) have examined the effectiveness of pharmacologic agents and very few (and limited) RCTs have examined behavioral weight loss (BWL) to enhance weight losses following MBS. Thus, rigorous RCTs combining pharmacological and manualized BWL treatment to enhance weight outcomes after MBS is an imperative next step to reduce personal and public health costs of obesity. To help fill this critical gap in the MBS field, the proposed RCT will test the effectiveness of a rigorous manualized BWL and a FDA-approved weight-loss agent (naltrexone+bupropion/NB), alone and in combination, for improvements in weight loss, cardiovascular risk factors, and psychosocial functioning. N=160 patients with obesity (BMI≥30 or ≥27 with a medical comorbidity) who underwent MBS and have suboptimal weight outcomes will be randomly assigned (double-blind) in balanced factorial (2 X 2) design, to one of four 24-week conditions: BWL+NB, BWL+Placebo, NB-only (No BWL), or Placebo-only (No BWL). Outcome variables were determined based on the leading rigorous weight loss RCTs for obesity with NB, NIH ADOPT guidelines, and conceptually-relevant variables for NB and BWL. Independent outcome assessments will determine outcomes after discontinuation of treatments through 18 months. The proposed RCT will provide important new clinical findings regarding the utility and effectiveness of pharmacotherapy and BWL for a rapidly growing obesity subgroup and will inform care models for managing chronic obesity to enhance outcomes after MBS. This will be the first RCT to 1) test any pharmacologic treatment for obesity after MBS; 2) examine BWL and NB, alone and in combination, for weight loss and associated features in patients who have undergone MBS; and 3) examine the durability of treatment effects from combined treatment modalities by including long-term follow-up assessments after treatment delivery.

项目摘要。肥胖和严重肥胖率预计将继续上升到令人震惊的水平。到 2030 年，超过 51% 美国成年人预计将患有肥胖症，其中重度肥胖症患者将增加 130%。这些惊人的比率鉴于严重的疾病和经济负担，预计未来的增长令人深感担忧肥胖。随着严重肥胖率持续迅速上升，代谢和减肥手术 (MBS) 的使用越来越广泛预计会增加。 MBS 是治疗严重肥胖症最有效的方法，可产生令人印象深刻的急性肥胖症和长期减肥，以及改善医疗和心理社会合并症。然而，体重 MBS 后的结果明显不同，这表明仅手术对于相当大的患者来说是不够的。严重肥胖的亚组。 MBS 后体重反弹很常见，也是一个主要问题，特别是因为体重反弹与复发甚至恶化的医疗合并症有关。尽管需要由于肥胖的长期性和复发的风险，MBS 后持续的肥胖治疗几乎没有指导根据经验数据应提供哪些治疗。事实上，没有前瞻性研究或随机对照试验（RCT）已经检验了药物的有效性，但很少有（和有限的）随机对照试验研究了行为减肥 (BWL)，以增强 MBS 后的减肥效果。因此，严格的随机对照试验结合药理学和手动 BWL 治疗来改善体重结果 MBS 后的下一步是减少肥胖带来的个人和公共健康成本。为了帮助填补这个 MBS 领域的关键差距，拟议的 RCT 将测试严格的手动 BWL 和 FDA 批准的减肥药（纳曲酮+安非他酮/NB），单独或联合使用，可改善体重减轻、心血管危险因素和心理社会功能。 N=160 名肥胖患者（BMI≥30 或 ≥27 名患有医学合并症的人）接受 MBS 且体重结果不理想的人将被随机分组以平衡因子 (2 X 2) 设计分配（双盲）至四个 24 周条件之一：BWL+NB， BWL+安慰剂、仅 NB（无 BWL）或仅安慰剂（无 BWL）。结果变量的确定基于针对肥胖的领先严格减肥随机对照试验，符合 NB、NIH ADOPT 指南和概念相关性 NB 和 BWL 的变量。独立的结果评估将确定停药后的结果 18 个月的治疗次数。拟议的随机对照试验将提供有关以下方面的重要新临床发现：药物治疗和 BWL 对于快速增长的肥胖亚组的实用性和有效性，并将提供信息管理慢性肥胖的护理模型以改善 MBS 后的结果。这将是第一个随机对照试验 1) 测试 MBS 后针对肥胖症的任何药物治疗； 2) 单独或组合检查 BWL 和 NB，以了解接受 MBS 的患者体重减轻和相关特征； 3）检查耐久性综合治疗方式的治疗效果，包括治疗后的长期随访评估治疗交付。