Comparison of Intensive Behavioral Counseling vs. Medical Management to Treat Adolescent Severe Obesity

强化行为咨询与药物治疗治疗青少年严重肥胖的比较

• 批准号: 10215501
• 负责人: Aaron S Kelly
• 金额: $ 65.94万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10215501
• 关键词: Address; Adherence; Adolescent; Adolescent obesity; Adverse event; Advisory Committees; Age; Agonist; Behavior; Behavior Therapy; Behavioral; Biological; Body Weight decreased; Body fat; Body mass index; Clinical; Clinical Practice Guideline; Clinical Trials; Counseling; Development; Disease; Effectiveness; Enrollment; Family; Food; GLP-I receptor; Health; Healthcare; Healthcare Systems; Homeostasis; Hormones; Hour; Individual; Intervention; Medical; Mental Health; Morbid Obesity; Nature; Obesity; Outcome; Outcome Assessment; Palate; Patients; Pharmacotherapy; Physiological; Population; Prevalence; Preventive service; Process; Quality of life; Randomized; Randomized Clinical Trials; Recommendation; Refractory; Reporting; Resistance; Resources; Risk Factors; Safety; Services; System; Time; Uncertainty; Update; Weight maintenance regimen; Youth; adherence rate; adolescent patient; arm; base; behavior change; bone health; cardiometabolic risk; compare effectiveness; cost; cost effective; cost effectiveness; gastrointestinal; increased appetite; liraglutide; moderate obesity; pediatric patients; primary outcome; psychosocial; safety outcomes; screening guidelines; success; treatment strategy

Abstract The prevalence of adolescent severe obesity is at an all-time high in the U.S. (~8%), and the refractory nature of this disease has led to uncertainty regarding how to provide effective, safe, scalable, and durable treatments without placing undue strain on the healthcare system. In 2017, the U.S. Preventive Services Task Force (USPSTF) released updated screening recommendations concluding that comprehensive, intensive behavioral interventions with a total of ≥26 contact hours over a period of 2-12 months resulted in weight loss in youth with obesity, with ≥52 contact hours leading to even greater weight loss and improvements in some cardiometabolic risk factors. However, the practicality of delivering these types of intensive behavioral services to the millions of youth with severe obesity in the U.S. is debatable not only because of the treatment-resistant nature of severe obesity, but also the time-commitment, acceptability, and sustainability of this approach for patients and their families and the extensive resources required to offer these interventions. While behavior change is an indispensable component of any effective weight loss approach, adjunctive strategies such as pharmacotherapy may enhance health outcomes. Pharmacotherapy combined with relatively low-intensity behavioral counseling (<26 contact hours) represents a potentially effective, durable, and safe treatment strategy for this population. This approach may be more practical and feasible to implement on a broad scale, preferred by patients and families, utilize fewer healthcare resources, and cost less to deliver compared to comprehensive, intensive behavioral interventions. We propose a two-arm, randomized clinical trial in adolescents with severe obesity evaluating two years of comprehensive, intensive behavioral counseling, aligned with the USPSTF report (52 contact hours during year one; 26 contact hours during year two), vs. two years of medical management with liraglutide plus relatively low-intensity behavioral counseling (12 contact hours during year one; six contact hours during year two). Outcomes will include weight loss effectiveness and durability, cardiometabolic risk factor improvements, quality of life, safety, and implementation feasibility.

抽象的 在美国，青春期严重肥胖症的患病率在历史悠久（约8％）和难治性 这种疾病导致有关如何提供有效，安全，可扩展和耐用的治疗的不确定性 而不会使医疗保健系统施加不满。 2017年，美国预防服务工作队 （USPSTF）发布的更新的筛选建议得出结论，全面，密集的行为 在2-12个月内，总共≥26个接触小时的干预措施导致年轻人的体重减轻 肥胖，≥52个接触小时，导致某些心脏代谢的体重减轻和改善更大 风险因素。但是，向数百万美元提供此类强化行为服务的实用性 美国有严重肥胖症的青年不仅是有争议的 严重的肥胖症，以及这种方法对患者的时间承诺，可接受性和可持续性以及 他们的家人和提供这些干预措施所需的大量资源。而行为改变是 任何有效的减肥方法的必不可少的组成部分，辅助策略，例如 药物疗法可以增强健康结果。药物治疗与相对较低的强度结合 行为咨询（<26个接触时间）代表一种潜在的有效，耐用且安全的治疗 该人群的策略。这种方法可能更实用和可行，可以大规模实施， 与患者和家庭相比，患者和家人更喜欢医疗保健资源，而交付的成本更低 全面，密集的行为干预措施。我们提出了一项两臂的随机临床试验 严重肥胖的青少年评估了两年的全面，密集的行为咨询， 与USPSTF报告一致（第一年的52个接触时间；第二年的26个接触时间），而两个 Liraglutide以及相对较低强度的行为咨询（12联系） 第一年的小时；第二年的六个接触时间）。结果将包括减肥效率和 持续时间，心脏代谢风险因素改善，生活质量，安全性和实施可行性。