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: 10617234
• 负责人: Aaron S Kelly
• 金额: $ 65.53万
• 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/10617234
• 关键词: Adherence; Adolescent; Adolescent obesity; Adverse event; Age; Agonist; Behavior Therapy; Behavioral; Biological; Body Weight decreased; Body fat; Body mass index; Clinical; Clinical Practice Guideline; Clinical Trials; Combination Drug Therapy; 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; Patients; Pharmacotherapy; Physiological; Population; Prevalence; Process; Quality of life; Randomized; Recommendation; Refractory; Reporting; Resistance; Resources; Risk Factors; Safety; Services; System; Time; Uncertainty; United States Preventative Services Task Force; Update; Weight maintenance regimen; Youth; adolescent patient; arm; behavior change; bone health; cardiometabolic risk; compare effectiveness; cost; cost effective; cost effectiveness; gastrointestinal; implementation evaluation; improved; increased appetite; liraglutide; maladaptive behavior; moderate obesity; pediatric patients; primary outcome; psychosocial; randomized, clinical trials; 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.

摘要 青少年严重肥胖症的患病率在美国处于历史最高水平(~8%)，其顽固性 这种疾病的发生导致了关于如何提供有效、安全、可扩展和持久的治疗的不确定性 而不会给医疗体系带来不必要的压力。2017年，美国预防服务工作组 (USPSTF)发布了最新的筛查建议，结论是全面、密集的行为 在2-12个月的时间里，总共接触≥26个小时的干预措施导致患有 肥胖，≥52接触小时导致更大的体重减轻和一些心脏代谢的改善 风险因素。然而，向数百万人提供这些类型的密集行为服务的实用性 在美国对患有严重肥胖症的年轻人的研究存在争议，这不仅是因为 严重肥胖，而且这种方法的时间承诺、可接受性和可持续性对患者和 他们的家庭和提供这些干预所需的广泛资源。虽然行为改变是一种 任何有效减肥方法的不可或缺的组成部分，辅助策略，如 药物治疗可能会改善健康状况。药物治疗结合相对低强度治疗 行为咨询(26个接触小时)代表了一种潜在的有效、持久和安全的治疗方法 针对这一人群的战略。这种方法可能更实际和更可行，以便在广泛范围内实施， 更受患者和家属青睐，使用的医疗资源更少，提供服务的成本比 全面、密集的行为干预。我们提出了一项双臂随机临床试验。 严重肥胖的青少年对两年来全面、密集的行为咨询进行评估， 与USPSTF报告保持一致(第一年52个接触小时；第二年26个接触小时)，而不是第二年 多年使用利拉鲁肽和相对低强度的行为咨询进行医疗管理(12次接触 第一年为六个小时；第二年为六个小时)。结果将包括减肥效果和 耐用性、心脏代谢危险因素改善、生活质量、安全性和实施可行性。