Evaluating the EVO treatment optimized for resource constraints: Elements Vital to treat Obesity

评估针对资源限制优化的 EVO 治疗：治疗肥胖的重要要素

• 批准号: 10437676
• 负责人: Angela Fidler Pfammatter
• 金额: $ 58.7万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10437676
• 关键词: Address; Adherence; Age; American; Behavior Therapy; Behavioral; Body Weight Changes; Body Weight decreased; Calories; Church; Clinical; Clinical Trials; Communities; Data; Development; Diet; Dissemination and Implementation; Elements; Employment; Excision; Fatty acid glycerol esters; Future; Goals; Gold; Guidelines; Head; Health Care Costs; Healthcare; High Prevalence; Individual; Informal Social Control; Intervention; Kilogram; Maintenance; Mediator of activation protein; Monitor; Motivation; Obesity; Participant; Patients; Persons; Physical activity; Policies; Population; Prevalence; Process; Public Health; Quality of life; Randomized Controlled Trials; Reading; Reporting; Research; Research Design; Research Personnel; Resources; Self Efficacy; Socioeconomic Status; Specific qualifier value; Testing; Text Messaging; Treatment Cost; Wages; Work; Workplace; active method; base; cost; cost effectiveness; cost estimate; cost-effectiveness evaluation; design; diabetes prevention program; economic evaluation; effectiveness evaluation; head-to-head comparison; improved; intervention cost; mobile application; mortality; multiphase optimization strategy; obesity treatment; preservation; primary outcome; programs; psychoeducation; randomized trial; remote delivery; sex; smartphone Application; standard care; standard of care; success; telephone coaching; treatment effect; treatment optimization; treatment program; trial design; weight loss intervention; weight loss program

PROJECT SUMMARY High prevalence of obesity contributes to stagnant mortality rates, increased health care spending, decreased employment, and lower wages. Current gold standard treatments are costly and burdensome, limiting accessibility to the majority of the public and having little effect on this public health crisis. Many attempts have been made to improve the delivery of the successful Diabetes Prevention Program (DPP), shown to produce an average of 6.5kg weight loss over 6 months. However, research to date has lacked a systematic optimization of the DPP treatment package, resulting in packages that have essential parts missing, continue to be burdensome for the patient, or do not produce enough weight loss. The proposed work represents the next step in an efficient, systematic process to identify active treatment components with the goal of assembling a treatment package that can produce sufficient weight loss at a reduced cost and burden. Our prior trial, Opt-IN, was a highly efficient, fully powered full factorial randomized trial designed to test main effects and interactions of additional treatment components (e.g., text messages, meal replacements), when added to a minimal intervention of self-monitoring, psychoeducation, diet and physical activity goals, and biweekly coaching calls. The results supported that significant weight loss could be attained from a minimal level of intervention with no additional components. One notable finding demonstrated that 24 coaching sessions was no better than receiving 12 sessions, significantly reducing potential cost of an intervention. While the Opt-IN trial was designed to test contribution of components, a full head-to-head randomized controlled trial will need to be conducted between the newly optimized intervention (EVO: Elements Vital to treat Obesity) and the current gold standard DPP. Furthermore, full economic analyses that use concurrent clinical trial data from weight loss treatments is lacking, and as such, we intend to do so to inform future dissemination, implementation, and/or further optimization of treatments. Aim 1 is to test whether weight loss from baseline to 6 months achieved by EVO is non-inferior to DPP. Aim 2 will focus on conducting a full economic evaluation consistent with current guidelines. Finally, exploratory aims will investigate weight loss maintenance at 12 months as well as change in self-regulation, moderators (i.e., Age, Sex, Socioeconomic status) and mediators (i.e., self-monitoring adherence, self-efficacy) of treatment effects.

项目摘要 肥胖症的高患病率导致死亡率停滞，医疗保健支出增加，减少 就业和较低的工资。当前的黄金标准治疗费用昂贵且繁重，限制 可访问大多数公众，对这一公共卫生危机的影响很小。许多尝试都有 已成为改善成功的糖尿病预防计划（DPP）的交付 平均在6个月内减肥6.5公斤。但是，迄今为止的研究缺乏系统 优化DPP处理套件，导致丢失必不可少零件的包装，继续 对于患者来说是负担重的，或者不能产生足够的体重减轻。拟议的工作代表 下一步以高效，系统的过程，以识别活跃的治疗成分的目标 组装一个可以减轻成本和负担，可以产生足够的体重减轻的治疗套件。我们的 先前的试验选择加入是一项高效，完全动力的完整阶乘随机试验，旨在测试主试验 当效果和相互作用的其他治疗组件（例如，文本消息，更换膳食）的效果和相互作用 除了对自我监控，心理教育，饮食和体育锻炼目标的最小干预以及 双周的教练电话。结果支持从最小的 干预水平，没有其他组件。一个值得注意的发现证明了24个教练 会议并不比接受12个课程更好，从而大大降低了干预的潜在成本。 虽然选择加入试验旨在测试组件的贡献，但正面的正面随机分组 对照试验将需要在新优化的干预措施之间进行（EVO：至关重要的要素 治疗肥胖）和当前的金标准DPP。此外，使用并发的全面经济分析 缺乏减肥治疗的临床试验数据，因此，我们打算这样做以告知未来 传播，实施和/或进一步优化治疗。目标1是测试是否减肥 EVO从基线到6个月，不在DPP中。 AIM 2将重点进行全面 经济评估与当前指南一致。最后，探索目标将调查减肥 在12个月以及自我调节，主持人（即年龄，性别，社会经济）的维护 状态）和介体（即自我监控的依从性，自我效能感）。