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: 10216252
• 负责人: Angela Fidler Pfammatter
• 金额: $ 56.83万
• 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 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10216252
• 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 肥胖的高流行率导致死亡率停滞不前，医疗保健支出增加， 就业和低工资。目前的黄金标准治疗是昂贵和负担，限制 大多数公众都能接触到，对这场公共卫生危机几乎没有影响。了很多种尝试 已作出改善交付成功的糖尿病预防计划（DPP），显示产生 6个月内平均减重6.5公斤。然而，迄今为止的研究缺乏系统的 继续优化DPP治疗包，导致包中缺少重要部分 对患者来说是负担，或者不产生足够的体重减轻。拟议的工作代表了 在一个有效的，系统的过程中的下一步，以确定积极的治疗成分，目标是 组装能够以降低的成本和负担产生足够的重量减轻的治疗包。我们 之前的试验Opt-IN是一项高效、充分把握度的全因子随机试验，旨在检验主要 附加处理组分的作用和相互作用（例如，短信，代餐），当 增加自我监测、心理教育、饮食和身体活动目标的最低限度干预， 两周一次的辅导电话结果支持，可以从最小的 没有额外组件的干预水平。一个值得注意的发现表明，24教练 接受12次治疗并不比接受12次治疗更好，大大降低了干预的潜在成本。 虽然Opt-IN试验的目的是测试组件的贡献，但一个完整的头对头随机 需要在新优化的干预措施（EVO： 治疗肥胖）和当前的黄金标准DPP。此外，全面的经济分析，使用并发 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。目的1是测试减肥是否 从基线到6个月，EVO实现的非劣效于DPP。目标2将侧重于进行全面的 经济评价符合现行准则。最后，探索性目标将调查减肥 12个月时的维护以及自我调节的变化，调节器（即，年龄、性别、社会经济 状态）和介体（即，自我监测依从性、自我效能）。