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: 10033189
• 负责人: Angela Fidler Pfammatter
• 金额: $ 55.05万
• 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/10033189
• 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; 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; sex; smartphone Application; standard care; standard of care; success; 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.

项目概要 肥胖率高导致死亡率停滞不前、医疗保健支出增加、死亡率下降 就业，工资较低。目前的黄金标准治疗方法昂贵且繁重，限制了 大多数公众都可以使用，但对这场公共卫生危机影响甚微。很多尝试都有 旨在改善成功的糖尿病预防计划 (DPP) 的实施，事实证明， 6个月内平均减重6.5公斤。但迄今为止的研究还缺乏系统的 优化 DPP 处理包，导致包中缺少重要部件，继续 给患者带来负担，或者不能产生足够的减肥效果。拟议的工作代表了 下一步是采用高效、系统的流程来确定活性治疗成分，其目标是 组装一个治疗包，可以以降低的成本和负担产生足够的减肥效果。我们的 之前的试验 Opt-IN 是一项高效、功能齐全的全析因随机试验，旨在测试主要 额外治疗成分（例如短信、代餐）的效果和相互作用，当 添加自我监控、心理教育、饮食和身体活动目标的最低限度干预，以及 每两周一次的辅导电话。结果表明，通过最少的摄入量就可以实现显着的减肥效果。 无需额外组件的干预水平。一项值得注意的发现表明，24 会议并不比接受 12 次会议更好，从而显着降低了干预的潜在成本。 虽然 Opt-IN 试验旨在测试成分的贡献，但完整的头对头随机试验 需要在新优化的干预措施之间进行对照试验（EVO：Elements Vital to 治疗肥胖）和当前的黄金标准 DPP。此外，使用并发的完整经济分析 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 治疗的传播、实施和/或进一步优化。目的1是测试是否减肥 EVO 实现的从基线到 6 个月的时间不劣于 DPP。目标 2 将侧重于开展全面的 经济评估符合现行指南。最后，探索性目标将调查减肥 12 个月时的维持以及自我调节、调节因素（即年龄、性别、社会经济）的变化 状态）和治疗效果的中介因素（即自我监测依从性、自我效能）。