The EVO study protocol for a randomized controlled evaluation trial of an optimized weight management intervention.

The EVO study protocol for a randomized controlled evaluation trial of an optimized weight management intervention.
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DOI:
10.1016/j.cct.2022.106750
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发表时间:
2022-05
影响因子:
2.2
通讯作者:
Chang, Su-Hsin
Chang, Su-Hsin
中科院分区:
医学4区
文献类型:
--
作者:
Pfammatter, Angela Fidler;Battalio, Samuel L.;Olvera, Charlie;DeZelar, Margaret;Moore, Dominique;Scanlan, Laura;Siddique, Juned;Spring, Bonnie;Chang, Su-Hsin

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肥胖是一个重大的公共卫生问题;然而,肥胖症的黄金标准行为治疗成本高昂且负担重。有效的糖尿病预防计划 (DPP) 的现有调整结果好坏参半。我们之前的研究将多阶段优化策略 (MOST) 应用于 DPP,确定了一种更简约、成本更低的干预措施 (EVO),可以显着减轻体重。远程进行的 EVO 试验的目的是测试 EVO 相对于 DPP 的非劣效性。我们将在试验的同时进行经济评估,以估计 EVO 与 DPP 相比的交付和患者成本、成本效益以及终身医疗保健成本。探索性分析将检查治疗效果的维持、调节和调节因素。 EVO 试验将在全国范围内随机招募 524 名肥胖参与者。参与者将在 6 个月内收到 EVO 或 DPP。 EVO 参与者将获得在线课程、用于自我监控饮食、体力活动和体重的智能手机应用程序,并参加与健康促进专家的 12 次简短通话。 DPP 参与者将收到疾病控制中心前 6 个月的 T2D 材料,并与经过 DPP 交付认证的工作人员参加 16 个一小时的视频通话会议。将在基线、3 个月、6 个月和 12 个月时测量体重。将收取分项送货费用。工作人员和参与者还将提供信息来估算干预相关活动的成本。 EVO 试验可以建立证据支持传播可扩展的、具有成本效益的行为治疗方法,有可能改变临床实践指南、为政策提供信息并降低肥胖的患病率。
Obesity is a substantial public health concern; however, gold-standard behavioral treatments for obesity are costly and burdensome. Existing adaptations to the efficacious Diabetes Prevention Program (DPP) demonstrate mixed results. Our prior research applying the Multiphase Optimization Strategy (MOST) to DPP identifies a more parsimonious, less costly intervention (EVO) resulting in significant weight loss. The aim of the remotely conducted EVO trial is to test the non-inferiority of EVO against DPP. We will conduct economic evaluations alongside the trial to estimate delivery and patient costs, cost-effectiveness, and lifetime healthcare costs of EVO as compared to DPP. Exploratory analyses will examine maintenance, moderators, and mediators of the treatment effect. The EVO trial will recruit nationally to randomize 524 participants with obesity. Participants will receive either EVO or DPP over a 6 month period. EVO participants will be provided online lessons, a smartphone application to self-monitor diet, physical activity, and weight, and attend 12 brief calls with a Health Promotionist. DPP participants will receive the first 6 months of the Center for Disease Control’s T2D materials and attend 16 one-hour video call sessions with staff certified in DPP delivery. Weight will be measured at baseline, 3-, 6-, and 12-months. Itemized delivery cost will be collected. Staff and participants will also provide information to estimate costs for intervention-related activities. The EVO trial could establish evidence supporting dissemination of a scalable, cost-effective behavioral treatment with potential to shift clinical practice guidelines, inform policy, and reduce the prevalence of obesity.
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