Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care

项目摘要 大型随机试验发现，强化生活方式干预（ILI）和二甲双胍是安全的， 促进成人适度减肥和预防2型糖尿病（T2 D）的有效治疗选择 糖尿病前期然而，这些治疗方法很少在实践中使用，现有的研究很少关注 以病人为中心的方法来促进他们的使用。一个潜在的方法，行为助推，涉及到 操纵健康信息和治疗方案，使行为改变更有可能和更容易实施。 虽然大量的证据表明，行为助推是有效的，但它们并没有得到明确的证实。 研究T2 D预防。我们将通过开展以下行为推动活动来解决这一关键的知识差距： 糖尿病预防（开始）试验。拟议的研究将在初级保健诊所进行， 前所未有的接触和与糖尿病前期成人的定期互动使其成为翻译的理想环境。 T2 D预防研究。这项确定性的研究将测试两种低接触干预：1）亲自干预 包括糖尿病前期决策辅助，旨在推动循证治疗的采用， 由健康教育工作者; 2）自动干预，包括激励性信件和短信， 传递相似的信息并使用相同的行为推动。拟议的R18研究将完成 以下具体目标，以确定最有效的低接触干预，促进最大限度的治疗 收养和减肥。在目标1中，我们将让国家利益攸关方参与T2 D预防， 集成自动化干预组件，以实现最大的可持续性和可扩展性。目标2是务实的 临床水平的随机对照试验（RCT）检查了面对面和自动干预的减肥效果。 我们的全析因设计允许我们测试每一种干预措施，无论是单独还是组合，与常规护理相比。的 一项针对984名糖尿病前期和超重/肥胖的初级保健患者的实用试验将估计 这些低接触干预对以下12个月结果的影响：体重变化（主要）和 采用ILI和/或二甲双胍（次要）。体重和血红蛋白A1 c自基线至24个月的变化 作为探索性结果进行检查。目标3使用混合方法来检查拟议的干预措施 覆盖范围、采用、实施、维护和成本。这项研究将在一个大型社区进行 该中心95%的糖尿病前期患者是少数民族，83%的人生活在贫困中。我们 建议通过以下方式响应PAR-18-925：1）招募一个脆弱的研究人群， T2 D负担不成比例，在临床研究中代表性不足; 2）研究低接触干预措施 真正务实、具有可持续性和可扩展性的巨大潜力，并且我们的合作伙伴诊所 系统以前已经以某种形式使用过; 3）利用现有的工作人员和大量的相关数据资源 T2 D预防;以及4）与经验丰富的临床合作伙伴合作， 在研究期之后实施拟议的干预措施。

Project Summary Large randomized trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for promoting modest weight loss and preventing type 2 diabetes (T2D) among adults with prediabetes. However, these treatments are rarely used in practice, and little existing research has focused on patient-centered approaches for promoting their use. One potential approach, behavioral nudges, involves manipulating health messages and treatment options to make behavior change more likely and easier to enact. While a large body of evidence suggests that behavioral nudges are effective, they have not been definitively studied for T2D prevention. We will address this critical knowledge gap by conducting the Behavioral Nudges for Diabetes Prevention (BEGIN) Trial. The proposed study will take place in primary care clinics, whose unprecedented reach and regular interaction with prediabetic adults make this an ideal setting for translational T2D prevention research. This definitive study will test two low-touch interventions: 1) In-person intervention consisting of a prediabetes decision aid designed to nudge uptake of evidence-based treatments and delivered by health educators; and 2) Automated intervention consisting of motivational letters and text messages that deliver similar information and use the same behavioral nudges. The proposed R18 study will accomplish the following specific aims to determine the most effective low-touch intervention that promotes maximal treatment adoption and weight loss. In Aim 1, we will engage national stakeholders in T2D prevention to finalize and integrate the automated intervention components for maximal sustainability and scalability. Aim 2 is a pragmatic clinic-level cluster RCT examining the weight loss effectiveness of the in-person and automated interventions. Our full factorial design allows us to test each intervention, both individually and combined, vs. usual care. The proposed pragmatic trial of 984 primary care patients with prediabetes and overweight/obesity will estimate the effects of these low-touch interventions on the following 12-month outcomes: change in weight (primary) and adoption of ILI and/or metformin (secondary). Change in weight and hemoglobin A1c from baseline to 24 months are examined as exploratory outcomes. Aim 3 uses mixed methods to examine the proposed interventions' reach, adoption, implementation, maintenance, and cost. This study will be conducted in a large community health center, in which 95% of patients with prediabetes are racial/ethnic minorities and 83% live in poverty. Our proposal is responsive to PAR-18-925 by: 1) recruiting a vulnerable study population that shoulders a disproportionate burden of T2D and is underrepresented in clinical research; 2) studying low-touch interventions that are truly pragmatic, that have great potential for sustainability and scalability, and that our partner clinic system has already used in some form before; 3) leveraging existing staff and substantial data resources related to T2D prevention; and 4) collaborating with an experienced clinical partner that is committed to continued implementation of the proposed interventions beyond the study period.