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)和二甲双胍是安全和 促进成人适度减肥和预防2型糖尿病(T2D)的有效治疗方案 有糖尿病前驱症状。然而，这些治疗方法在实践中很少使用，现有的研究也很少集中在 关于以患者为中心的方法，以促进它们的使用。一种潜在的方法，行为轻推，涉及 操纵健康信息和治疗选项，使行为改变更有可能和更容易实施。 虽然大量证据表明，行为督促是有效的，但它们并不是绝对有效的 研究了T2D的预防。我们将通过对以下方面进行行为推动来解决这一关键的知识差距 糖尿病预防(BEGIN)试验。拟议的研究将在初级保健诊所进行，其 前所未有的覆盖面和与糖尿病前期成年人的定期互动使这里成为翻译的理想环境 T2D预防研究。这项权威的研究将测试两种低接触干预措施：1)面对面干预 由旨在推动循证治疗的糖尿病前期决策辅助工具组成，并提供 由健康教育者；以及2)由励志信件和短信组成的自动干预， 传递类似的信息，并使用相同的行为提示。拟议的R18研究将完成 以下具体目标是确定促进最大限度治疗的最有效的低接触干预 领养和减肥。在目标1中，我们将让国家利益攸关方参与T2D预防，以最终确定和 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是一个务实的 临床级群集式随机对照试验检查面对面和自动化干预的减肥效果。 我们的完全析因设计允许我们测试每个干预措施，无论是单独的还是组合的，与通常的护理相比。这个 拟议的对984名患有糖尿病前期和超重/肥胖的初级保健患者的务实试验将估计 这些低接触干预措施对以下12个月结局的影响：体重变化(主要)和 采用ILI和/或二甲双胍(辅助)。体重和血红蛋白A1c从基线到24个月的变化 都被视为探索性结果。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中进行 保健中心，其中95%的糖尿病前期患者是少数民族，83%生活在贫困中。我们的 提案通过以下方式响应PAR-18-925：1)招募肩负着 T2D的负担不成比例，在临床研究中代表性不足；2)研究低接触干预 它们是真正务实的，具有巨大的可持续性和可扩展性潜力，我们的合作伙伴诊所 系统以前已经以某种形式使用过；3)利用现有人员和大量相关数据资源 T2D预防；以及4)与致力于继续 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.