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

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. A large body of evidence suggests that risk communication interventions are a promising method for motivating patients to adopt diverse preventive health behaviors. However, the effects of risk communication have not been definitively studied for prediabetes and T2D prevention. We plan to address this critical knowledge gap by conducting the Diabetes Risk Education and Communication Trial (DiRECT). 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 interventions: 1) In-person risk communication by medical assistants using a decision aid that displays information about prediabetes and T2D prevention; and 2) Automated risk communication via motivational letters and text messages that deliver similar content. The proposed R18 study will accomplish the following specific aims to determine the most effective risk communication approach that promotes maximal treatment adoption and weight loss. In Aim 1, we will engage national stakeholders in T2D prevention to integrate the automated risk communication components for maximal sustainability and scalability. Aim 2 is a pragmatic clinic-level cluster RCT examining the weight loss effectiveness of in-person and automated risk communication interventions. Our full factorial design allows us to test the effectiveness of each intervention (i.e. in-person and automated risk communication) both individually and combined. The proposed pragmatic trial of 1,304 primary care patients with prediabetes and overweight/obesity will estimate the effects of these 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 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 interventions that are truly pragmatic, that have great potential for sustainability and scalability, and that our partner clinic system already uses; 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 in practice.