Diabetes Risk Education and Communication Trial (DiRECT) for Primary Care Patients with Prediabetes

The overall goal of this R34 proposal is to investigate how individuals’ perceived risk of developing diabetes, and a novel intervention to communicate diabetes risk, impact treatment decisions among adult patients with prediabetes. Despite promising evidence that supports using metformin and intensive lifestyle intervention (ILI) for diabetes prevention among high-risk individuals, these treatments have not yet entered routine clinical practice. In response, national stakeholders in diabetes prevention have focused on building public awareness about prediabetes and T2D risk without evidence that this approach will promote treatment uptake. A large body of research in risk communication has shown variable effects of interventions on treatment adherence and disease-specific outcomes. However, none of these studies have focused on risk communication related to prediabetes or diabetes prevention. Our proposed study aims to generate evidence about how individuals’ perceived diabetes risk, and communicating evidence-based diabetes risk information to them, influences the decision to adopt ILI or metformin. This project will take place in large safety-net community health centers, which are understudied yet important settings for diabetes prevention research given the vulnerable populations they serve with a high burden of diabetes risk. In Aim 1 of the proposed research, we will develop a novel intervention to communicate diabetes risk to adults with prediabetes using materials that we have already developed and pilot tested in the target population. This intervention will be delivered by medical assistants, who are ubiquitous in community health centers and represent a large primary care workforce with untapped potential. In Aim 2 of this study, we will evaluate the effects of this novel intervention on patients’ perceived risk of developing diabetes, in addition to other relevant endpoints that may impact their decision to adopt treatment. In Aim 3, we will conduct a pilot pragmatic trial of 80 adult patients with prediabetes that estimates preliminary effects of the novel risk communication on the following 3-month outcomes: initiation of ILI and/or metformin (primary); adherence to these treatment(s); and weight loss The results of this study will help our team prepare for a definitive pragmatic trial testing the impact of our novel risk communication intervention on treatment adherence and relevant biomarkers (weight and hemoglobin A1c). Throughout the proposed research, we will engage a group of local practitioners, content experts, and national stakeholders to maximize the sustainability and scalability of our novel intervention.