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.
A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. The Behavioral Nudges for Diabetes Prevention (BEGIN) Trial will test two low-touch interventions designed to motivate adoption of these treatments to prevent diabetes. Given that 38% of U.S. adults have prediabetes, the proposed study has potential for large public health impact by testing pragmatic, scalable, and sustainable approaches based in primary care to promote evidence-based treatment for this common condition.
