The overall goal of this R03 proposal is to develop an effective and potentially scalable intervention to prevent diabetes in people with elevated depressive symptoms (EDS) and prediabetes. This study focuses on Latinos, a demographic group at particularly high risk for these related conditions. Experience from the Diabetes Prevention Program (DPP), and related translational studies, suggests that the evidence-based DPP lifestyle intervention is less effective among depressed individuals. Many studies link depressive symptoms with incident diabetes, yet no studies have attempted to treat depressive symptoms in prediabetic adults as part of a diabetes prevention strategy. The proposed Promotora Intervention for Metabolic and Mental Health (PRIME2) will be the first adaptation of the DPP lifestyle intervention to simultaneously address depressive symptoms and prediabetes in a program delivered by promotoras, or community health workers. In Phase 1, the investigators will develop the PRIME2 intervention, which integrates proven principles from cognitive-behavioral therapy into existing materials based on the DPP. The proposed intervention includes 18 group-based sessions led by a promotora in Spanish over 6 months. Phase 2 involves a mixed-methods evaluation of PRIME2. Phase 2A is a pilot randomized trial of PRIME2 vs. usual care (UC), which will be followed by participant focus groups and individual interviews with promotoras delivering PRIME2 in Phase 2B. This qualitative evaluation will develop a deeper understanding of the intervention’s acceptability and effects prior to a full-scale study of PRIME2. The target population is Latino adults with EDS and prediabetes (n=40, 20 in each arm). We hypothesize that: 1) PRIME2 participants will have greater weight loss and improvement in cardiometabolic markers (waist circumference and hemoglobin A1C) compared to UC; and 2) PRIME2 participants will experience a greater reduction in depressive symptoms (based on the Beck Depression Inventory) than UC participants. All data from this pilot study will be used to develop a novel clinical trial exploring the interface between depressive symptoms and metabolic health among Latinos at-risk for comorbid depression and diabetes.
|Effective start/end date||2/1/17 → 1/31/19|
- National Institute of Diabetes and Digestive and Kidney Diseases (5R03DK109243-02)