The ADELANTE Trial: Testing a multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes - PROJECT SUMMARY Latinos account for the largest share of SARS-CoV-2 (COVID-19) cases (60%) and deaths (48%) compared to any other racial/ethnic group in California. Additionally, Latino households have experienced a dramatic increase in household food insecurity due to the pandemic. This is especially distressing for Latinos with type 2 diabetes (T2DM) as household food insecurity is associated with worse glycemic control, which has life- threatening consequences during the COVID-19 pandemic. T2DM, and especially poorly controlled T2DM, is a risk factor for death from COVID-19. Effective multilevel interventions to improve household food insecurity and glycemic control are urgently needed for Latinos with diabetes to mitigate disparities due to COVID-19. The goal of ADELANTE (Addressing Diabetes by ELevating Access to Nutrition: A Trial of Effectiveness) is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes. We will use a type 1 hybrid trial to assess the effectiveness of the multilevel intervention on the primary outcome of glycemic control (HbA1c) at 6 months. Participants (n=355) will be randomized to either: 1) 12 weeks of household deliveries of fiber-rich foods (vegetables, beans/legumes, and whole grains) plus a 12-month remotely delivered, culturally-adapted lifestyle behavioral intervention called Vida Sana, or 2) a waitlist control arm, receiving the intervention after a 6-month delay. We will follow participants for 12 months to assess the primary outcome ofHbA1c at 6 months as well as key secondary outcomes such as HbA1c at 12 months, and diabetes- and COVID-related stress at 6 and 12 months. Additionally, we will recruit up to 2 household members for each participant to assess household-level secondary outcomes such as household food insecurity, dietary behaviors, and COVID-related stress. To assess the future potential of implementation and dissemination of the multilevel intervention in primary care we will use mixed methods including quantitative measures (e.g., intervention dose and fidelity) and qualitative interviews with participants and key stakeholders (e.g., providers, clinic leadership, community supported agricultural group) according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. We will involve patients and our longstanding community partners in all phases of the trial. The trial will take place in Alameda County, California, which is home to a large and diverse Latino population, at La Clínica de La Raza, a community safety net clinic with multiple locations throughout Alameda County. Successful completion of these aims will provide robust evidence of the effectiveness of improving household food insecurity and glycemic control among Latinos with diabetes during the pandemic.
