The ADELANTE Trial: Testing a multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes - PROJECT SUMMARY Hispanic households in the United States disproportionately experience food insecurity (22%). Food insecurity, defined as the lack of access to safe, affordable, and health-promoting foods, presents a challenge for effective management of nutrition-sensitive chronic conditions such as prediabetes and diabetes. This is especially distressing for Hispanic adults with prediabetes and diabetes, given that food insecurity is associated with worse glycemic control. Food is Medicine, the integration of nutrition programs with healthcare, holds promise for addressing the dual challenge of food insecurity and diabetes management. The goal of ADELANTE (Addressing Diabetes by ELevating Access to Nutrition: A Trial of Effectiveness) is to determine whether a Food is Medicine intervention to improve household food insecurity and glycemic control is effective for Hispanic patients with prediabetes or diabetes. We will use a type 1 hybrid trial to assess the effectiveness of the Food is Medicine 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 of HbA1c at 6 months, as well as key secondary outcomes, such as HbA1c at 12 months and diabetes-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 and dietary behaviors. 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, and a 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 Hispanic population, at La Clínica de La Raza, a community clinic with multiple locations throughout Alameda County. Successful completion of these aims will provide evidence of the effectiveness of a Food is Medicine program for improving household food insecurity and glycemic control among Hispanic adults with prediabetes or diabetes and their household members.
