The INtegrating CuLtUral aspects into Diabetes Education (INCLUDE) study: protocol for a multi-level, mHealth-based intervention to prevent diabetes in Chinese immigrants

Background: Type 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the United States, exacerbated by social determinants of health (SDOH) such as language barriers, limited access to healthy foods, or low health literacy. Objective: The goal of the INtegrating CuLtUral aspects into Diabetes Education (INCLUDE) study is to test a social media-based intervention adapting the Diabetes Prevention Program (DPP) for Chinese immigrants alongside a culturally adapted community-supported agriculture (CSA) program. We report the protocol for the INCLUDE study. Methods: INCLUDE is a three-year randomized controlled trial (n=150). Participants with prediabetes or at risk for T2D are enrolled and randomized into either the control or intervention group (n=75 each). Participants from the intervention group receive 2-3 culturally tailored, in-language DPP videos weekly for 12 weeks, and biweekly phone calls from bilingual study staff to review video content, support goal setting, and to assess and address SDOH-related barriers such as food insecurity. Intervention participants will also be given produce for 10 weeks as part of the CSA program. Weight (primary outcome), self-efficacy, diet, physical activity, and food insecurity (secondary outcomes) are measured at baseline, 3-month, and 6-month intervals. Splined linear mixed models will be used to examine group differences in longitudinal weight and other secondary outcomes. The INCLUDE study was approved by the Institutional Review Board at the NYU Grossman School of Medicine. Trial registration: This study was registered at ClinicalTrials.gov (NCT05492916; registered 08/09/2022). Discussion: The INCLUDE study will serve as an innovative model for culturally adapted multi-level interventions for underserved communities previously unable to access evidence-based diabetes prevention initiatives. Aligning with several national calls for multi-level interventions, the INCLUDE intervention will provide critical data that will inform how researchers and public health professionals address SDOH barriers faced by underserved populations and prevent diabetes.