The Integrating Cultural Aspects Into Diabetes Education(INCLUDE) Study to Prevent Diabetes in Chinese Immigrants:Protocol for a Randomized Controlled Trial

Background: Type 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the UnitedStates, exacerbated by social determinants of health (SDOH) barriers such as language barriers, limited access to healthy foods,and low health literacy.Objective: The goal of the Integrating Cultural Aspects into Diabetes Education (INCLUDE) study is to test a social media-basedintervention adapting the Diabetes Prevention Program (DPP) for Chinese immigrants alongside a culturally adapted,community-supported agriculture program. Here, we report the protocol for the INCLUDE study.Methods: INCLUDE is a 3-year randomized controlled trial (n=150). Participants with prediabetes or at risk for T2D are enrolledand randomized into either the control or intervention group (n=75 each). Participants from the intervention group receive 2-3culturally tailored, in-language DPP videos weekly for 12 weeks, as well as biweekly phone calls from bilingual study staff toreview video content, support goal setting, and assess and address SDOH-related barriers such as food insecurity. Interventionparticipants will also be given produce for 10 weeks as part of the community-supported agriculture program. Weight (primaryoutcome), self-efficacy, diet, physical activity, and food insecurity (secondary outcomes) are measured at baseline, 3-month, and6-month intervals. Splined linear mixed models will be used to examine group differences in longitudinal weight and othersecondary outcomes. The INCLUDE study was approved by the Institutional Review Board at the NYU Grossman School ofMedicine.Results: Recruitment started in May 2023, with the first cohort of 75 participants enrolled and randomized into 2 groups in July2023. The 3-month and 6-month assessment of the first-year cohort has been completed. We have recruited 75 participants forthe second cohort as of July 2024.Conclusions: The INCLUDE study will serve as an innovative model for culturally adapted, multilevel interventions forunderserved communities previously unable to access evidence-based diabetes prevention initiatives. Aligning with severa national calls for multilevel interventions, the INCLUDE intervention will provide critical data that will inform how researchersand public health professionals address SDOH barriers faced by underserved populations and prevent diabetes