Trial and Participant Characteristics of a Home-Visiting Diabetes Intervention: The Together Overcoming Diabetes Study.

Background: American Indians (AIs) endure the most severe health inequities in the nation, including disproportionately high rates of Type 2 diabetes (T2D). We describe baseline characteristics for AI participants enrolled in a culturally grounded, intergenerational, home-based T2D preventive intervention called Together Overcoming Diabetes (TOD). Methods: This community-based participatory research collaboration between five tribal nations and university-based researchers launched recruitment for a waitlist randomized control trial (RCT) design in 2021. Eligible participants were adults diagnosed with T2D who self-identified as AI, lived on or near participating reservations, and were caregivers to youth aged 10-16 years. Participants completed baseline assessments upon enrollment before being randomized to the intervention or waitlist group. Results: A total of N = 162 individuals (81 adults and 81 youth) enrolled in the study. Most of the adult (Indigenous) sample reported being female (77.8%) and were on average 49.5 years old. Average age of youth participants was 13.2 years, with similar representation of girls and boys. Mean adult HbA1c (primary outcome for the trial) was 7.93 (SD = 1.99) at baseline. Around 19% of youth participants reported a T2D or prediabetes diagnosis. Additional demographic and holistic health results are presented. Conclusion: This study provides comprehensive information about physiological, psychological, behavioral, and sociodemographic characteristics for a sample of AI families enrolled in a T2D intervention study. Findings suggest that intervention goals to improve behaviors like diet and physical activity are warranted and highlight the need for policy changes to address the social determinants of health. Trial Registration: ClinicalTrials.gov identifier: NCT04734015.