Type 2 Diabetes Clinical Trial
Official title:
Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention. Participants in this trial are American Indian adult caregivers diagnosed with type 2 diabetes and their youth, aged 10-16 years at enrollment. Adult/youth participant dyads will be enrolled across 5 Ojibwe tribal communities. Consenting participant dyads will be randomized into one of two groups: Group A: begin the intervention program immediately; Group B (waitlist): begin the intervention program in 2 years. Both groups will complete assessments with study staff at baseline, 3, 6, 12, 18, and 24 months to assess HbA1c, cholesterol, blood pressure (adults), biometric measures, and psychosocial and behavioral outcomes (adults and youth). The 14-lesson intervention program will be delivered in the participant's home by local Family Health Coaches over a 6-month period. Upon completion of the intervention, participants may also be invited to participate in a "Ripple Effects Mapping" (REM) session for discussions, and mapping of the intervention effects.
Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention. The program activates family and cultural practices that encourage healthy diets and physical activities, promotes coping skills for dealing with stress, and reconnects families via a home-based intervention taught by American Indian (AI) paraprofessional Family Health Coaches. Evaluation of TOD for this trial will happen via Community Based Participatory Research (CBPR). The study team will enroll "target" adult caregivers diagnosed with type 2 diabetes and their youth, ages 10-16 years at enrollment, with the goal of tapping motivational reciprocity between the two generations. The work involves collaboration with five Ojibwe tribal communities in the midwestern U.S. to implement a randomized controlled study with a wait-list design respectful of cultural norms of inclusion. The study will evaluate effectiveness of the intervention on adult physiological (primary outcome = HbA1c), behavioral, and mental health and children's psychosocial, familial, behavioral and physiological risk and protective factors for diabetes. The research will also identify stress-coping mechanisms that mediate the impact of the intervention on health. A novel collaborative, qualitative evaluation technique will map potential "ripple effects" of the intervention within families and communities. If effective, the intervention will promote dissemination and scaling with tribal health coaches, community involvement, and stakeholder (health providers, health and human service agencies) input. ;
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