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ACTIVE NOT RECRUITING
NCT04734015
NA

Together Overcoming Diabetes

Sponsor: Johns Hopkins Bloomberg School of Public Health

View on ClinicalTrials.gov

Summary

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.

Official title: Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities

Key Details

Gender

All

Age Range

10 Years - Any

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2021-06-18

Completion Date

2026-06-01

Last Updated

2026-02-02

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Together Overcoming Diabetes (TOD)

Curriculum approaches health through a holistic lens of spiritual, mental, physical and emotional wellness. American Indian Family Health Coaches conduct motivational interviewing to help participant dyads (adult caregivers with Type 2 diabetes and their youth) set attainable goals and work through obstacles to reach those goals.

Locations (1)

Johns Hopkins University Great Lakes Hub

Duluth, Minnesota, United States