Together Overcoming Diabetes - Great Plains
NCT06770673 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2026-01-23
Summary
The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.
Conditions
Interventions
- BEHAVIORAL
-
TOD Great Plains
The adapted TOD intervention is rooted in the original TOD structure, delivery system, and home-visiting teaching schedule. Local enhancements include intervention topics and activities to address local adult caregivers' diabetes management and to promote families' modifiable risk and protective factors targeted by this proposal and informed by the Wicozani wellness concept and measurement. The TOD intervention includes targeted content taught approximately bi-weekly by family health coaches over a 16-week period.
- BEHAVIORAL
-
Waitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Sponsors & Collaborators
-
The NIH Community Engagement Alliance
collaborator UNKNOWN -
Oyate Health Center
collaborator UNKNOWN -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Johns Hopkins Bloomberg School of Public Health
lead OTHER
Principal Investigators
-
Donald Warne, MD, MPH · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-11
- Primary Completion
- 2027-07-31
- Completion
- 2028-10-31
Countries
- United States
Study Locations
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