Together Overcoming Diabetes
Completed · Not applicable
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT04734015
- Run by
- Johns Hopkins Bloomberg School of Public Health
- People needed
- 162
- Starts
- 2021-06-18
- Expected to finish
- 2025-10-11
- Last updated by the study team
- 2026-06-16
Who can join
Age: 10 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ADULT (target participants)
- Are greater than 18 years of age
- Self-identify as American Indian
- Have a completed verification form from a healthcare provider indicating a confirmed diagnosis of type 2 diabetes
- Live on or within 30 miles of participating reservations
- Are a caregiver to a 10-16 year-old who lives in their home
- Are willing to be randomly put into Group A (intervention) or Group B (waitlist control)
- Are willing to complete all lessons and assessments
- Speak and read English
- Are not cognitively or visually impaired (able to review and sign informed consent and complete assessments)
- YOUTH
- 10 -16 years of age
- Self-identify as American Indian
- Live with an adult who has joined the study
- Are willing to be randomly put into Group A or Group B
- Are willing to complete all lessons and assessments
- Speak and read English
- Are not cognitively or visually impaired (able to review and sign informed consent and complete assessments)
You may not qualify if…
- ADULTS (target participants)
- Are not American Indian
- No confirmed type 2 diabetes diagnosis
- Not a caregiver to a youth ages 10-16 in their home
- Does not live within the distance inclusion criteria
- Is unable to complete the study procedures
- Has comorbidity(ies) that may have an impact on type 2 diabetes management
- YOUTH
- Are not American Indian
- Do not fall within the specified age range of 10-16 years at time of enrollment
- Do not have an enrolled Adult caregiver
- Unable to read and speak English
- Not willing to complete the study procedures
Where it is running
- Johns Hopkins University Great Lakes Hub — Duluth, Minnesota, United States
Full record on ClinicalTrials.gov
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