NCT04734015Completed
Together Overcoming Diabetes
Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 162 (actual)
- First submitted
- 25 Jan 2021
- Start date
- 18 Jun 2021
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Diseases
- Type 2 diabetes
- NCT number
- NCT04734015
What you commit to
- Study type: Interventional
- Participants enrolled: 162
- From 18 Jun 2021 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- No confirmed type 2 diabetes diagnosis
- Has comorbidity(ies) that may have an impact on type 2 diabetes management
- YOUTH
Age
- Not a caregiver to a youth ages 10-16 in their home
- Do not fall within the specified age range of 10-16 years at time of enrollment
Other
- ADULTS (target participants)
- Are not American Indian
- Does not live within the distance inclusion criteria
- Is unable to complete the study procedures
- Are not American Indian
- Do not have an enrolled Adult caregiver
- Unable to read and speak English
- Not willing to complete the study procedures
Who the study is looking for
- 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)
Age in the registry: 10 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Great Lakes Hub Coordinator of this site? Confirm its status | Duluth | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.