Diabetes
Conditions
Brief 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.
Interventions
BEHAVIORALTOD 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.
BEHAVIORALWaitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Sponsors
Johns Hopkins Bloomberg School of Public Health
The NIH Community Engagement Alliance
Oyate Health Center
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Independent Evaluators are masked to the study participants' randomized group status/
Intervention model description
Waitlist randomized control trial
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adult Index Participants: * 18 years and older * Self-identifies as American Indian or Alaska Native * Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center * Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test. * Caregiver to a 10- to 25-year-old in their home at the time of screening. * Willing to complete all implementation and follow-up assessments. * Willing to be randomized for the intervention.
Exclusion criteria
- Adult Index Participants: * Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.) * Willing to serve as 'support person' for the adult participant. * Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation Inclusion Criteria - Youth Support Participants: * Between 10 years and 25 years old * Self-identifies as American Indian or Alaska Native. * Willing to serve as 'support person' for the adult participant. * Willing to complete all implementation and follow-up assessments. * Willing to be randomized for the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin (HbA1c) | Baseline, 3 months, 6 months, and 12 months | Glycated hemoglobin as measured by a point-of-care A1c test |
Countries
United States
Contacts
CONTACTCourtney Claussen, PhD
PRINCIPAL_INVESTIGATORDonald Warne, MD, MPH
Johns Hopkins University
Outcome results
None listed