Together Overcoming Diabetes - Great Plains
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TOD Great Plains, Waitlist Standard of Care.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota
Overview
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
- 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 ove - Behavioral Waitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Primary outcome measures
- Glycated hemoglobin (HbA1c) [Time frame: Baseline, 3 months, 6 months, and 12 months]
Eligibility criteria
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.
Exclusion Criteria - Youth Support Participants:
- Cognitively or visually impaired
- Youth in foster care (due to potential mobility of foster youth).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Center for Indigenous Health - Great Plains Hub — Rapid City
Identifiers
NCT: NCT06770673 · IRB00029399 · OT2HL158287