Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2025-03-11
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Together Overcoming Diabetes Intervention
Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families
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.
Waitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Waitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Interventions
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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.
Waitlist Standard of Care
Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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
* Cognitively or visually impaired
* Youth in foster care (due to potential mobility of foster youth).
10 Years
ALL
No
Sponsors
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The NIH Community Engagement Alliance
UNKNOWN
Oyate Health Center
UNKNOWN
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Donald Warne, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Center for Indigenous Health - Great Plains Hub
Rapid City, South Dakota, United States
Countries
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Central Contacts
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Facility Contacts
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Courtney Claussen, PhD
Role: primary
Other Identifiers
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IRB00029399
Identifier Type: -
Identifier Source: org_study_id
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