Together Overcoming Diabetes - Great Plains

Part of paid clinical trials in Rapid City, South Dakota.

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT06770673
Status
Recruiting
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Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TOD Great Plains — BEHAVIORAL
    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 — BEHAVIORAL
    Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Study Details

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.

Key Dates

Start date
Mar 11, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Together Overcoming Diabetes Intervention
    Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families
  • Placebo Comparator: Waitlist Standard of Care
    Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Primary Outcome Measure

Glycated hemoglobin (HbA1c) [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Indigenous Health - Great Plains HubRapid CitySouth Dakota57701
Courtney Claussen, PhD

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Center for Indigenous Health - Great Plains Hub· Rapid City, SD

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