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RecruitingNCT06770673Updated Jan 23, 2026

Together Overcoming Diabetes - Great Plains

An interventional study of TOD Great Plains and Waitlist Standard of Care in Diabetes, sponsored by Johns Hopkins Bloomberg School of Public Health. Recruiting at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 140 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Together Overcoming Diabetes Intervention

    Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families

    Behavioral: TOD Great Plains

  • Placebo comparator
    Waitlist Standard of Care

    Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

    Behavioral: Waitlist Standard of Care

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.

06

What researchers measure

Primary outcomes

  1. Glycated hemoglobin (HbA1c)

    Glycated hemoglobin as measured by a point-of-care A1c test

    Time frame: Baseline, 3 months, 6 months, and 12 months

07

Study locations

1 of 1 sites recruiting
  • Center for Indigenous Health - Great Plains Hub
    Rapid City, South Dakota 57701, United States
    • Courtney Claussen, PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06770673
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
The NIH Community Engagement Alliance, Oyate Health Center, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Jan 13, 2025
Start date
Mar 11, 2025
Primary completion
Jul 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Jan 23, 2026

Study contacts

Courtney Claussen, PhD
Contact
cclauss1@jh.edu
605-200-0043
Donald Warne, MD, MPH
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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