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Recruiting

NCT Number: NCT06770673

Together Overcoming Diabetes - Great Plains

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.

Recruiting

Interested in participating?

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Indigenous Health - Great Plains Hub

Rapid City, South Dakota, 57701, United States

Location status: Recruiting

Location contact

Courtney Claussen, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Glycated hemoglobin (HbA1c)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Claussen, PhD

CONTACT

[email protected]

605-200-0043

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Oyate Health Center
  • The NIH Community Engagement Alliance

Registry information

Official study title

Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 13, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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