A diabetes intervention program for American Indian and Alaska Native populations

Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota

This study tests a special diabetes program designed for American Indian and Alaska Native adults to see if it helps them manage their diabetes better than standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 10 Years and up
• Sex: All
• Sponsor: Johns Hopkins Bloomberg School of Public Health (Academic / other)
• Locations: 1 site (Rapid City, South Dakota)
• Trial ID: NCT06770673 on ClinicalTrials.gov

What this trial studies

This research evaluates the Together Overcoming Diabetes (TOD) intervention, specifically designed to address the unique risk factors and social determinants affecting diabetes in American Indian and Alaska Native populations. The program aims to provide tailored support and resources to improve diabetes management among participants. It includes a randomized approach where some participants receive the TOD intervention while others are placed on a waitlist for standard care. The study focuses on adult individuals who self-identify as American Indian or Alaska Native and reside near the Oyate Health Center.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who self-identify as American Indian or Alaska Native and have a confirmed diagnosis of Type 2 Diabetes.

Not a fit: Patients who are unable to participate fully in the intervention or evaluation due to personal circumstances or advanced disease conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve diabetes management and health outcomes for American Indian and Alaska Native populations.

How similar studies have performed: Other studies targeting diabetes interventions in similar populations have shown promise, indicating that culturally tailored approaches can lead to improved health outcomes.

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).

Where this trial is running

Rapid City, South Dakota

• Center for Indigenous Health - Great Plains Hub — Rapid City, South Dakota, United States (Recruiting)

Study contacts

• Principal investigator: Donald Warne, MD, MPH — Johns Hopkins University
• Study coordinator: Courtney Claussen, PhD

Conditions Diabetes