Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota

Johns Hopkins Bloomberg School of Public Health1 site in 1 country140 target enrollmentMarch 11, 2025

ConditionsDiabetes

InterventionsWaitlist Standard of Care TOD Great Plains

Overview

Phase: Not Applicable
Intervention: Waitlist Standard of Care
Conditions: Diabetes
Sponsor: Johns Hopkins Bloomberg School of Public Health
Enrollment: 140
Locations: 1
Primary Endpoint: Glycated hemoglobin (HbA1c)
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 11, 2025

End Date

October 1, 2028

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johns Hopkins Bloomberg School of Public Health

Responsible Party

Sponsor

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.