Together Overcoming Diabetes - Great Plains

Johns Hopkins Bloomberg School of Public Health

Status: Enrolling

Conditions: Diabetes

Treatments: Behavioral: Waitlist Standard of Care; Behavioral: TOD Great Plains

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06770673

OT2HL158287 (U.S. NIH Grant/Contract)

IRB00029399

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups, including a placebo group

Together Overcoming Diabetes Intervention

Experimental group

Description:

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

Treatment:

Behavioral: TOD Great Plains

Waitlist Standard of Care

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Waitlist Standard of Care