Together Overcoming Diabetes - Great Plains

Официальное название

Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota

Обзор

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.

Вмешательства

• Поведенческое TOD 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 ove
• Поведенческое Waitlist Standard of Care
  Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Первичные конечные точки

• Glycated hemoglobin (HbA1c) [Срок оценки: Baseline, 3 months, 6 months, and 12 months]

Критерии участия

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Center for Indigenous Health - Great Plains Hub — Rapid City

Идентификаторы

NCT: NCT06770673 · IRB00029399 · OT2HL158287

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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