Status:

ACTIVE_NOT_RECRUITING

Together Overcoming Diabetes

Lead Sponsor:

Johns Hopkins Bloomberg School of Public Health

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

10+ years

Phase:

NA

Brief Summary

Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention. Participants in this trial are American Indian adult caregivers diagn...

Detailed Description

Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention. The program activates family and cultural practices that encourage hea...

Eligibility Criteria

Inclusion

  • ADULT (target participants)
  • Are greater than 18 years of age
  • Self-identify as American Indian
  • Have a completed verification form from a healthcare provider indicating a confirmed diagnosis of type 2 diabetes
  • Live on or within 30 miles of participating reservations
  • Are a caregiver to a 10-16 year-old who lives in their home
  • Are willing to be randomly put into Group A (intervention) or Group B (waitlist control)
  • Are willing to complete all lessons and assessments
  • Speak and read English
  • Are not cognitively or visually impaired (able to review and sign informed consent and complete assessments)
  • YOUTH
  • 10 -16 years of age
  • Self-identify as American Indian
  • Live with an adult who has joined the study
  • Are willing to be randomly put into Group A or Group B
  • Are willing to complete all lessons and assessments
  • Speak and read English
  • Are not cognitively or visually impaired (able to review and sign informed consent and complete assessments)

Exclusion

  • ADULTS (target participants)
  • Are not American Indian
  • No confirmed type 2 diabetes diagnosis
  • Not a caregiver to a youth ages 10-16 in their home
  • Does not live within the distance inclusion criteria
  • Is unable to complete the study procedures
  • Has comorbidity(ies) that may have an impact on type 2 diabetes management
  • YOUTH
  • Are not American Indian
  • Do not fall within the specified age range of 10-16 years at time of enrollment
  • Do not have an enrolled Adult caregiver
  • Unable to read and speak English
  • Not willing to complete the study procedures

Key Trial Info

Start Date :

June 18 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2026

Estimated Enrollment :

162 Patients enrolled

Trial Details

Trial ID

NCT04734015

Start Date

June 18 2021

End Date

June 1 2026

Last Update

May 4 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Johns Hopkins University Great Lakes Hub

Duluth, Minnesota, United States, 55812