Together Overcoming Diabetes (TOD)
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Family Intervention, Lifestyle Intervention, Indigenous, American Indian, Native American
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- Johns Hopkins University Great Lakes Hub
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Together Overcoming Diabetes (TOD) curriculum
Waitlist Control
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD). Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months. Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.