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TOD Program for Type 2 Diabetes (TOD Trial)
TOD Trial Summary
This trial is testing a culturally tailored, family-based type 2 diabetes management and preventive intervention for American Indian adult caregivers and their youth aged 10-16. Adult/youth participant dyads will be enrolled across 5 Ojibwe tribal communities and will be randomized into one of two groups: Group A will begin the intervention program immediately, and Group B (the waitlist) will begin the intervention program in 2 years. The 14-lesson intervention program will be delivered in the participant's home by local Family Health Coaches over a 6-month period.
TOD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTOD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TOD Trial Design
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Who is running the clinical trial?
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- I am willing to complete all lessons and assessments.You identify yourself as American Indian.I can understand and sign forms and see well enough to complete tasks.I am willing to be randomly assigned to a treatment or waitlist group.I have a form from my doctor confirming my type 2 diabetes diagnosis.I am a young participant without an adult caregiver enrolled in the study.I can read, understand, and sign forms and complete tests by myself.I am between 10 and 16 years old.I have other health issues that could affect my diabetes management.I am not between the ages of 10 and 16.I live within 30 miles of a participating reservation.I cannot follow the study's required procedures.I am not responsible for a child aged 10-16 in my home.I am a caregiver to a child aged 10-16 living in my home.I am not willing to follow the study's required procedures.I am older than 18 years.I am willing to be randomly assigned to a treatment group.I do not have type 2 diabetes.
- Group 1: Waitlist Control
- Group 2: Together Overcoming Diabetes (TOD) curriculum
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants is this experiment recruiting?
"Accurately, clinicaltrials.gov evidence confirms that this medical experiment, originally posted on June 18th 2021, is actively recruiting individuals. Approximately 300 participants are needed from 1 distinct research site."
Are there opportunities to join this experiment currently available?
"Affirmative. Information available on clinicaltrials.gov shows that this research, initially posted June 18th 2021, is actively searching for participants to join the trial. 300 people are needed to take part in this study at one medical centre."
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