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TOD Program for Type 2 Diabetes (TOD Trial)

N/A
Waitlist Available
Led By Melissa Walls, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ADULT: Are willing to complete all lessons and assessments
ADULT: Are willing to be randomly put into Group A (intervention) or Group B (waitlist control)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, month 3, month 6, month 12, month 18, and month 24
Awards & highlights

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.

Who is the study for?
This trial is for American Indian adult caregivers with type 2 diabetes and their children aged 10-16. Adults must be over 18, speak English, live near participating reservations, and have a confirmed diabetes diagnosis. Children must also speak English and be willing to participate in the study.Check my eligibility
What is being tested?
The 'Together Overcoming Diabetes' program is being tested. It's a family-based intervention delivered at home by health coaches over six months. Participants are randomly assigned to start immediately or after two years, with regular assessments of health outcomes.See study design
What are the potential side effects?
Since this is a behavioral intervention focusing on diabetes management rather than medication or medical procedures, there may not be direct side effects like those associated with drugs; however, lifestyle changes could potentially cause stress or require significant adjustments.

TOD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to complete all lessons and assessments.
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I am willing to be randomly assigned to a treatment or waitlist group.
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I can understand and sign forms and see well enough to complete tasks.
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I have a form from my doctor confirming my type 2 diabetes diagnosis.
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I can read, understand, and sign forms and complete tests by myself.
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I am between 10 and 16 years old.
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I live within 30 miles of a participating reservation.
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I am a caregiver to a child aged 10-16 living in my home.
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I am older than 18 years.
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I am willing to be randomly assigned to a treatment group.

TOD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, month 3, month 6, month 12, month 18, and month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, month 3, month 6, month 12, month 18, and month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Adult Participant Fasting HbA1c
Secondary outcome measures
Change in BMI/zBMI - Adult and Youth participants
Change in Depression and Depressive symptoms - Adult and Youth participants
Other outcome measures
Change in Communal Mastery - Adult and Youth participants
Change in Diabetes Empowerment - Adult participants
Change in Physical Activity - Adult and Youth participants

TOD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Together Overcoming Diabetes (TOD) curriculumExperimental Treatment1 Intervention
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.
Group II: Waitlist ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
408 Previous Clinical Trials
2,106,318 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,314,037 Total Patients Enrolled
Melissa Walls, PhDPrincipal InvestigatorJohns Hopkins University, Bloomberg School of Public Health

Media Library

Together Overcoming Diabetes (TOD) Clinical Trial Eligibility Overview. Trial Name: NCT04734015 — N/A
Type 2 Diabetes Research Study Groups: Waitlist Control, Together Overcoming Diabetes (TOD) curriculum
Type 2 Diabetes Clinical Trial 2023: Together Overcoming Diabetes (TOD) Highlights & Side Effects. Trial Name: NCT04734015 — N/A
Together Overcoming Diabetes (TOD) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04734015 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI
~43 spots leftby Apr 2025