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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 not cognitively or visually impaired (able to review and sign informed consent and complete assessments)
ADULT: Have a completed verification form from a healthcare provider indicating a confirmed diagnosis of type 2 diabetes
Must not have
YOUTH: Do not have an enrolled Adult caregiver
YOUTH: Do not fall within the specified age range of 10-16 years at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, month 3, month 6, month 12, month 18, and month 24
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the TOD program, which helps American Indian families manage type 2 diabetes through home-based coaching on healthy living. It targets adults with diabetes and their children, aiming to improve their health by promoting good habits and reducing stress. The Together on Diabetes (TOD) program was developed through community-based participatory research and has been tested in multiple studies involving American Indian youth and their families.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a young participant without an adult caregiver enrolled in the study.
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I am not between the ages of 10 and 16.
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I cannot follow the study's required procedures.
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I do not have type 2 diabetes.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Type 2 Diabetes include education, lifestyle modification, and family support. Education empowers patients with knowledge about their condition and management strategies, which is crucial for adherence to treatment plans. Lifestyle modification, including dietary changes and increased physical activity, helps improve insulin sensitivity and glycemic control, reducing the need for medication. Family support provides emotional and practical assistance, enhancing the patient's ability to maintain healthy behaviors. These non-pharmacologic approaches are foundational because they address the root causes of hyperglycemia and can significantly improve long-term outcomes. Pharmacologic treatments, such as metformin, work by decreasing hepatic glucose production and improving insulin sensitivity, while other medications like SGLT2 inhibitors and GLP1 receptor agonists help lower blood glucose levels through different mechanisms. Combining these strategies can lead to better overall management of Type 2 Diabetes.

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
424 Previous Clinical Trials
2,123,722 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,429 Previous Clinical Trials
4,322,652 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
~18 spots leftby Apr 2025