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Ojibwe-Focused diabetes program aims to help families manage together

NCT ID NCT04734015

Disease control Sponsor: Johns Hopkins Bloomberg School of Public Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a culturally tailored program called Together Overcoming Diabetes (TOD) for American Indian families in Ojibwe communities. Adult caregivers with type 2 diabetes and their youth (ages 10-16) worked with local health coaches to set health goals. The program included 14 lessons delivered at home over 6 months, focusing on spiritual, mental, physical, and emotional wellness. Researchers tracked changes in blood sugar, weight, and other health measures for up to 2 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Together Overcoming Diabetes (TOD) program
What this could lead to
If it works, this could offer a culturally respectful way to help American Indian families better manage type 2 diabetes and prevent it in younger generations.
What could go wrong
This is a completed behavioral study with 162 participants, so results may not apply to all communities. The program is intensive (14 lessons over 6 months) and may be hard to sustain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

162 people

The number who actually took part.

Started

Jun 2021

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

  • Johns Hopkins University Great Lakes Hub

    Duluth, Minnesota, 55812, United States

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