Together Overcoming Diabetes (NCT04734015) | Clinical Trial Compass
CompletedNot Applicable
Together Overcoming Diabetes
United States162 participantsStarted 2021-06-18
Plain-language summary
Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention.
Participants in this trial are American Indian adult caregivers diagnosed with type 2 diabetes and their youth, aged 10-16 years at enrollment. Adult/youth participant dyads will be enrolled across 5 Ojibwe tribal communities. Consenting participant dyads will be randomized into one of two groups:
Group A: begin the intervention program immediately; Group B (waitlist): begin the intervention program in 2 years.
Both groups will complete assessments with study staff at baseline, 3, 6, 12, 18, and 24 months to assess HbA1c, cholesterol, blood pressure (adults), biometric measures, and psychosocial and behavioral outcomes (adults and youth).
The 14-lesson intervention program will be delivered in the participant's home by local Family Health Coaches over a 6-month period.
Upon completion of the intervention, participants may also be invited to participate in a "Ripple Effects Mapping" (REM) session for discussions, and mapping of the intervention effects.
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 caregi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is called 'Together Overcoming Diabetes' and measured changes in HbA1c through fasting — can you tell me what kind of program or intervention was involved, and whether an approach like this might be realistic for managing my own blood sugar levels?
2Since this trial has already been completed, has the data been published or shared anywhere, and what did the results actually show about whether HbA1c improved for participants?
3This study didn't have a traditional phase, which often means it was more of a behavioral or program-based intervention rather than a drug trial — does that change how you'd weigh its findings compared to medication-based options for someone in my situation?
4HbA1c is one important marker, but are there other factors my care team would want to track alongside it — like weight, blood pressure, or kidney function — that this trial may not have focused on?
5Given that enrollment is now closed, are there similar ongoing programs or studies you'd recommend I look into, or would sticking with my current treatment plan be a better first step?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Adult Participant Fasting HbA1c
Timeframe: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Trial details
NCT IDNCT04734015
SponsorJohns Hopkins Bloomberg School of Public Health