Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
162 participants
INTERVENTIONAL
2021-06-18
2026-06-01
Brief Summary
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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.
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Detailed Description
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Evaluation of TOD for this trial will happen via Community Based Participatory Research (CBPR). The study team will enroll "target" adult caregivers diagnosed with type 2 diabetes and their youth, ages 10-16 years at enrollment, with the goal of tapping motivational reciprocity between the two generations. The work involves collaboration with five Ojibwe tribal communities in the midwestern U.S. to implement a randomized controlled study with a wait-list design respectful of cultural norms of inclusion.
The study will evaluate effectiveness of the intervention on adult physiological (primary outcome = HbA1c), behavioral, and mental health and children's psychosocial, familial, behavioral and physiological risk and protective factors for diabetes. The research will also identify stress-coping mechanisms that mediate the impact of the intervention on health. A novel collaborative, qualitative evaluation technique will map potential "ripple effects" of the intervention within families and communities. If effective, the intervention will promote dissemination and scaling with tribal health coaches, community involvement, and stakeholder (health providers, health and human service agencies) input.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The intervention group will receive the 6-month intervention and 6-month maintenance phase immediately; the wait-list will receive standard care for 24 months and will then receive the intervention.
TREATMENT
DOUBLE
Study Groups
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Together Overcoming Diabetes (TOD) curriculum
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.
Together Overcoming Diabetes (TOD)
Curriculum approaches health through a holistic lens of spiritual, mental, physical and emotional wellness. American Indian Family Health Coaches conduct motivational interviewing to help participant dyads (adult caregivers with Type 2 diabetes and their youth) set attainable goals and work through obstacles to reach those goals.
Waitlist Control
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.
No interventions assigned to this group
Interventions
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Together Overcoming Diabetes (TOD)
Curriculum approaches health through a holistic lens of spiritual, mental, physical and emotional wellness. American Indian Family Health Coaches conduct motivational interviewing to help participant dyads (adult caregivers with Type 2 diabetes and their youth) set attainable goals and work through obstacles to reach those goals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
Exclusion Criteria
* Are not American Indian
* No confirmed type 2 diabetes diagnosis
* Not a caregiver to a youth ages 10-16 in their home
10 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Melissa Walls, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University, Bloomberg School of Public Health
Locations
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Johns Hopkins University Great Lakes Hub
Duluth, Minnesota, United States
Countries
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References
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Walls ML, Sittner KJ, Gomez GJ, Cole RE, Perkins SR, Steinberg RI, Forsberg AK, Haroz EE, Barlow A. Trial and Participant Characteristics of a Home-Visiting Diabetes Intervention: The Together Overcoming Diabetes Study. J Diabetes Res. 2025 Apr 24;2025:6591307. doi: 10.1155/jdr/6591307. eCollection 2025.
Other Identifiers
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IRB00010045
Identifier Type: OTHER
Identifier Source: secondary_id
DK091250
Identifier Type: -
Identifier Source: org_study_id
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