A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults
NCT ID: NCT05905575
Last Updated: 2025-10-01
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
PHASE1/PHASE2
208 participants
INTERVENTIONAL
2023-06-01
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Patient-family member dyads in the family dyad intervention arm will receive 1) 10 sessions (8 weekly and 2 biweekly) over 12 weeks of family-dyad-focused, virtual group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.
Family dyad diabetes intervention
The goals of the intervention are to encourage participants to (1) daily self-manage diabetes and stress; (2) establish a healthy eating pattern; (3) engage in brisk walking of 150 or more minutes a week; and (4) use solution-focused problem-solving strategy and supportive family communication skills.
Control
All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study.
No interventions assigned to this group
Interventions
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Family dyad diabetes intervention
The goals of the intervention are to encourage participants to (1) daily self-manage diabetes and stress; (2) establish a healthy eating pattern; (3) engage in brisk walking of 150 or more minutes a week; and (4) use solution-focused problem-solving strategy and supportive family communication skills.
Eligibility Criteria
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Inclusion Criteria
* Self-identification as African American;
* 40 years or older
* Type 2 diabetes diagnosis for at least six months;
* A1c \> 7.0% at time of enrollment;
* Being able to speak and read English;
* Being able to walk;
* Having an adult family member/close friend willing to co-participate in the study.
Family members:
* Adults (18 years or older, with or without T2D);
* Residing in the same household as the T2D participants;
* Being a spouse, adult child or sibling; or close friend
* Being able to walk;
* Being able to speak and read English.
Exclusion Criteria
* Being pregnant or have an advanced or terminal condition;
* Being cognitively impaired or unable to provide informed consent;
* Lack conclusive evidence of T2D for patients with T2D.
18 Years
90 Years
ALL
Yes
Sponsors
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Ohio State University
OTHER
Responsible Party
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Locations
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The Ohio State University College of Nursing
Columbus, Ohio, United States
Countries
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References
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Hu J, Mion LC, Tan A, Bartle-Haring S, Miller C, Joseph JJ. Family dyad-focused diabetes self-management intervention (FDSMI) for African American adults with type 2 diabetes: Study protocol. Contemp Clin Trials. 2025 Sep;156:108029. doi: 10.1016/j.cct.2025.108029. Epub 2025 Jul 22.
Other Identifiers
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2023 H0010
Identifier Type: -
Identifier Source: org_study_id
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