A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults
1 other identifier
interventional
208
1 country
1
Brief Summary
A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) in African American adults with type 2 diabetes (T2D).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus-type-2
Started Jun 2023
Longer than P75 for phase_1 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
March 5, 2026
March 1, 2026
3.7 years
April 18, 2023
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Change in diabetes control
Change in glycosylated hemoglobin A1c will be measured with finger stick blood with a glycosylated hemoglobin A1CNow+ test. Changes in average percent of A1c will be used in the study.
Baseline (T1) to immediate post-intervention at month 5 (T2)
Change in diabetes control
Change in glycosylated hemoglobin A1c will be measured with finger stick blood with a glycosylated hemoglobin A1CNow+ test. Changes in average percent of A1c will be used in the study.
Baseline (T1) to six months after intervention (T3) at month 11
Change in health-related quality of life
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) will be used to measure changes in total scores of the global physical and global mental health. Scores range from 0-100 with higher scores indicating better quality of life.
Baseline (T1) to immediate post-intervention at month 5 (T2)
Change in health-related quality of life
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) will be used to measure changes in total scores of the global physical and global mental health. Scores range from 0-100 with higher scores indicating better quality of life.
Baseline (T1) to six months after intervention (T3) at month 11
Secondary Outcomes (2)
Change in blood pressure control
Baseline (T1) to immediate post-intervention at month 5 (T2)
Change in blood pressure control
Baseline (T1) to six months after intervention (T3) at month 11
Study Arms (2)
Intervention
EXPERIMENTALPatient-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.
Control
NO INTERVENTIONAll 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.
Interventions
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
You may qualify if:
- Individual with type 2 diabetes:
- Self-identification as African American;
- 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.
You may not qualify if:
- Individual with T2D and family members:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University College of Nursing
Columbus, Ohio, 43210, United States
Related Publications (1)
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.
PMID: 40706841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2023
First Posted
June 15, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.
- Access Criteria
- Requests will be reviewed by the project investigators (PI). In accordance with NIH policies and procedures regarding data use and data sharing, user registration will be required to access the les. Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistributions of the data to third parties, and proper acknowledgement of the data resource. Any presentations, abstracts, or publications must include an acknowledgement/reference of the research team. The requesting researcher(s) will be notified that they may only use the data for the purposes for which the data were requested and only by the individuals listed in the request. The requesting researcher(s) will be responsible for notifying the PI upon completion of analysis indicating the way the data were destroyed.
Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. All research data will be shared as requested in accordance with federal regulations, the Freedom of Information Act (FOIA). Requests from researchers will be reviewed by the project investigators, and we will provide the requesting researcher with the minimum necessary data; the shared data will not have any individual participant identifiers or specific clinic identifiers.