A Phase 1/2 interventional study of Family dyad diabetes intervention in Diabetes Mellitus, Type 2, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Ohio State University · Phase 1/2, Interventional, and Treatment
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).
Eligible participants and their family members will be randomly assigned to either the intervention and control group. Patient-family-member dyads in the intervention arm will virtually receive 1) 10 session over 12 weeks of family dyad-focused, 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. All participants will be assessed at baseline, post-intervention and six months after intervention.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 208 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individual with type 2 diabetes:
Family members:
Exclusion Criteria:
Individual with T2D and family members:
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.
Behavioral: Family dyad diabetes intervention
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T1) to six months after intervention (T3) at month 11
Change in blood pressure control
Change in blood pressure will be measured with average scores of systolic and diastolic pressures.
Time frame: Baseline (T1) to immediate post-intervention at month 5 (T2)
Change in blood pressure control
Change in blood pressure will be measured with average scores of systolic and diastolic pressures.
Time frame: Baseline (T1) to six months after intervention (T3) at month 11
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Ohio State University