Diabetes Mellitus, Type 2Phase 1/2NCT05905575
A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults
A Phase 1/2 study testing Family dyad diabetes intervention in people with Diabetes Mellitus, Type 2, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Family dyad diabetes intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individual with type 2 diabetes:
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
Official title: A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults With Type 2 Diabetes
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).
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Family dyad diabetes intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family dyad diabetes interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Family dyad diabetes intervention |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T1) to six months after intervention (T3) at month 11
Secondary outcomes (2)
Change in blood pressure control
Change in blood pressure will be measured with average scores of systolic and diastolic pressures.
Measured: 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.
Measured: Baseline (T1) to six months after intervention (T3) at month 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jun 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This two-arm randomized controlled trial (RCT) will test the feasibility, acceptability and efficacy of a family-dyad-focused intervention. A convenience sample will be recruited at clinics/pharmacy at Central Ohio. We will enroll a total of 208 participants in the study with104 African-Americans with T2D and one family member of each patient (104 patient-family member dyads). Patients with T2D will be randomized 1:1 to the intervention or control arm (n=52/arm). The family member of each patient will receive the same treatment as that assigned to the patient.
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905575
- Sponsor's protocol ID
- 2023 H0010
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 40706841
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05905575
- Acronym / sponsor ID
- 2023 H0010
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This two-arm randomized controlled trial (RCT) will test the feasibility, acceptability and efficacy of a family-dyad-focused intervention. A convenience sample will be recruited at clinics/pharmacy at Central Ohio. We will enroll a total of 208 participants in the study with104 African-Americans with T2D and one family member of each patient (104 patient-family member dyads). Patients with T2D will be randomized 1:1 to the intervention or control arm (n=52/arm). The family member of each patient will receive the same treatment as that assigned to the patient.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Family dyad diabetes interventionPatient-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 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family dyad diabetes interventionThe 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. | Behavioural | Intervention |
Primary outcome
Change in diabetes control
Time frame: Baseline (T1) to immediate post-intervention at month 5 (T2)
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.
Change in diabetes control
Time frame: Baseline (T1) to six months after intervention (T3) at month 11
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.
Change in health-related quality of life
Time frame: Baseline (T1) to immediate post-intervention at month 5 (T2)
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.
Change in health-related quality of life
Time frame: Baseline (T1) to six months after intervention (T3) at month 11
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.
2 secondary outcomes
Change in blood pressure control
Time frame: Baseline (T1) to immediate post-intervention at month 5 (T2)
Change in blood pressure control
Time frame: Baseline (T1) to six months after intervention (T3) at month 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 40706841Hu 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Family dyad diabetes intervention in people with Diabetes Mellitus, Type 2, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diabetes control (time frame: Baseline (T1) to immediate post-intervention at month 5 (T2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05905575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.