Type 2 DiabetesFDSMEFBONCT04256486
Family Model Diabetes Self-Management Education in Faith Based Organizations
A study testing Family Model Diabetes Self-Management Education and Support in people with Type 2 Diabetes, run by University of Arkansas at 1 site in United States.
Trial summary
This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Family Model Diabetes Self-Management Education and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 22 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-reported Marshallese
- 18 years of age or older
- have T2D (defined as having an HbA1c equal to or greater than 6.5)
- have at least one family member willing to take part
Who cannot join
- has received DSME in the past five years
- has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
- plans to move out of the geographic region
Trial locations and contacts
1 site in 1 country.
United States1 site
UAMS Institute for Community Health Innovation
Springdale, Arkansas, 72762
About this study
This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.
- Conditions
- Type 2 Diabetes
- Being tested
- Family Model Diabetes Self-Management Education and Support
- Keywords
- Family Model, Marshallese, Pacific Islander, Diabetes Education
- 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 Model Diabetes Self-Management Education and SupportBehavioural
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.
| Study group | Role | What they receive |
|---|---|---|
| Family DSMES | Experimental | Not described Receives: Behavioral: Family Model Diabetes Self-Management Education and Support |
| Wait List | Experimental | Not described Receives: Behavioral: Family Model Diabetes Self-Management Education and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points
Measured by Change in Adjusted Mean HbA1c(%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, and 24 Months Post-intervention.
Measured: Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start21 Apr 2022
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Pearl McElfish, Phd, MDA, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256486
- Sponsor's protocol ID
- 229034
- Other IDs
- 1R01MD013852-01
- Acronym
- FDSMEFBO
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2020
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Model Diabetes Self-Management Education in Faith Based Organizations
- ClinicalTrials.gov ID
- NCT04256486
- Acronym / sponsor ID
- FDSMEFBO / 229034
- Conditions
- Type 2 Diabetes
- Keywords
- Family Model, Marshallese, Pacific Islander, Diabetes Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 5 Feb 2020 (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.
This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family DSMES | Experimental | Behavioral: Family Model Diabetes Self-Management Education and Support |
| Wait List | Experimental | Behavioral: Family Model Diabetes Self-Management Education and Support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-reported Marshallese
- 18 years of age or older
- have T2D (defined as having an HbA1c equal to or greater than 6.5)
- have at least one family member willing to take part
Key exclusion criteria (3 listed)
- has received DSME in the past five years
- has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
- plans to move out of the geographic region
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 Model Diabetes Self-Management Education and SupportParticipants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting. | Behavioural | Family DSMES, Wait List |
Primary outcome
Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points
Time frame: Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention
Measured by Change in Adjusted Mean HbA1c(%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, and 24 Months Post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Pearl McElfish, Phd, MDA principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Model Diabetes Self-Management Education and Support in people with Type 2 Diabetes, run by University of Arkansas 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 28 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points (time frame: Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.