HbA1cNCT03333044
Diabetes Management Intervention For South Asians
A study testing Community Health Worker (CHW)-Led Health Coaching and EHR-Embedded Alerts in people with HbA1c and Diabetes, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- What is being tested?
- Community Health Worker (CHW)-Led Health Coaching and EHR-Embedded Alerts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 859 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- South Asian ethnicity (identified through a race and language code available in the EHR);
- an appointment with a physician for routine non-emergent primary care in the last 12 months
- diagnosis of diabetes
- an HbA1c reading of >7 in the last 12 months
Who cannot join
- Pregnant women and visits to obstetrician/gynecologist are excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated identification and referral to culturally relevant community resources for patients; and 4) HIT-enabled care coordination between the CHW and other members of the healthcare team.
- Being tested
- Community Health Worker (CHW)-Led Health Coaching, EHR-Embedded Alerts
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker (CHW)-Led Health CoachingBehavioural
CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to manage diabetes.
EHR-Embedded AlertsOther
An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes.
| Study group | Role | What they receive |
|---|---|---|
| CHW-Led Health Coaching | Experimental | Participants in the treatment group will be randomized to receive the CHW group education session intervention in either the first or second round. Receives: Behavioral: Community Health Worker (CHW)-Led Health Coaching; Other: EHR-Embedded Alerts |
| Wait-List Control | No intervention | Participants in the wait-list control group will be receive care as usual during the first round for data abstraction and offered CHW group education sessions during the second round as a point of service (i.e., not for research purposes). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months
Measured via complete lipoprotein panel.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start11 Jul 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HbA1cStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 859 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Nadia Islam, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333044
- Sponsor's protocol ID
- 17-01479
- Other IDs
- U54MD000538-15
- Status last verified
- Sep 2025
- First submitted
- 2 Nov 2017
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Mohsin F, Wyatt L, Belli H, Ali S, Onakomaiya D, Misra S, Yusuf Y, Mammen S, Zanowiak J, Hussain S, Zafar H, Lim S, Islam N, Ahmed N. Diabetes distress among immigrants of south Asian descent living in New York City: baseline results from the DREAM randomized control trial. BMC Public Health. 2025 Feb 2;25(1):422. doi: 10.1186/s12889-025-21535-8.
PubMed 39894868Hu L, Wyatt LC, Mohsin F, Lim S, Zanowiak J, Mammen S, Hussain S, Ali SH, Onakomaiya D, Belli HM, Aifah A, Islam NS. Characterizing Technology Use and Preferences for Health Communication in South Asian Immigrants With Prediabetes or Diabetes: Cross-Sectional Descriptive Study. JMIR Form Res. 2024 Apr 26;8:e52687. doi: 10.2196/52687.
PubMed 38669062Mohsin F, Wyatt L, Belli H, Ali S, Onakomaiya D, Misra S, Yusuf Y, Mammen S, Zanowiak J, Hussain S, Zafar H, Lim S, Islam N, Ahmed N. The Prevalence and Correlates of Diabetes Distress among South Asians Living in New York City (NYC): Baseline Results from a Randomized Trial. Res Sq [Preprint]. 2023 Jun 8:rs.3.rs-2806895. doi: 10.21203/rs.3.rs-2806895/v1.
PubMed 37333263Lim S, Wyatt LC, Mammen S, Zanowiak JM, Mohaimin S, Troxel AB, Lindau ST, Gold HT, Shelley D, Trinh-Shevrin C, Islam NS. Implementation of a multi-level community-clinical linkage intervention to improve glycemic control among south Asian patients with uncontrolled diabetes: study protocol of the DREAM initiative. BMC Endocr Disord. 2021 Nov 23;21(1):233. doi: 10.1186/s12902-021-00885-5.
PubMed 34814899
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Management Intervention For South Asians
- ClinicalTrials.gov ID
- NCT03333044
- Acronym / sponsor ID
- 17-01479
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 859 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated identification and referral to culturally relevant community resources for patients; and 4) HIT-enabled care coordination between the CHW and other members of the healthcare team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHW-Led Health Coaching | Experimental | Behavioral: Community Health Worker (CHW)-Led Health Coaching, Other: EHR-Embedded AlertsParticipants in the treatment group will be randomized to receive the CHW group education session intervention in either the first or second round. |
| Wait-List Control | No intervention | –Participants in the wait-list control group will be receive care as usual during the first round for data abstraction and offered CHW group education sessions during the second round as a point of service (i.e., not for research purposes). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- South Asian ethnicity (identified through a race and language code available in the EHR);
- an appointment with a physician for routine non-emergent primary care in the last 12 months
- diagnosis of diabetes
- an HbA1c reading of >7 in the last 12 months
Key exclusion criteria (1 listed)
- Pregnant women and visits to obstetrician/gynecologist are excluded from the study
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 |
|---|---|---|
| Community Health Worker (CHW)-Led Health CoachingCHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to manage diabetes. | Behavioural | CHW-Led Health Coaching |
| EHR-Embedded AlertsAn electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes. | Other | CHW-Led Health Coaching |
Primary outcome
Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months
Time frame: Baseline, Month 6
Measured via complete lipoprotein panel.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39894868Mohsin F, Wyatt L, Belli H, Ali S, Onakomaiya D, Misra S, Yusuf Y, Mammen S, Zanowiak J, Hussain S, Zafar H, Lim S, Islam N, Ahmed N. Diabetes distress among immigrants of south Asian descent living in New York City: baseline results from the DREAM randomized control trial. BMC Public Health. 2025 Feb 2;25(1):422. doi: 10.1186/s12889-025-21535-8.
- Derived from this study: PubMed 38669062Hu L, Wyatt LC, Mohsin F, Lim S, Zanowiak J, Mammen S, Hussain S, Ali SH, Onakomaiya D, Belli HM, Aifah A, Islam NS. Characterizing Technology Use and Preferences for Health Communication in South Asian Immigrants With Prediabetes or Diabetes: Cross-Sectional Descriptive Study. JMIR Form Res. 2024 Apr 26;8:e52687. doi: 10.2196/52687.
- Derived from this study: PubMed 37333263Mohsin F, Wyatt L, Belli H, Ali S, Onakomaiya D, Misra S, Yusuf Y, Mammen S, Zanowiak J, Hussain S, Zafar H, Lim S, Islam N, Ahmed N. The Prevalence and Correlates of Diabetes Distress among South Asians Living in New York City (NYC): Baseline Results from a Randomized Trial. Res Sq [Preprint]. 2023 Jun 8:rs.3.rs-2806895. doi: 10.21203/rs.3.rs-2806895/v1.
- Derived from this study: PubMed 34814899Lim S, Wyatt LC, Mammen S, Zanowiak JM, Mohaimin S, Troxel AB, Lindau ST, Gold HT, Shelley D, Trinh-Shevrin C, Islam NS. Implementation of a multi-level community-clinical linkage intervention to improve glycemic control among south Asian patients with uncontrolled diabetes: study protocol of the DREAM initiative. BMC Endocr Disord. 2021 Nov 23;21(1):233. doi: 10.1186/s12902-021-00885-5.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Nadia Islam, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker (CHW)-Led Health Coaching and EHR-Embedded Alerts in people with HbA1c and Diabetes, run by NYU Langone Health 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 1 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 24 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months (time frame: Baseline, Month 6). 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 NCT03333044, which also lists 4 linked publications.
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 24 Sep 2025.