Diabetes Management Intervention For South Asians

September 3, 2025 updated by: NYU Langone Health
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

859

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • One Park Avenue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant women and visits to obstetrician/gynecologist are excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHW-Led Health Coaching
Participants in the treatment group will be randomized to receive the CHW group education session intervention in either the first or second round.
Behavioral: Community Health Worker (CHW)-Led Health Coaching
CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to manage diabetes.
Other: EHR-Embedded Alerts
An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes.
No Intervention: Wait-List Control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referrals to community services
Time Frame: Up to Month 6
Number of referrals given to community service over the course of 6 months.
Up to Month 6
Change in Diabetes Self-Efficacy Score
Time Frame: Baseline, Month 6
Diabetes self-efficacy is measured using 4 questions rated on a scale from 1 (none of the time) to 5 (all of the time). The total score is the sum of responses and ranges from 4 to 20. Higher scores indicate greater diabetes self-efficacy.
Baseline, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Nadia Islam, PhD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2019

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-01479
  • U54MD000538-15 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

AFTER FINAL DATA COLLECTION AND FOLLOWING PUBLICATION OF MAIN FINDINGS MANUSCRIPT

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal. Requests should be directed to Shinu.Mammen@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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