Diabetes Management Intervention For South Asians

NCT ID: NCT03333044

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 859 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2024-06-30

Brief 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 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.

Conditions

HbA1c; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Community Health Worker (CHW)-Led Health Coaching

Intervention Type: BEHAVIORAL

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 Alerts

Intervention Type: OTHER

An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Islam, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

One Park Avenue

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39894868 (View on PubMed)

Hu 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.

Reference Type: DERIVED

PMID: 38669062 (View on PubMed)

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. 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.

Reference Type: DERIVED

PMID: 37333263 (View on PubMed)

Lim 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.

Reference Type: DERIVED

PMID: 34814899 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U54MD000538-15

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-01479

Identifier Type: -

Identifier Source: org_study_id