Diabetes Management Intervention For South Asians

NCT03333044 | Completed Results

• 2 other identifiers: 17-01479U54MD000538-15
• Study Type: interventional
• Target: 859
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months

  Measured via complete lipoprotein panel.

  Baseline, Month 6

Study Arms (2)

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.

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).

Interventions

Community Health Worker (CHW)-Led Health Coaching 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.

CHW-Led Health Coaching

EHR-Embedded Alerts OTHER

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

CHW-Led Health Coaching

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

One Park Avenue

New York, New York, 10016, United States

Location

Related Publications (4)

• 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.

  PMID: 39894868 DERIVED

• 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.

  PMID: 38669062 DERIVED

• 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.

  PMID: 37333263 DERIVED

• 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.

  PMID: 34814899 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Shinu Mammen
• Organization: NYU Langone Health

shinu.mammen@nyulangone.org

646-501-3484

Study Officials

• Nadia Islam, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: July 11, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: AFTER FINAL DATA COLLECTION AND FOLLOWING PUBLICATION OF MAIN FINDINGS MANUSCRIPT
• 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.

Locations

US (1)