Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes

The proposed study will inform efforts to prevent diabetes and promote weight loss in a high-risk population and generate a reproducible, scalable, and sustainable model for use with other insurer groups and clinical settings that work in immigrant populations with a high burden of chronic disease.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Pre Diabetes
• Intervention / Treatment: Behavioral: CHW-Led Health Coaching; Other: EHR Alerts

Detailed Description

The study "Integrated Community-Clinical Linkage Model to Promote Weight Loss among South Asians with Pre-Diabetes" aims to test the effectiveness and assess the implementation process of an integrated intervention to support weight loss for South Asian patients at-risk for type-2 diabetes mellitus (T2DM) in primary care settings. The integrated intervention involves:

1. An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to increase screening and identification of South Asian patients at-risk for T2DM with BMI >23 kg/m2 and registries to track outcomes: and
2. Registry-driven community health worker (CHW)-led health coaching for patients. Using a stepped-wedge design, we will implement the study in 25 New York City PCP sites enrolling 2,840 South Asian patients at- risk for T2DM.
3. Provider Surveys (n=40) to capture data on satisfaction with workflow before and after intervention, information sources for EHR-CHW initiatives before and after intervention, acceptability of and satisfaction with the integrated EHR-CHW intervention, and barriers and facilitators of point-of-care use of the tools.
4. Key Informant Interviews (n=35) with physician champions at each site and/or administrator of each site, Health first representatives, and CHWs. At baseline, the interviews will be incorporated into the workflow analysis to assess current satisfaction and usage of EHR and health coaching. At follow-up, the interviews will assess barriers and facilitators to the implementation and adoption process of the integrated EHR-CHW intervention, fidelity to the interventions, and to solicit recommendations for the replication and scalability of the intervention to other sites and insurer organizations.

• Study Type: Interventional
• Enrollment (Actual): 974
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

The overall number of subjects expected to participate in this study is 2,915. This includes a total of 2,840 participants in the EHR-CHW Intervention, 40 subjects who participate in the surveys and 35 particpants in the key informant interviews.

Description

Inclusion Criteria:

• self identify as South Asian;
• are at least 21 years of age and younger than age 75,
• had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months;
• have a BMI of >23; and
• have incident pre-diabetes as determined by HbA1c test (last A1c test date in the last 12 months).

Exclusion Criteria:

• Patients under the age of 21 and older than 75 will be excluded.
• Individuals with a diagnosis of diabetes or pre-diabetes during the 12 months prior to intervention implementation will be excluded.
• Pregnant women and all visits with an obstetrician gynecologist are excluded.
• No children or vulnerable subjects will be enrolled in this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alert + CHW-Led Coaching; Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round.	Behavioral: CHW-Led Health Coaching; The CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to prevent diabetes.; Other: EHR Alerts; Primary care providers (PCP) treating patients in the intervention group will receive embedded EHR alerts to increase screening and identification of South Asian patients at-risk for T2DM with BMI >23 kg/m2 and registries to track outcomes.
No Intervention: Usual Care - Wait-List Control; All participants waitlisted during the first round will be randomized to the control group. Control group participants will be offered the full CHW group education sessions during the second round. The control participants will receive usual care during the first round.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6	Weight measured at baseline and 6 month survey via study scale.	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c		Baseline, Month 12
Change in Blood Pressure Level		Baseline, Month 6
Change in Hemoglobin A1c (HbA1c)		Baseline, Month 6
Percentage of Patients who sustain at least 5% weight loss	Percentage of Patients who sustain at least 5% weight loss from month 6 to month 12; measured among individuals with at least 5% weight loss from baseline to month 6.	From Month 6 up to Month 12
Change in low-density lipoprotein (LDL) cholesterol level		Baseline, Month 6
Change in LDL cholesterol level		Baseline, Month 12
Change in high-density lipoprotein (HDL) cholesterol level		Baseline, Month 6
Change in HDL cholesterol level		Baseline, Month 12
Change in Blood Pressure Level		Baseline, Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Nadia Islam, NYU Langone Health

Publications and helpful links

General Publications

• Lim S, Wyatt LC, Mammen S, Zanowiak JM, Mohaimin S, Goldfeld KS, Shelley D, Gold HT, Islam NS. The DREAM Initiative: study protocol for a randomized controlled trial testing an integrated electronic health record and community health worker intervention to promote weight loss among South Asian patients at risk for diabetes. Trials. 2019 Nov 21;20(1):635. doi: 10.1186/s13063-019-3711-y.
• 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.
• Gupta A, Wyatt LC, Mammen S, Zanowiak JM, Lim S, Islam NS, Kumar R, Beane S, Gold HT. Cost analysis of implementing a community health worker-led weight reduction randomized-controlled trial among prediabetic south asian patients at primary care sites in NYC. Implement Sci. 2025 Jun 2;20(1):26. doi: 10.1186/s13012-025-01439-2.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 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: Metabolic Diseases; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Hyperglycemia; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Weight Loss; Glucose Intolerance
• Other Study ID Numbers: 17-00693; 1R01DK110048 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No