Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
2 other identifiers
interventional
974
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 15, 2017
CompletedStudy Start
First participant enrolled
December 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedResults Posted
Study results publicly available
September 24, 2025
CompletedSeptember 24, 2025
September 1, 2025
5.5 years
June 6, 2017
June 27, 2025
September 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Alert + CHW-Led Coaching
EXPERIMENTALParticipants will receive an alert and registry-driven CHW-led coaching during either the first or second round.
Usual Care - Wait-List Control
NO INTERVENTIONAll 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Related Publications (3)
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.
PMID: 40457309DERIVEDHu 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: 38669062DERIVEDLim 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.
PMID: 31752964DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Zanowiak
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Nadia Islam
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2017
First Posted
June 15, 2017
Study Start
December 17, 2018
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