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Completed

NCT Number: NCT03188094

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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:

  • 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
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHW-Led Health Coaching

Behavioral

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.

EHR Alerts

Other

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.

Primary outcomes

  1. Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6

    Time frame: Baseline, Month 6

    Weight measured at baseline and 6 month survey via study scale.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2017
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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