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

Not Applicable

Completed

• Conditions: Pre Diabetes; Weight Loss
• Interventions: Behavioral: CHW-Led Health Coaching; Other: EHR Alerts

• Registration Number: NCT03188094
• Lead Sponsor: NYU Langone Health

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.

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 Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Study Start: 2018-12-17
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 974

Inclusion Criteria

Provider Assessment Surveys

• clinicians employed by independent primary care practice that are members of HealthFirst's network and have enrolled into the study.

Key Informant Interviews

• must be a provider, clinic manger, Healthfisrt staff, or community health worker.

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Exclusion Criteria

Provider Assessment Surveys

• Exclusion criteria include the following: participants who are unable to complete the survey in the English language.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alert + CHW-Led Coaching	CHW-Led Health Coaching	Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round.
Alert + CHW-Led Coaching	EHR Alerts	Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round.

Primary Outcome Measures

Name	Time	Method
Percentage of participants who lose at least 5% of body weight between baseline and month 6	Baseline, Month 6

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c (HbA1c)	Baseline, Month 6
Change in HbA1c	Baseline, Month 12
Percentage of Patients who sustain at least 5% weight loss	From Month 6 up to Month 12	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.
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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States