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COMPLETED
NCT03188094
NA

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

The study "Integrated Community-Clinical Linkage Model to Promote Weight Loss among South Asians with Pre-Diabetes" is a two-arm randomized control trial that analyzes the implementation and effectiveness of a multi-component intervention on weight loss promotion tailored for South Asians. The intervention consists of two components (EHR and CHW) within NYC primary care practices (PCPs) that serve a large proportion of South Asian patients. The EHR intervention components are focused on: 1) generating routine patient registry reports that identify patients at risk for type-2 diabetes mellitus (DM) within each practice; and 2) developing and implementing medical alerts and order sets that are tailored to the South Asian patient population, including alerts to screening for BMI at ≥ 23 kg/m2. Using the EHR registry, a list of eligible patients is generated at each participating primary care site; and matched pair randomization to treatment/control groups (matched by age, gender, and BMI) is completed within the PCP cluster. Treatment group individuals receive a letter from their physician inviting them to participate in the CHW intervention and CHWs follow-up via phone for recruitment and enrollment. CHWs deliver a standardized curriculum on DM prevention that has been adapted from the DPP, which consists of five monthly 60-min group health education sessions that provide the tools and strategies necessary to promote weight loss and prevent DM. Over the total intervention period, a total of 480 treatment group participants will be enrolled. Matched control group participants will not be contacted by the research team or participate in research activities. De-identified clinical measures will be collected for both treatment and control participants from EHR data for final analysis. In order to explore barriers and facilitators to implementation and intervention adoption, qualitative in-depth interviews will be conducted with PCPs, healthcare payer representatives, and CHWs at baseline and 12-month follow-up.

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

974

Start Date

2018-12-17

Completion Date

2024-06-30

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

NYU Langone Health

New York, New York, United States