Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
Public ClinicalTrials.gov record NCT03188094. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03188094
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 974 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2018 (Actual)
- Primary completion
- Jun 30, 2024 (Actual)
- Completion
- Jun 30, 2024 (Actual)
- Last update posted
- Oct 9, 2026
2018 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03188094, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03188094 live on ClinicalTrials.gov.