An interventional study of CHW-Led Health Coaching and EHR Alerts in Pre Diabetes and Weight Loss, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention
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.
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:
778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.
This study's enrollment of 974 is above the median of 60 across 645 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round.
Behavioral: CHW-Led Health Coaching · Other: EHR Alerts
All 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.
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.
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.
Time frame: Baseline, Month 6
| Milestone | Waive 1 (10/2018-12/2019) Round 1 Jan-Jun 2019, Round 2 July-Dec 2019 | Waive 2 (10/2019-12/2020) Round 1 Jan-Jun 2020, Round 2 July-Dec 2020 | Waive 3 (10/2020-12/2021) Round 1 Jan-Jun 2021, Round 2 July-Dec 2021 |
|---|---|---|---|
| Started | 333 | 294 | 347 |
| Participants started wait-list control round 1, chw round 2 | 164 | 147 | 165 |
| Participants completed wait-list control round 1, chw round 2 | 164 | 147 | 165 |
| Participants started chw round 1, chw round 2 | 169 | 147 | 182 |
| Participants completed chw round 1, chw round 2 | 164 | 147 | 165 |
| Completed | 328 | 294 | 330 |
| Not completed | 5 | 0 | 17 |
| Withdrew: Screen failure | 1 | 0 | 0 |
| Withdrew: Pregnancy | 3 | 0 | 0 |
| Withdrew: Ineligible | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 17 |
Weight measured at baseline and 6 month survey via study scale.
| Percentage of participants | Usual Care - Wait-List Control | Alert + CHW-Led Coaching |
|---|---|---|
| Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6 | 11 | 19 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care - Wait-List Control | 0/476 (0%) | 0/476 (0%) | 0/476 (0%) |
| Alert + CHW-Led Coaching | 0/498 (0%) | 0/498 (0%) | 0/498 (0%) |
| Age, Continuous(years) | Usual Care - Wait-List Control | Alert + CHW-Led Coaching | Total |
|---|---|---|---|
| Mean | 48.3 ± 11.2 | 48.2 ± 11.2 | 48.3 ± 11.2 |
| Sex: Female, Male(Participants) | Usual Care - Wait-List Control | Alert + CHW-Led Coaching | Total |
|---|---|---|---|
| Female | 274 | 274 | 548 |
| Male | 202 | 202 | 404 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care - Wait-List Control | Alert + CHW-Led Coaching | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 476 | 476 | 952 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Usual Care - Wait-List Control | Alert + CHW-Led Coaching | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 476 | 476 | 952 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Usual Care - Wait-List Control | Alert + CHW-Led Coaching | Total |
|---|---|---|---|
| United States | 476 | 476 | 952 |
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