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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK110048 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alert + CHW-Led Coaching | Experimental | Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round. |
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| Usual Care - Wait-List Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadia Islam | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40457309 | Derived | Gupta A, Wyatt LC, Mammen S, Zanowiak JM, Lim S, Islam NS, Kumar R, Beane S, Gold HT. Cost analysis of implementing a community health worker-led weight reduction randomized-controlled trial among prediabetic south asian patients at primary care sites in NYC. Implement Sci. 2025 Jun 2;20(1):26. doi: 10.1186/s13012-025-01439-2. | |
| 38669062 | Derived | Hu L, Wyatt LC, Mohsin F, Lim S, Zanowiak J, Mammen S, Hussain S, Ali SH, Onakomaiya D, Belli HM, Aifah A, Islam NS. Characterizing Technology Use and Preferences for Health Communication in South Asian Immigrants With Prediabetes or Diabetes: Cross-Sectional Descriptive Study. JMIR Form Res. 2024 Apr 26;8:e52687. doi: 10.2196/52687. |
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Primary care providers (PCPs) were not considered enrolled as participants in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Waive 1 (10/2018-12/2019) Round 1 Jan-Jun 2019, Round 2 July-Dec 2019 | All participants waitlisted during the Waive 1- Round 1 were randomized to the Waive 1 Wait-List Control group. During the first round (Jan-Jun 2019), participants received standard of care. During the second round (July-Dec 2019), all control participants were offered the full CHW group education sessions, though not for research purposes. Participants randomized to receive the intervention in Waive 1 received the intervention from Jan-Jun 2019 for Round 1; Round 2 participants received the intervention from July-Dec 2019. |
| FG001 | Waive 2 (10/2019-12/2020) Round 1 Jan-Jun 2020, Round 2 July-Dec 2020 | All participants waitlisted during the Waive 2 - Round 1 were randomized to the Waive 2 Wait-List Control group. During the first round (Jan-Jun 2020), participants received standard of care. During the second round (July-Dec 2020), all control participants were offered the full CHW group education sessions, though not for research purposes. Participants randomized to receive the intervention in Waive 2 received the intervention from Jan-Jun 2020 for Round 1; Round 2 participants received the intervention from July-Dec 2020. |
| FG002 | Waive 3 (10/2020-12/2021) Round 1 Jan-Jun 2021, Round 2 July-Dec 2021 | All participants waitlisted during the Waive 3 - Round 1 were randomized to the Waive 3 Wait-List Control group. During the first round (Jan-Jun 2021), participants received standard of care. During the second round (July-Dec 2021), all control participants were offered the full CHW group education sessions, though not for research purposes. Participants randomized to receive the intervention in Waive 3 received the intervention from Jan-Jun 2021 for Round 1; Round 2 participants received the intervention from July-Dec 2021. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care - Wait-List Control | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Percentage of participants | Baseline, Month 6 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care - Wait-List Control | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Zanowiak | NYU Langone Health | 212 263 0485 | Jennifer.Zanowiak@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2021 | Jun 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| 31752964 | Derived | Lim S, Wyatt LC, Mammen S, Zanowiak JM, Mohaimin S, Goldfeld KS, Shelley D, Gold HT, Islam NS. The DREAM Initiative: study protocol for a randomized controlled trial testing an integrated electronic health record and community health worker intervention to promote weight loss among South Asian patients at risk for diabetes. Trials. 2019 Nov 21;20(1):635. doi: 10.1186/s13063-019-3711-y. |
| Ineligible |
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| Lost to Follow-up |
|
| Alert + CHW-Led Coaching |
Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round. 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 476 |
| 0 |
| 476 |
| 0 |
| 476 |
| EG001 | Alert + CHW-Led Coaching | Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round. 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. 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. | 0 | 498 | 0 | 498 | 0 | 498 |
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| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |