Pre DiabetesNCT03188094
Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
A study testing CHW-Led Health Coaching and EHR Alerts in people with Pre Diabetes and Weight Loss, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pre Diabetes, Weight Loss
- What is being tested?
- CHW-Led Health Coaching and EHR Alerts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 974 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self identify as South Asian;
- are at least 21 years of age and younger than age 75,
- had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months;
- have a BMI of >23; and
- have incident pre-diabetes as determined by HbA1c test (last A1c test date in the last 12 months).
Who cannot join
- Patients under the age of 21 and older than 75 will be excluded.
- Individuals with a diagnosis of diabetes or pre-diabetes during the 12 months prior to intervention implementation will be excluded.
- Pregnant women and all visits with an obstetrician gynecologist are excluded.
- No children or vulnerable subjects will be enrolled in this study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pre Diabetes, Weight Loss
- Being tested
- CHW-Led Health Coaching, EHR Alerts
- Medical subject headings
- Glucose Intolerance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW-Led Health CoachingBehavioural
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 AlertsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Alert + CHW-Led Coaching | Experimental | Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round. Receives: Behavioral: CHW-Led Health Coaching; Other: EHR Alerts |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start17 Dec 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Islam, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188094
- Sponsor's protocol ID
- 17-00693
- Other IDs
- 1R01DK110048
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2017
- Last updated
- 9 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40457309Hu 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.
PubMed 38669062Lim 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.
PubMed 31752964
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
- ClinicalTrials.gov ID
- NCT03188094
- Acronym / sponsor ID
- 17-00693
- Conditions
- Pre Diabetes, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alert + CHW-Led Coaching | Experimental | Behavioral: CHW-Led Health Coaching, Other: EHR AlertsParticipants will receive an alert and registry-driven CHW-led coaching during either the first or second round. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self identify as South Asian;
- are at least 21 years of age and younger than age 75,
- had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months;
- have a BMI of >23; and
- have incident pre-diabetes as determined by HbA1c test (last A1c test date in the last 12 months).
Key exclusion criteria (4 listed)
- Patients under the age of 21 and older than 75 will be excluded.
- Individuals with a diagnosis of diabetes or pre-diabetes during the 12 months prior to intervention implementation will be excluded.
- Pregnant women and all visits with an obstetrician gynecologist are excluded.
- No children or vulnerable subjects will be enrolled in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW-Led Health CoachingThe CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to prevent diabetes. | Behavioural | Alert + CHW-Led Coaching |
| EHR AlertsPrimary 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. | Other | Alert + CHW-Led Coaching |
Primary outcome
Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6
Time frame: Baseline, Month 6
Weight measured at baseline and 6 month survey via study scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40457309Gupta 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.
- Derived from this study: PubMed 38669062Hu 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.
- Derived from this study: PubMed 31752964Lim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Islam principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW-Led Health Coaching and EHR Alerts in people with Pre Diabetes and Weight Loss, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6 (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188094, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.