Diabetes MellitusNCT03006666
Integrating Community Health Workers to Improve Diabetes Prevention
A study testing CHW Training and Data Only in people with Diabetes Mellitus, run by NYU Langone Health at 1 site in United States.
Trial summary
Cluster randomized trial to test the impact of peer health coaches on prediabetic patients. This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to promote prevention of Diabetes Mellitus in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- CHW Training and Data Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 773 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2017to 28 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having at least one HbA1c result in the prediabetic range (5.7-6.5%) in the 5 years prior to the start date of Phase 2.
Who cannot join
- A diagnosis of DM, based on ICD-9 codes applied during ambulatory encounters in the 2 years prior to Phase 2
- Treatment with DM medication other than metformin (e.g. insulin or oral agents)
- age greater than 75 years
- exclusion by patient's PCP due to contraindication for lifestyle intervention or CHW outreach.
- Does not speak English or Spanish (necessary to communicate with community health worker)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Medical Center
New York, New York, 10016
About this study
Official title: Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities
Cluster randomized trial to test the impact of peer health coaches on prediabetic patients. This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.
Read the detailed description
This population based trial aims to understand the impact of peer health interventions on panels of patients in a real clinic environment
Investigators will conduct a cluster-randomized trial to test the impact of peer health coaches on prediabetic patients cared for by patient-centered medical home model (PCMH) teams to:
- Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;
- Promote weight loss among pre-diabetic patients;
- Increase patient activation levels, a measureable construct of engagement, efficacy, skills, and confidence in managing one's health, among pre-DM patients, resulting in:
- Improved secondary clinical outcomes: better glycemic and blood pressure control, and lower Framingham risk scores;
- Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy Lifestyles, etc);
- Improved health behaviors (e.g. making dietary and exercise changes); and
- Develop, implement and assess strategies to recruit, train, and integrate peer CHW health coaches within the PCMH model.
This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus (DM),using low cost, culturally congruent personnel to promote prevention of DM in PCMH practice.
- Conditions
- Diabetes Mellitus
- Being tested
- CHW Training, Data Only
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW TrainingBehavioural
CHWs will be trained in DM concepts, motivational interviewing, brief action planning, and stages of behavior change. CHWs will participate in a 105- hour core competency training. CHWs will conduct mock telephone counseling calls with trained standardized patients to enhance skills, gain feedback and develop confidence in these techniques.
In addition to these training experiences, CHWs will have letter templates, motivational interviewing scripts, and protocols available for patient outreach to standardize and guide patient outreach .
The completion of the CHW training will be followed by a final examination of knowledge and evaluation of trial encounters with "mock" participants (consisting of research staff and advisory board members).
Individuals who do not pass will receive intensive remediation and be required to repeat the examination.
Community Health Worker Coaching Intervention.
Data OnlyBehavioural
The teams randomly allocated will not have access to Community Health Workers.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Data Only) | Active comparator | The teams randomly allocated to the Control Group will not have access to CHWs. Receives: Behavioral: Data Only |
| Intervention Group: (CHW Health Coaching Integrated into Team) | Experimental | Teams randomly allocated to the Intervention Group will also receive regular panel data on their pre-DM patients and will have a CHW join the team, attend team meetings, and provide an outreach intervention to all prediabetic patients in the panel, as described below. CHWs and the researchers will provide regular updates to the team on these activities. Receives: Behavioral: CHW Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates of type 2 DM
Cumulative DM incidence rates and time to DM incidence
Measured: 36 Months
Weight loss and obesity rates
Will conduct chi-square test to compare DM incidence rates at 36-months follow-up of the intervention and control arms.
Measured: 36 Months
Patient Activation Measure (PAM) scores
The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start13 Jul 2017
- Primary completion1 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Schwartz, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006666
- Sponsor's protocol ID
- 16-00690
- Status last verified
- Jun 2022
- First submitted
- 27 Dec 2016
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schwartz MD, Hu J, Sherman SE, Gore R, Levy N, Tanner M, Bergman M, Islam N. Community health worker intervention to prevent incident type 2 diabetes: A cluster randomized trial. PLoS One. 2026 Oct 30;21(10):e0361464. doi: 10.1371/journal.pone.0361464. eCollection 2026.
PubMed 42961875Gupta A, Hu J, Huang S, Diaz L, Gore R, Levy N, Bergman M, Tanner M, Sherman SE, Islam N, Schwartz MD. Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices. BMC Public Health. 2023 Mar 28;23(1):575. doi: 10.1186/s12889-023-15477-2.
PubMed 36978071Islam N, Gepts T, Lief I, Gore R, Levy N, Tanner M, Fang Y, Sherman SE, Schwartz MD. Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes. BMC Public Health. 2018 Apr 19;18(1):521. doi: 10.1186/s12889-018-5419-4.
PubMed 29673333
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities
- ClinicalTrials.gov ID
- NCT03006666
- Acronym / sponsor ID
- 16-00690
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cluster randomized trial to test the impact of peer health coaches on prediabetic patients. This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.
Detailed description
This population based trial aims to understand the impact of peer health interventions on panels of patients in a real clinic environment
Investigators will conduct a cluster-randomized trial to test the impact of peer health coaches on prediabetic patients cared for by patient-centered medical home model (PCMH) teams to:
- Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;
- Promote weight loss among pre-diabetic patients;
- Increase patient activation levels, a measureable construct of engagement, efficacy, skills, and confidence in managing one's health, among pre-DM patients, resulting in:
- Improved secondary clinical outcomes: better glycemic and blood pressure control, and lower Framingham risk scores;
- Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy Lifestyles, etc);
- Improved health behaviors (e.g. making dietary and exercise changes); and
- Develop, implement and assess strategies to recruit, train, and integrate peer CHW health coaches within the PCMH model.
This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus (DM),using low cost, culturally congruent personnel to promote prevention of DM in PCMH practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (Data Only) | Active comparator | Behavioral: Data OnlyThe teams randomly allocated to the Control Group will not have access to CHWs. |
| Intervention Group: (CHW Health Coaching Integrated into Team) | Experimental | Behavioral: CHW TrainingTeams randomly allocated to the Intervention Group will also receive regular panel data on their pre-DM patients and will have a CHW join the team, attend team meetings, and provide an outreach intervention to all prediabetic patients in the panel, as described below. CHWs and the researchers will provide regular updates to the team on these activities. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having at least one HbA1c result in the prediabetic range (5.7-6.5%) in the 5 years prior to the start date of Phase 2.
Key exclusion criteria (5 listed)
- A diagnosis of DM, based on ICD-9 codes applied during ambulatory encounters in the 2 years prior to Phase 2
- Treatment with DM medication other than metformin (e.g. insulin or oral agents)
- age greater than 75 years
- exclusion by patient's PCP due to contraindication for lifestyle intervention or CHW outreach.
- Does not speak English or Spanish (necessary to communicate with community health worker)
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 TrainingCHWs will be trained in DM concepts, motivational interviewing, brief action planning, and stages of behavior change. CHWs will participate in a 105- hour core competency training. CHWs will conduct mock telephone counseling calls with trained standardized patients to enhance skills, gain feedback and develop confidence in these techniques. In addition to these training experiences, CHWs will have letter templates, motivational interviewing scripts, and protocols available for patient outreach to standardize and guide patient outreach . The completion of the CHW training will be followed by a final examination of knowledge and evaluation of trial encounters with "mock" participants (consisting of research staff and advisory board members). Individuals who do not pass will receive intensive remediation and be required to repeat the examination. Community Health Worker Coaching Intervention. | Behavioural | Intervention Group: (CHW Health Coaching Integrated into Team) |
| Data OnlyThe teams randomly allocated will not have access to Community Health Workers. | Behavioural | Control Group (Data Only) |
Primary outcome
Incidence rates of type 2 DM
Time frame: 36 Months
Cumulative DM incidence rates and time to DM incidence
Weight loss and obesity rates
Time frame: 36 Months
Will conduct chi-square test to compare DM incidence rates at 36-months follow-up of the intervention and control arms.
Patient Activation Measure (PAM) scores
Time frame: 36 Months
The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 42961875Schwartz MD, Hu J, Sherman SE, Gore R, Levy N, Tanner M, Bergman M, Islam N. Community health worker intervention to prevent incident type 2 diabetes: A cluster randomized trial. PLoS One. 2026 Oct 30;21(10):e0361464. doi: 10.1371/journal.pone.0361464. eCollection 2026.
- Derived from this study: PubMed 36978071Gupta A, Hu J, Huang S, Diaz L, Gore R, Levy N, Bergman M, Tanner M, Sherman SE, Islam N, Schwartz MD. Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices. BMC Public Health. 2023 Mar 28;23(1):575. doi: 10.1186/s12889-023-15477-2.
- Derived from this study: PubMed 29673333Islam N, Gepts T, Lief I, Gore R, Levy N, Tanner M, Fang Y, Sherman SE, Schwartz MD. Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes. BMC Public Health. 2018 Apr 19;18(1):521. doi: 10.1186/s12889-018-5419-4.
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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.
Mark Schwartz, MD principal investigator
NYU School of Medicine
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 Training and Data Only in people with Diabetes Mellitus, 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 1 inclusion and 5 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 7 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence rates of type 2 DM (time frame: 36 Months). The study lists 3 primary outcomes in all. 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 NCT03006666, 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 7 Jun 2022.