Diabetes PreventionRICENCT03530579
Community Health Worker Diabetes Prevention Intervention
A study testing Educational group trainings and Community Health Care Worker in people with Diabetes Prevention, run by NYU Langone Health.
Trial summary
The primary goal of this study is to develop, implement, and test a community health worker (CHW) program designed to promote diabetes prevention among Korean and South Asian Americans in New York City. In particular, the specific aims of this study are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention
- What is being tested?
- Educational group trainings and Community Health Care Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 954 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2014to 13 Feb 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- is a South Asian or Korean American immigrant;
- is identified as at-risk by a diabetes risk assessment
- is between 18-75 years of age; and
- is willing to be randomized to either treatment or control groups.
Who cannot join
- is a confirmed diabetic;
- is on renal dialysis;
- has an acute or terminal illness or serious mental illness;
- has a history of recent coronary event within the last 12 months;
- has a recent history of acute medical problem or admission to hospital;
- has any other severe medical conditions that might make it difficult to attend educational sessions;
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- has poor short-term prognosis (expected death in <2 years);
- is planning to travel for longer than 6 weeks during the 6-month intervention period; or
- is participating in another CVD study.
About this study
The primary goal of this study is to develop, implement, and test a community health worker (CHW) program designed to promote diabetes prevention among Korean and South Asian Americans in New York City.
In particular, the specific aims of this study are:
- To utilize community based participatory research (CBPR) methods to expand upon an existing campus-community partnership to develop and implement a CHW program among Korean and South Asian Americans that promotes diabetes prevention;
- To develop, implement, and assess the efficacy of a CHW intervention to promote diabetes prevention and access to care among NYC Koreans and South Asians.
- Conditions
- Diabetes Prevention
- Being tested
- Educational group trainings, Community Health Care Worker
- Keywords
- Diabetes Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational group trainingsBehavioural
Participants will receive 6 two and a half hour educational group training's over the course of 6 months. These sessions will be led by a trained CHW in your language and will be held on a monthly basis in a community based location.
Session 1: What is Diabetes
- Why is Prevention Important
Session 2: Nutrition Session 3: Physical Activity Session 4: Cardiovascular Disease \& Diabetes Complication Session 5: Stress Management Session 6: Access to Service
Community Health Care WorkerBehavioural
A community health care worker answer your questions about diabetes and refer participant to a physician. Survey will be completed at the start of the study and during the 3rd, 6th and 12th months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive 6 two and a half hour educational group trainings over the course of 6 months. Receives: Behavioral: Educational group trainings |
| Group 2 | Active comparator | A community health worker will answer your questions about diabetes and refer participant if you need one. Receives: Behavioral: Community Health Care Worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Measured: 3 Months, 6 Months, 12 Months
Change in Body Mass Index
Measured: 3 Months, 6 Months, 12 Months
Change in hip-to-waist ratio measurements
Measured: 3 Months, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start13 Feb 2014
- Primary completion13 Feb 2015
- Study completion13 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes PreventionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 954 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Islam, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530579
- Sponsor's protocol ID
- 11-01416
- Acronym
- RICE
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
PubMed 36273386
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker Diabetes Prevention Intervention
- ClinicalTrials.gov ID
- NCT03530579
- Acronym / sponsor ID
- RICE / 11-01416
- Conditions
- Diabetes Prevention
- Keywords
- Diabetes Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 954 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Feb 2014 (actual)
- Primary completion
- 13 Feb 2015 (actual)
- Study completion
- 13 Feb 2015 (actual)
- First posted
- 21 May 2018 (actual)
- 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.
The primary goal of this study is to develop, implement, and test a community health worker (CHW) program designed to promote diabetes prevention among Korean and South Asian Americans in New York City.
In particular, the specific aims of this study are:
- To utilize community based participatory research (CBPR) methods to expand upon an existing campus-community partnership to develop and implement a CHW program among Korean and South Asian Americans that promotes diabetes prevention;
- To develop, implement, and assess the efficacy of a CHW intervention to promote diabetes prevention and access to care among NYC Koreans and South Asians.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Educational group trainingsParticipants will receive 6 two and a half hour educational group trainings over the course of 6 months. |
| Group 2 | Active comparator | Behavioral: Community Health Care WorkerA community health worker will answer your questions about diabetes and refer participant if you need one. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- is a South Asian or Korean American immigrant;
- is identified as at-risk by a diabetes risk assessment
- is between 18-75 years of age; and
- is willing to be randomized to either treatment or control groups.
Key exclusion criteria (9 listed)
- is a confirmed diabetic;
- is on renal dialysis;
- has an acute or terminal illness or serious mental illness;
- has a history of recent coronary event within the last 12 months;
- has a recent history of acute medical problem or admission to hospital;
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 |
|---|---|---|
| Educational group trainingsParticipants will receive 6 two and a half hour educational group training's over the course of 6 months. These sessions will be led by a trained CHW in your language and will be held on a monthly basis in a community based location. Session 1: What is Diabetes * Why is Prevention Important Session 2: Nutrition Session 3: Physical Activity Session 4: Cardiovascular Disease \& Diabetes Complication Session 5: Stress Management Session 6: Access to Service | Behavioural | Group 1 |
| Community Health Care WorkerA community health care worker answer your questions about diabetes and refer participant to a physician. Survey will be completed at the start of the study and during the 3rd, 6th and 12th months | Behavioural | Group 2 |
Primary outcome
Change in weight
Time frame: 3 Months, 6 Months, 12 Months
Change in Body Mass Index
Time frame: 3 Months, 6 Months, 12 Months
Change in hip-to-waist ratio measurements
Time frame: 3 Months, 6 Months, 12 Months
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 21 May 2018.
- Derived from this study: PubMed 36273386Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing Educational group trainings and Community Health Care Worker in people with Diabetes Prevention, run by NYU Langone Health.
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 4 inclusion and 9 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in weight (time frame: 3 Months, 6 Months, 12 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 NCT03530579, which also lists 1 linked publication.
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 21 May 2018.