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CompletedNCT03530579RICEUpdated May 21, 2018

Community Health Worker Diabetes Prevention Intervention

An interventional study of Educational group trainings and Community Health Care Worker in Diabetes Prevention, sponsored by NYU Langone Health. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Feb 2014, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
954
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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;
  2. 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.
02

Conditions studied

  • Diabetes Prevention

Keywords

  • Diabetes Prevention
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.

Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.

Browse NYU Langone Health studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Enrollment
954 participants (actual)

Study arms

  • Experimental
    Group 1

    Participants will receive 6 two and a half hour educational group trainings over the course of 6 months.

    Behavioral: Educational group trainings

  • Active comparator
    Group 2

    A community health worker will answer your questions about diabetes and refer participant if you need one.

    Behavioral: Community Health Care Worker

Interventions

  • BehavioralEducational group trainings

    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

  • BehavioralCommunity Health Care Worker

    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

06

What researchers measure

Primary outcomes

  1. Change in weight

    Time frame: 3 Months, 6 Months, 12 Months

  2. Change in Body Mass Index

    Time frame: 3 Months, 6 Months, 12 Months

  3. Change in hip-to-waist ratio measurements

    Time frame: 3 Months, 6 Months, 12 Months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2014 to primary completion in Feb 2015, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2018
First posted
May 21, 2018
StartActual
Feb 13, 2014
Primary completionActual
Feb 13, 2015
CompletionActual
Feb 13, 2015
Last update
May 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03530579
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
May 21, 2018
Start date
Feb 13, 2014
Primary completion
Feb 13, 2015
Completion
Feb 13, 2015
Last update
May 21, 2018

Study contacts

Nadia Islam, PhD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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