NCT03530579

Brief 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. 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
954

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 8, 2018

Last Update Submit

May 8, 2018

Conditions

Diabetes Prevention

Keywords

Diabetes Prevention

Outcome Measures

Primary Outcomes (3)

  • Change in weight

    3 Months, 6 Months, 12 Months

  • Change in Body Mass Index

    3 Months, 6 Months, 12 Months

  • Change in hip-to-waist ratio measurements

    3 Months, 6 Months, 12 Months

Study Arms (2)

Group 1

EXPERIMENTAL

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

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.

Behavioral: Community Health Care Worker

Interventions

Educational group trainingsBEHAVIORAL

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

Group 1
Community Health Care WorkerBEHAVIORAL

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

Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36273386DERIVED

Study Officials

  • Nadia Islam, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

February 13, 2014

Primary Completion

February 13, 2015

Study Completion

February 13, 2015

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share