Community Health Worker Diabetes Prevention Intervention (RICE)

May 8, 2018 updated by: NYU Langone Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

954

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in weight
Time Frame: 3 Months, 6 Months, 12 Months
3 Months, 6 Months, 12 Months
Change in Body Mass Index
Time Frame: 3 Months, 6 Months, 12 Months
3 Months, 6 Months, 12 Months
Change in hip-to-waist ratio measurements
Time Frame: 3 Months, 6 Months, 12 Months
3 Months, 6 Months, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2014

Primary Completion (Actual)

February 13, 2015

Study Completion (Actual)

February 13, 2015

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-01416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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