Community Health Worker Diabetes Prevention Intervention

Diabetes Prevention Clinical Trial

— RICE  

Official title:

Community Health Worker Diabetes Prevention Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530579
• Other study ID #: 11-01416
• Status: Completed
• Phase: N/A
• Start date: February 13, 2014
• Est. completion date: February 13, 2015

Study information

• Verified date: May 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 954
• Est. completion date: February 13, 2015
• Est. primary completion date: February 13, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Prevention

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight		3 Months, 6 Months, 12 Months
Primary	Change in Body Mass Index		3 Months, 6 Months, 12 Months
Primary	Change in hip-to-waist ratio measurements		3 Months, 6 Months, 12 Months