Diabetes Prevention and Control in the Workplace: A Pilot Study

August 11, 2016 updated by: Ruth Weinstock, State University of New York - Upstate Medical University
This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult employees of Onondaga County

Exclusion Criteria:

  • Not an employee of Onondaga County
  • Less than age 18

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A, 1
Intervention: Immediate 3 month program
Behavioral: Diabetes Prevention and Control
The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings.
No Intervention: A, 2
Wait-List Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 3 months
Weight loss in kg
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Glucose Level
Time Frame: Baseline
Fasting glucose (mg/dL)
Baseline
Fasting Lipid Profile
Time Frame: Baseline
LDL-cholesterol (mg/dL)
Baseline
Hemoglobin A1c
Time Frame: baseline
hemoglobin A1c (%)
baseline
Waist Circumference
Time Frame: baseline, 3, 6, 12 months
baseline, 3, 6, 12 months
Questionnaires
Time Frame: baseline, 3, 6, 12 months
baseline, 3, 6, 12 months

Collaborators and Investigators

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

Sponsor

State University of New York - Upstate Medical University

Collaborators

County of Onondaga, NYS
NYS Department of Health

Investigators

  • Principal Investigator: Ruth S Weinstock, MD, PhD, State University of New York - Upstate Medical University

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

July 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#5657
  • NYSDOH Contract# C021750
  • Onondaga Cty,NY Contract#39407

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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