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Diabetes Prevention and Control in the Workplace: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739336
First Posted: August 21, 2008
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
County of Onondaga, NYS
NYS Department of Health
Information provided by (Responsible Party):
Ruth Weinstock, State University of New York - Upstate Medical University
  Purpose
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.

Condition Intervention
Type 2 Diabetes Mellitus Behavioral: Diabetes Prevention and Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Diabetes Prevention and Control in the Workplace: A Pilot Study

Further study details as provided by Ruth Weinstock, State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Body Weight [ Time Frame: 3 months ]
    Weight loss in kg


Secondary Outcome Measures:
  • Fasting Glucose Level [ Time Frame: Baseline ]
    Fasting glucose (mg/dL)

  • Fasting Lipid Profile [ Time Frame: Baseline ]
    LDL-cholesterol (mg/dL)

  • Hemoglobin A1c [ Time Frame: baseline ]
    hemoglobin A1c (%)

  • Waist Circumference [ Time Frame: baseline, 3, 6, 12 months ]
  • Questionnaires [ Time Frame: baseline, 3, 6, 12 months ]

Enrollment: 45
Study Start Date: July 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult employees of Onondaga County

Exclusion Criteria:

  • Not an employee of Onondaga County
  • Less than age 18
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739336


Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
County of Onondaga, NYS
NYS Department of Health
Investigators
Principal Investigator: Ruth S Weinstock, MD, PhD State University of New York - Upstate Medical University
  More Information

Publications:
Responsible Party: Ruth Weinstock, Distinguished Service Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00739336     History of Changes
Other Study ID Numbers: IRB#5657
NYSDOH Contract# C021750
Onondaga Cty,NY Contract#39407
First Submitted: August 19, 2008
First Posted: August 21, 2008
Results First Submitted: June 1, 2015
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016
Last Verified: August 2016

Keywords provided by Ruth Weinstock, State University of New York - Upstate Medical University:
diabetes mellitus
obesity
prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases