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Diabetes Prevention and Control in the Workplace: A Pilot Study

This study has been completed.
Sponsor:
Collaborators:
County of Onondaga, NYS
NYS Department of Health
Information provided by (Responsible Party):
Ruth Weinstock, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00739336
First received: August 19, 2008
Last updated: August 11, 2016
Last verified: August 2016
  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: Open Label
Primary Purpose: Prevention
Official Title: Diabetes Prevention and Control in the Workplace: A Pilot Study

Further study details as provided by 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 19, 2008
Results First Received: June 1, 2015
Last Updated: August 11, 2016

Keywords provided by 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

ClinicalTrials.gov processed this record on February 24, 2017