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Diabetes Prevention and Control in the Workplace: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00739336
Recruitment Status : Completed
First Posted : August 21, 2008
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Diabetes Prevention and Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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


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

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

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

  4. Waist Circumference [ Time Frame: baseline, 3, 6, 12 months ]
  5. Questionnaires [ Time Frame: baseline, 3, 6, 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Ruth S Weinstock, MD, PhD State University of New York - Upstate Medical University
More Information
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Publications:

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Responsible Party: Ruth Weinstock, Distinguished Service Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00739336    
Other Study ID Numbers: IRB#5657
NYSDOH Contract# C021750
Onondaga Cty,NY Contract#39407
First Posted: August 21, 2008    Key Record Dates
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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases