Back to resultsDiabetes Prevention and Control in the Workplace: A Pilot Study
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention and Control
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring diabetes mellitus, obesity, prevention
Eligibility Criteria
Inclusion Criteria:
- Adult employees of Onondaga County
Exclusion Criteria:
- Not an employee of Onondaga County
- Less than age 18
Sites / Locations
- SUNY Upstate Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A, 1
A, 2
Arm Description
Intervention: Immediate 3 month program
Wait-List Control
Outcomes
Primary Outcome Measures
Body Weight
Weight loss in kg
Secondary Outcome Measures
Fasting Glucose Level
Fasting glucose (mg/dL)
Fasting Lipid Profile
LDL-cholesterol (mg/dL)
Hemoglobin A1c
hemoglobin A1c (%)
Waist Circumference
Questionnaires
Full Information
NCT ID
NCT00739336
First Posted
August 19, 2008
Last Updated
August 11, 2016
Sponsor
State University of New York - Upstate Medical University
Collaborators
County of Onondaga, NYS, NYS Department of Health
1. Study Identification
Unique Protocol Identification Number
NCT00739336
Brief Title
Diabetes Prevention and Control in the Workplace: A Pilot Study
Official Title
Diabetes Prevention and Control in the Workplace: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University
Collaborators
County of Onondaga, NYS, NYS Department of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes mellitus, obesity, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A, 1
Arm Type
Experimental
Arm Description
Intervention: Immediate 3 month program
Arm Title
A, 2
Arm Type
No Intervention
Arm Description
Wait-List Control
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention and Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Weight
Description
Weight loss in kg
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fasting Glucose Level
Description
Fasting glucose (mg/dL)
Time Frame
Baseline
Title
Fasting Lipid Profile
Description
LDL-cholesterol (mg/dL)
Time Frame
Baseline
Title
Hemoglobin A1c
Description
hemoglobin A1c (%)
Time Frame
baseline
Title
Waist Circumference
Time Frame
baseline, 3, 6, 12 months
Title
Questionnaires
Time Frame
baseline, 3, 6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult employees of Onondaga County
Exclusion Criteria:
Not an employee of Onondaga County
Less than age 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth S Weinstock, MD, PhD
Organizational Affiliation
State University of New York - Upstate Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21464685
Citation
Barham K, West S, Trief P, Morrow C, Wade M, Weinstock RS. Diabetes prevention and control in the workplace: a pilot project for county employees. J Public Health Manag Pract. 2011 May-Jun;17(3):233-41. doi: 10.1097/PHH.0b013e3181fd4cf6.
Results Reference
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Diabetes Prevention and Control in the Workplace: A Pilot Study
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