This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment diabetes prevention and control
Sponsor State University of New York - Upstate Medical University
Collaborator County of Onondaga, NYS
Start date July 2008
End date February 2010
Trial size 100 participants
Trial identifier NCT00739336, IRB#5657, NYSDOH Contract# C021750, Onondaga Cty,NY Contract#39407


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
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)
This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.

Primary Outcomes

Body weight
time frame: Baseline, 3, 6, 12 months

Secondary Outcomes

Fasting glucose level
time frame: Baseline, 3, 6, 12 months
Fasting lipid profile
time frame: Baseline, 3, 6, 12 months
hemoglobin A1c
time frame: baseline, 3,6, 12 months
waist circumference
time frame: baseline, 3, 6, 12 months
time frame: baseline, 3, 6, 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult employees of Onondaga County Exclusion Criteria: - Not an employee of Onondaga County - Less than age 18

Additional Information

Official title Diabetes Prevention and Control in the Workplace: A Pilot Study
Principal investigator Ruth S Weinstock, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by State University of New York - Upstate Medical University.