Diabetes Prevention and Control in the Workplace: A Pilot Study

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Diabetes Prevention and Control in the Workplace: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00739336
• Other study ID #: IRB#5657
• Secondary ID: NYSDOH Contract#
• Status: Active, not recruiting
• Phase: N/A
• First received: August 19, 2008
• Last updated: December 29, 2009
• Start date: July 2008

Study information

• Verified date: December 2009
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult employees of Onondaga County

Exclusion Criteria:

• Not an employee of Onondaga County

• Less than age 18

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	County of Onondaga, NYS, NYS Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		Baseline, 3, 6, 12 months	No
Secondary	Fasting glucose level		Baseline, 3, 6, 12 months	No
Secondary	Fasting lipid profile		Baseline, 3, 6, 12 months	No
Secondary	hemoglobin A1c		baseline, 3,6, 12 months	No
Secondary	waist circumference		baseline, 3, 6, 12 months	No
Secondary	questionnaires		baseline, 3, 6, 12 months	No