Diabetes Prevention and Control in the Workplace: A Pilot Study

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by State University of New York - Upstate Medical University.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

County of Onondaga, NYS

NYS Department of Health

Information provided by:

State University of New York - Upstate Medical University

ClinicalTrials.gov Identifier:

NCT00739336

First received: August 19, 2008

Last updated: December 29, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 19, 2008

Last Updated Date

December 29, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Body weight [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Body weight [ Time Frame: Baseline, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00739336 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Fasting glucose level [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
Fasting lipid profile [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
hemoglobin A1c [ Time Frame: baseline, 3,6, 12 months ] [ Designated as safety issue: No ]
waist circumference [ Time Frame: baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
questionnaires [ Time Frame: baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Fasting glucose level [ Time Frame: Baseline, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
Fasting lipid profile [ Time Frame: Baseline, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
hemoglobin A1c [ Time Frame: baseline, 3,6, 12 and 24 months ] [ Designated as safety issue: No ]
waist circumference [ Time Frame: baseline, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
questionnaires [ Time Frame: baseline, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Diabetes Prevention and Control in the Workplace: A Pilot Study

Official Title ^ICMJE

Diabetes Prevention and Control in the Workplace: A Pilot Study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: A, 1
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.

Intervention: Behavioral: Diabetes Prevention and Control
No Intervention: A, 2
This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Not Provided

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult employees of Onondaga County

Exclusion Criteria:

Not an employee of Onondaga County
Less than age 18

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00739336

Other Study ID Numbers ^ICMJE

IRB#5657, NYSDOH Contract# C021750, Onondaga Cty,NY Contract#39407

Has Data Monitoring Committee

Responsible Party

Ruth S. Weinstock MD PhD, SUNY Upstate Medical University

Study Sponsor ^ICMJE

State University of New York - Upstate Medical University

Collaborators ^ICMJE

County of Onondaga, NYS
NYS Department of Health

Investigators ^ICMJE

Principal Investigator:

Ruth S Weinstock, MD, PhD

State University of New York - Upstate Medical University

Information Provided By

State University of New York - Upstate Medical University

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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