Diabetes Prevention and Control in the Workplace: A Pilot Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 19, 2008

Last Updated Date

August 20, 2008

Start Date ^†

July 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

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

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Diabetes Prevention and Control in the Workplace: A Pilot Study

Official Title ^†

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. We will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Parallel Assignment

Condition ^†

Type 2 Diabetes Mellitus

Intervention ^†

Behavioral: Diabetes Prevention and Control

Study Arms / Comparison Groups

Experimental: 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.
No Intervention: This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

100

Completion Date

Estimated Primary Completion Date

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

Eligibility Criteria ^†

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 ^††

Contact: Ruth S Weinstock, MD PhD	315-464-5740	weinstor@upstate.edu
Contact: Paula Trief, PhD	315-464-3121	triefp@upstate.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739336

Responsible Party

Ruth S. Weinstock MD PhD, SUNY Upstate Medical University

Secondary IDs ^††

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

Study Sponsor ^†

State University of New York - Upstate Medical University

Collaborators ^††

County of Onondaga, NYS
NYS Department of Health

Investigators ^†

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

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.