Diabetes Prevention and Control in the Workplace: A Pilot Study

This study is currently recruiting participants.

Verified by State University of New York - Upstate Medical University, August 2008

First Received: August 19, 2008 Last Updated: August 20, 2008 History of Changes

Sponsors and Collaborators:	State University of New York - Upstate Medical University County of Onondaga, NYS NYS Department of Health
Information provided by:	State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:	NCT00739336

Purpose

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.

Condition	Intervention
Type 2 Diabetes Mellitus	Behavioral: Diabetes Prevention and Control

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	Diabetes Prevention and Control in the Workplace: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:

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

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 ]

Estimated Enrollment:	100
Study Start Date:	July 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 1: 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.	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.
A, 2: No Intervention This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.

Arms

Assigned Interventions

A, 1: 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.

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.

A, 2: No Intervention

This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult employees of Onondaga County

Exclusion Criteria:

Not an employee of Onondaga County
Less than age 18

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739336

Contacts

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

Locations

United States, New York
SUNY Upstate Medical University	Recruiting
Syracuse, New York, United States, 13210
Principal Investigator: Ruth S Weinstock, MD, PhD

Sponsors and Collaborators

State University of New York - Upstate Medical University

County of Onondaga, NYS

NYS Department of Health

Investigators

Principal Investigator:

Ruth S Weinstock, MD, PhD

State University of New York - Upstate Medical University

More Information

No publications provided

Responsible Party:	SUNY Upstate Medical University ( Ruth S. Weinstock MD PhD )
Study ID Numbers:	IRB#5657, NYSDOH Contract# C021750, Onondaga Cty,NY Contract#39407
Study First Received:	August 19, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00739336 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:

diabetes mellitus
obesity
prevention

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009