Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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. The investigators 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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diabetes Prevention and Control in the Workplace: A Pilot Study

Resource links provided by NLM:


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 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: A, 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
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: Ruth S. Weinstock MD PhD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00739336     History of Changes
Other Study ID Numbers: IRB#5657, NYSDOH Contract# C021750, Onondaga Cty,NY Contract#39407
Study First Received: August 19, 2008
Last Updated: December 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
diabetes mellitus
obesity
prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014