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Wellness Program for Elementary School Personnel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123500
Recruitment Status : Completed
First Posted : July 25, 2005
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Larry S. Webber, Tulane University School of Public Health and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE July 21, 2005
First Posted Date  ICMJE July 25, 2005
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE September 2004
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
Body mass index (BMI) [ Time Frame: Measured at the end of the second year of intervention ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
24-hour dietary recall [ Time Frame: Measured at baseline (Fall 2006) and follow-up (Fall 2008) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Wellness Program for Elementary School Personnel
Official Title  ICMJE ACTION! Wellness Program for Elementary School Personnel
Brief Summary The goal of the project is to develop, implement, and evaluate, through a randomized controlled trial at a worksite, an intervention to promote increased physical activity behavior and healthier eating behavior to reduce overweight and obesity among elementary school personnel.
Detailed Description

BACKGROUND:

The dramatic increase in the prevalence of overweight and obesity among adults in the United States during the past two decades is related to increased cardiovascular disease, hypertension, dyslipidemia, diabetes, and other chronic diseases. With 63.9% of working-age adults employed, worksites are targets for prevention and intervention programs to control overweight and obesity. Worksite interventions have the potential to reach a large number of individuals in a common and shared environment.

DESIGN NARRATIVE:

This is a group-randomized trial involving 20 elementary schools in Jefferson Parish public schools. Schools will be the unit of randomization; 10 schools will be randomly allocated to implement the intervention, and 10 schools will serve as controls. The primary aim of the program is to reduce mean body weight. Secondary aims relate to changes at both the individual level and the environmental level. The intervention will address the two major determinants of overweight and obesity: physical activity and diet. A School Wellness Committee at each site will be instrumental in identifying and implementing components of the intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Cardiovascular Diseases
Intervention  ICMJE
  • Behavioral: Diet
    Diet
  • Behavioral: Physical Activity
    Physical Activity
  • Behavioral: Environment
    Environment
  • Other: Control Group
    Control Group
Study Arms  ICMJE
  • Active Comparator: 1
    Worksite Intervention
    Interventions:
    • Behavioral: Diet
    • Behavioral: Physical Activity
    • Behavioral: Environment
  • Placebo Comparator: 2
    Control Group
    Intervention: Other: Control Group
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2013)
1202
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults with no contraindications to participating in an intervention to improve eating and exercise behaviors
  • Healthy adults with no contraindications to participating in any of the measurement procedures

Exclusion Criteria:

  • Inability to participate in routine physical activity
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123500
Other Study ID Numbers  ICMJE 234
R01HL079509 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Larry S. Webber, Tulane University School of Public Health and Tropical Medicine
Study Sponsor  ICMJE Tulane University School of Public Health and Tropical Medicine
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Larry Webber, PhD Tulane University
PRS Account Tulane University
Verification Date March 2017

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