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Wellness Program for Elementary School Personnel

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00123500
First received: July 21, 2005
Last updated: March 24, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Obesity Cardiovascular Diseases Behavioral: Diet Behavioral: Physical Activity Behavioral: Environment Other: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: ACTION! Wellness Program for Elementary School Personnel

Further study details as provided by Larry S. Webber, Tulane University School of Public Health and Tropical Medicine:

Primary Outcome Measures:
  • Body mass index (BMI) [ Time Frame: Measured at the end of the second year of intervention ]

Secondary Outcome Measures:
  • 24-hour dietary recall [ Time Frame: Measured at baseline (Fall 2006) and follow-up (Fall 2008) ]

Enrollment: 1202
Study Start Date: September 2004
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Worksite Intervention
Behavioral: Diet
Diet
Behavioral: Physical Activity
Physical Activity
Behavioral: Environment
Environment
Placebo Comparator: 2
Control Group
Other: Control Group
Control Group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00123500

Locations
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University School of Public Health and Tropical Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Larry Webber, PhD Tulane University
  More Information

Responsible Party: Larry S. Webber, Professor, Tulane University School of Public Health and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00123500     History of Changes
Obsolete Identifiers: NCT00122967
Other Study ID Numbers: 234
R01HL079509 ( U.S. NIH Grant/Contract )
Study First Received: July 21, 2005
Last Updated: March 24, 2017

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 25, 2017