Expired Study
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New Orleans, Louisiana 70112


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.


Study summary:

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.


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


Study is Available At:


Original ID:

234


NCT ID:

NCT00123500


Secondary ID:

R01HL079509


Study Acronym:


Brief Title:

Wellness Program for Elementary School Personnel


Official Title:

ACTION! Wellness Program for Elementary School Personnel


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Tulane University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1202


Enrollment Type:

Actual


Overall Contact Information

Official Name:Larry Webber, PhD
Principal Investigator
Tulane University

Study Dates

Start Date:September 2004
Completion Date:August 2009
Completion Type:Actual
Primary Completion Date:August 2009
Primary Completion Type:Actual
Verification Date:March 2017
Last Changed Date:March 24, 2017
First Received Date:July 21, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:24-hour dietary recall
Time Frame:Measured at baseline (Fall 2006) and follow-up (Fall 2008)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Body mass index (BMI)
Time Frame:Measured at the end of the second year of intervention
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Diet
Description:Diet
Arm Name:1
Intervention Type:Behavioral
Name:Physical Activity
Description:Physical Activity
Arm Name:1
Intervention Type:Behavioral
Name:Environment
Description:Environment
Arm Name:1
Intervention Type:Other
Name:Control Group
Description:Control Group
Arm Name:2

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:Control Group
Study Arm Type:Active Comparator
Arm Name:1
Description:Worksite Intervention

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Tulane University School of Public Health and Tropical Medicine
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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