Wellness Program for Elementary School Personnel

Obesity Clinical Trial

Official title:

ACTION! Wellness Program for Elementary School Personnel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123500
• Other study ID #: 234
• Secondary ID: R01HL079509
• Status: Completed
• Phase: N/A
• First received: July 21, 2005
• Last updated: March 24, 2017
• Start date: September 2004
• Est. completion date: August 2009

Study information

• Verified date: March 2017
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00122967

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1202
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Intervention

Behavioral:
• Diet
Diet
• Physical Activity
Physical Activity
• Environment
Environment

Other:
• Control Group
Control Group

Locations

Country	Name	City	State
United States	Tulane University	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University School of Public Health and Tropical Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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