Wellness Program for Elementary School Personnel

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00123500

First received: July 21, 2005

Last updated: February 10, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2005

Last Updated Date

February 10, 2009

Start Date ^ICMJE

September 2004

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Body mass index (BMI) [ Time Frame: Measured at the end of the second year of intervention ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00123500 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

24-hour dietary recall [ Time Frame: Measured at baseline (Fall 2006) and follow-up (Fall 2008) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Active, not recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

August 2009

Estimated 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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00123500

Other Study ID Numbers ^ICMJE

234, R01 HL079509

Has Data Monitoring Committee

Yes

Responsible Party

Larry S. Webber, PhD, Tulane Univeristy School of Public Health and Tropical Medicine

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Larry Webber, PhD

Tulane University

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

February 2009

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

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