Wellness Program for Elementary School Personnel

NCT ID: NCT00123500

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Obesity Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Worksite Intervention

Group Type ACTIVE_COMPARATOR

Diet

Intervention Type BEHAVIORAL

Diet

Physical Activity

Intervention Type BEHAVIORAL

Physical Activity

Environment

Intervention Type BEHAVIORAL

Environment

2

Control Group

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type OTHER

Control Group

Interventions

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Diet

Diet

Intervention Type BEHAVIORAL

Physical Activity

Physical Activity

Intervention Type BEHAVIORAL

Environment

Environment

Intervention Type BEHAVIORAL

Control Group

Control Group

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Tulane University School of Public Health and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Larry S. Webber

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Larry Webber, PhD

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

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Tulane University

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL079509

Identifier Type: NIH

Identifier Source: secondary_id

View Link

234

Identifier Type: -

Identifier Source: org_study_id

NCT00122967

Identifier Type: -

Identifier Source: nct_alias

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