NCT00123500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,202

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

4.9 years

First QC Date

July 21, 2005

Last Update Submit

March 24, 2017

Conditions

ObesityCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Body mass index (BMI)

    Measured at the end of the second year of intervention

Secondary Outcomes (1)

  • 24-hour dietary recall

    Measured at baseline (Fall 2006) and follow-up (Fall 2008)

Study Arms (2)

1

ACTIVE COMPARATOR

Worksite Intervention

Behavioral: DietBehavioral: Physical ActivityBehavioral: Environment

2

PLACEBO COMPARATOR

Control Group

Other: Control Group

Interventions

DietBEHAVIORAL

Diet

1
Physical ActivityBEHAVIORAL

Physical Activity

1
EnvironmentBEHAVIORAL

Environment

1
Control GroupOTHER

Control Group

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to participate in routine physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

ObesityCardiovascular Diseases

Interventions

DietExerciseEnvironmentControl Groups

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public HealthEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Larry Webber, PhD

    Tulane University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 25, 2005

Study Start

September 1, 2004

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

US(1)