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Clinical Trials/NCT00787709
NCT00787709
Completed
N/A

Translational Research: Applying Drug Prevention to Obesity Prevention

University of Southern California1 site in 1 country1,005 target enrollmentMay 2007
ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Southern California
Enrollment
1005
Locations
1
Primary Endpoint
Food Intake
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The proposed project takes an innovative approach to childhood obesity prevention, for which there currently no evidence-based programs, and for which results of current trials have produced mainly short-term or disappointing effects. The aim of this project is to adapt and revise parts of two nationally recognized programs for drug prevention for use with children in grades 4-6 with the express purpose of obesity prevention. The current study will attempt to promote emotion regulation, neuro-cognitive function, and social competence in order to prevent obesity. A total of 24 elementary schools from two of the largest districts in Orange County will be randomly assigned to either the obesity prevention program or control group (N=1587) 4th grade students and their parents). A cohort of students will be followed from the 4th through 6th grades. Intervention students will be administered the Pathways obesity prevention program by trained teachers. The population is ethnically diverse (36% white, 57% Hispanic, 6%Asian; 48% on free/reduced lunch programs). Self-report measures, BMI, and waist circumference will be administered at the beginning of 4th grade, and at end of 4th , 5th , and 6th grade. Teacher, administrative, and parent surveys will be administered on the same schedule to measure school environment. Program implementation will be measured by teacher self-report and research staff observations. Data will be analyzed with statistical approaches that capture effects of school and classroom, test the theoretical model of change, and evaluate developmental trends in mediators and outcomes across the three grades. Findings should be generalizable to most elementary schools, and will be used to develop evidence-based program standards for childhood obesity prevention.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
February 28, 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 4th grade students at participating schools

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Food Intake

Time Frame: 9 month posttest, 21 month follow-up, 33 month follow-up

Physical Activity

Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest

Body Mass Index

Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest

Secondary Outcomes

  • Executive Cognitive Function(baseline, 9 month posttest, 21 month posttest, 33 month posttest)
  • Stress(baseline, 9 month posttest, 21 month posttest, 33 month posttest)
  • Attitudes toward healthy eating and physical activity(baseline, 9 month posttest, 21 month posttest, 33 month posttest)

Study Sites (1)

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