Translational Obesity Research

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Pathways

• Registration Number: NCT00787709
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Primary Completion: 2011-04
• Study Completion: 2014-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1005

Inclusion Criteria

• 4th grade students at participating schools

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pathways	Receives Pathways universal school-based health promotion curriculum from 4th-6th grade

Primary Outcome Measures

Name	Time	Method
Food Intake	9 month posttest, 21 month follow-up, 33 month follow-up
Physical Activity	baseline, 9 month posttest, 21 month posttest, 33 month posttest
Body Mass Index	baseline, 9 month posttest, 21 month posttest, 33 month posttest

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Alhambra, California, United States