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OpenTrials
Completed

NCT Number: NCT00787709

Translational Obesity Research

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Alhambra, California, 91803, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4th grade students at participating schools

Exclusion criteria

  • None

Treatment and study plan

PATHWAYS

Behavioral

3-year, 30 lesson, School-based universal health promotion curriculum with parent component.

Primary outcomes

  1. Food Intake

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

  2. Physical Activity

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

  3. Body Mass Index

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

Secondary outcomes

  1. Executive Cognitive Function

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

  2. Stress

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

  3. Attitudes toward healthy eating and physical activity

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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Translational Research: Applying Drug Prevention to Obesity Prevention

Acronym: Pathways

Important dates

Study start
2007
Primary completion
2011
Study completion
2014
First posted
Nov 7, 2008
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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