Translational Obesity Research (Pathways)

University of Southern California

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Pathways

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00787709

HS-08-00437

R01HD052107 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,005 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 4th grade students at participating schools

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,005 participants in 2 patient groups

1

Experimental group

Description:

Receives Pathways universal school-based health promotion curriculum from 4th-6th grade

Treatment:

Behavioral: Pathways

2

No Intervention group

Description:

Control group of students who do not receive the intervention