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Translational Obesity Research

Translational Research: Applying Drug Prevention to Obesity Prevention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00787709
Acronym
Pathways
Enrollment
1005
Registered
2008-11-07
Start date
2007-05-31
Completion date
2014-02-28
Last updated
2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity prevention, Health promotion, School based curriculum

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.

Interventions

BEHAVIORALPathways

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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 4th grade students at participating schools

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Food Intake9 month posttest, 21 month follow-up, 33 month follow-up
Physical Activitybaseline, 9 month posttest, 21 month posttest, 33 month posttest
Body Mass Indexbaseline, 9 month posttest, 21 month posttest, 33 month posttest

Secondary

MeasureTime frame
Executive Cognitive Functionbaseline, 9 month posttest, 21 month posttest, 33 month posttest
Stressbaseline, 9 month posttest, 21 month posttest, 33 month posttest
Attitudes toward healthy eating and physical activitybaseline, 9 month posttest, 21 month posttest, 33 month posttest

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026