Translational Obesity Research (Pathways)

March 22, 2017 updated by: University of Southern California

Translational Research: Applying Drug Prevention to Obesity Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1005

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alhambra, California, United States, 91803
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 4th grade students at participating schools

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Receives Pathways universal school-based health promotion curriculum from 4th-6th grade
Behavioral: Pathways
3-year, 30 lesson, School-based universal health promotion curriculum with parent component.
No Intervention: 2
Control group of students who do not receive the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Food Intake
Time Frame: 9 month posttest, 21 month follow-up, 33 month follow-up
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
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
baseline, 9 month posttest, 21 month posttest, 33 month posttest

Secondary Outcome Measures

Outcome Measure
Time Frame
Executive Cognitive Function
Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest
baseline, 9 month posttest, 21 month posttest, 33 month posttest
Stress
Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest
baseline, 9 month posttest, 21 month posttest, 33 month posttest
Attitudes toward healthy eating and physical activity
Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest
baseline, 9 month posttest, 21 month posttest, 33 month posttest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

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

Investigators

  • Principal Investigator: Mary Ann Pentz, PhD, University of Southern California
  • Principal Investigator: Nathaniel R Riggs, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

February 28, 2014

Study Registration Dates

First Submitted

November 6, 2008

First Submitted That Met QC Criteria

November 6, 2008

First Posted (Estimate)

November 7, 2008

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-08-00437
  • R01HD052107 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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