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Sponsored by: |
University of Southern California |
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Information provided by: | University of Southern California |
ClinicalTrials.gov Identifier: | NCT00787709 |
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=3460 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.
Condition | Intervention |
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Obesity |
Behavioral: Pathways |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Translational Research: Applying Drug Prevention to Obesity Prevention |
Estimated Enrollment: | 2400 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Receives universal school-based health promotion curriculum
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Behavioral: Pathways
3-year, 30 lesson, School-based universal health promotion curriculum with parent component.
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2: No Intervention
Control group of students who do not receive the intervention
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Ann Pentz, PhD | 626-457-6691 | pentz@usc.edu |
Contact: Nathaniel R Riggs, PhD | 626-457-6687 | nriggs@usc.edu |
United States, California | |
University of Southern California | Recruiting |
Alhambra, California, United States, 91803 | |
Contact: Mary Ann Pentz, PhD 626-457-6691 pentz@usc.edu |
Principal Investigator: | Mary Ann Pentz, PhD | University of Southern California |
Principal Investigator: | Nathaniel R Riggs, PhD | University of Southern California |
Responsible Party: | University of Southern California ( Mary Ann Pentz ) |
Study ID Numbers: | HS-08-00437, RO1HD052107-0182 |
Study First Received: | November 6, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00787709 |
Health Authority: | United States: Institutional Review Board |
Obesity prevention Health promotion School based curriculum |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |