Translational Obesity Research

Study Overview
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Brief Summary
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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.

Official Title
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Translational Research: Applying Drug Prevention to Obesity Prevention

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Pathways


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4th grade students at participating schools Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Intake |  | 9 month posttest, 21 month follow-up, 33 month follow-up | 
| Physical Activity |  | baseline, 9 month posttest, 21 month posttest, 33 month posttest | 
| Body Mass Index |  | baseline, 9 month posttest, 21 month posttest, 33 month posttest | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity prevention, Health promotion, School based curriculum