Translational Obesity Research (Pathways)
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
Obesity |
Behavioral: Pathways |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Translational Research: Applying Drug Prevention to Obesity Prevention |
- Food Intake [ Time Frame: 9 month posttest, 21 month follow-up, 33 month follow-up ] [ Designated as safety issue: No ]
- Physical Activity [ Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest ] [ Designated as safety issue: No ]
- Body Mass Index [ Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest ] [ Designated as safety issue: No ]
- Executive Cognitive Function [ Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest ] [ Designated as safety issue: No ]
- Stress [ Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest ] [ Designated as safety issue: No ]
- Attitudes toward healthy eating and physical activity [ Time Frame: baseline, 9 month posttest, 21 month posttest, 33 month posttest ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
Receives universal school-based health promotion curriculum
|
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
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 4th grade students at participating schools
Exclusion Criteria:
- None
Contacts and Locations| 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 |
More Information
No publications provided by University of Southern California
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mary Ann Pentz, University of Southern California |
| ClinicalTrials.gov Identifier: | NCT00787709 History of Changes |
| Other Study ID Numbers: | HS-08-00437, RO1HD052107-0182 |
| Study First Received: | November 6, 2008 |
| Last Updated: | November 6, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Southern California:
|
Obesity prevention Health promotion School based curriculum |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013