Translational Obesity Research (Pathways)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Southern California.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00787709
First received: November 6, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • 4th grade students at participating schools

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787709

Contacts
Contact: Mary Ann Pentz, PhD 626-457-6691 pentz@usc.edu
Contact: Nathaniel R Riggs, PhD 626-457-6687 nriggs@usc.edu

Locations
United States, California
University of Southern California Recruiting
Alhambra, California, United States, 91803
Contact: Mary Ann Pentz, PhD    626-457-6691    pentz@usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
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 September 18, 2014