Translational Obesity Research

NCT ID: NCT00787709

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1005 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2014-02-28

Brief Summary

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Receives Pathways universal school-based health promotion curriculum from 4th-6th grade

Group Type: EXPERIMENTAL

Pathways

Intervention Type: BEHAVIORAL

3-year, 30 lesson, School-based universal health promotion curriculum with parent component.

2

Control group of students who do not receive the intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pathways

3-year, 30 lesson, School-based universal health promotion curriculum with parent component.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 4th grade students at participating schools

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Ann Pentz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Nathaniel R Riggs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Alhambra, California, United States

Countries

United States

References

Cappelli C, Pike JR, Christodoulou G, Riggs NR, Warren CM, Pentz MA. The effect of sensation seeking on alcohol use among middle school students: a latent state-trait analysis. Am J Drug Alcohol Abuse. 2020 May 3;46(3):316-324. doi: 10.1080/00952990.2019.1660885. Epub 2019 Sep 11.

Reference Type: DERIVED

PMID: 31509018 (View on PubMed)

Cappelli C, Pike JR, Riggs NR, Warren CM, Pentz MA. Executive function and probabilities of engaging in long-term sedentary and high calorie/low nutrition eating behaviors in early adolescence. Soc Sci Med. 2019 Sep;237:112483. doi: 10.1016/j.socscimed.2019.112483. Epub 2019 Aug 7.

Reference Type: DERIVED

PMID: 31404882 (View on PubMed)

Warren C, Riggs N, Pentz MA. Executive function mediates prospective relationships between sleep duration and sedentary behavior in children. Prev Med. 2016 Oct;91:82-88. doi: 10.1016/j.ypmed.2016.07.024. Epub 2016 Jul 29.

Reference Type: DERIVED

PMID: 27477059 (View on PubMed)

Little MA, Riggs NR, Shin HS, Tate EB, Pentz MA. The effects of teacher fidelity of implementation of pathways to health on student outcomes. Eval Health Prof. 2015 Mar;38(1):21-41. doi: 10.1177/0163278713489879. Epub 2013 Jun 4.

Reference Type: DERIVED

PMID: 23739725 (View on PubMed)

Pentz MA, Riggs NR. Longitudinal relationships of executive cognitive function and parent influence to child substance use and physical activity. Prev Sci. 2013 Jun;14(3):229-37. doi: 10.1007/s11121-012-0312-3.

Reference Type: DERIVED

PMID: 23345012 (View on PubMed)

Pentz MA, Spruijt-Metz D, Chou CP, Riggs NR. High calorie, low nutrient food/beverage intake and video gaming in children as potential signals for addictive behavior. Int J Environ Res Public Health. 2011 Dec;8(12):4406-24. doi: 10.3390/ijerph8124406. Epub 2011 Nov 29.

Reference Type: DERIVED

PMID: 22408581 (View on PubMed)

Other Identifiers

R01HD052107

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS-08-00437

Identifier Type: -

Identifier Source: org_study_id