NCT00787709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,005

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2014

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3.9 years

First QC Date

November 6, 2008

Last Update Submit

March 22, 2017

Conditions

Obesity

Keywords

Obesity preventionHealth promotionSchool based curriculum

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Pathways

2

NO INTERVENTION

Control group of students who do not receive the intervention

Interventions

PathwaysBEHAVIORAL

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

1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th grade students at participating schools

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Alhambra, California, 91803, United States

Location

Related Publications (6)

  • 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.

    PMID: 31509018DERIVED

  • 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.

    PMID: 31404882DERIVED

  • 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.

    PMID: 27477059DERIVED

  • 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.

    PMID: 23739725DERIVED

  • 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.

    PMID: 23345012DERIVED

  • 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.

    PMID: 22408581DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary Ann Pentz, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Nathaniel R Riggs, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

May 1, 2007

Primary Completion

April 1, 2011

Study Completion

February 28, 2014

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(1)