Clinical trial NCT00787709: Translational Obesity Research
Official title: Translational Research: Applying Drug Prevention to Obesity Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity prevention
Health promotion
School based curriculum
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-11-07
Enrollment: 1005
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 4th grade students at participating schools

Exclusion Criteria:

* None

Primary outcomes:
measure: Food Intake
timeFrame: 9 month posttest, 21 month follow-up, 33 month follow-up
measure: Physical Activity
timeFrame: baseline, 9 month posttest, 21 month posttest, 33 month posttest
measure: Body Mass Index
timeFrame: baseline, 9 month posttest, 21 month posttest, 33 month posttest
Secondary outcomes:
measure: Executive Cognitive Function
timeFrame: baseline, 9 month posttest, 21 month posttest, 33 month posttest
measure: Stress
timeFrame: baseline, 9 month posttest, 21 month posttest, 33 month posttest
measure: Attitudes toward healthy eating and physical activity
timeFrame: baseline, 9 month posttest, 21 month posttest, 33 month posttest
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Mary Ann Pentz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Nathaniel R Riggs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.