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临床试验/NCT00787709
NCT00787709已完成不适用

Translational Research: Applying Drug Prevention to Obesity Prevention

University of Southern California2 个研究点 分布在 1 个国家目标入组 1,005 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,005
试验地点
2
主要终点
Food Intake

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 4th grade students at participating schools

排除标准

  • 未提供

结局指标

主要结局

Food Intake

时间窗: 9 month posttest, 21 month follow-up, 33 month follow-up

Physical Activity

时间窗: baseline, 9 month posttest, 21 month posttest, 33 month posttest

Body Mass Index

时间窗: baseline, 9 month posttest, 21 month posttest, 33 month posttest

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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