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临床试验/NCT00289315
NCT00289315已完成不适用

LA Health: A Prospective Study of Primary and Secondary Obesity Prevention in Children and Adolescents

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家目标入组 2,060 人开始时间: 2005年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,060
试验地点
1
主要终点
% Body Fat (Boys)

研究概览

简要总结

There is a worldwide pandemic of obesity with far-reaching consequences for the health of our nation. Obesity is the second leading cause of preventable death in the United States. Prevention of obesity, especially in children, has been deemed by public health policy makers to be one of the most important objectives for our country.

详细描述

There is a worldwide pandemic of obesity with far-reaching consequences for the health of our nation. Obesity is the second leading cause of preventable death in the United States. Prevention of obesity, especially in children, has been deemed by public health policy makers to be one of the most important objectives for our country. Obesity disproportionately affects citizens of minority and low socioeconomic status. A consensus of opinion has formed that the recently observed increased prevalence of obesity is caused by environmental and behavioral factors that favor easy access to high calorie foods and sedentary behavior. This prevention project, called LA Health, will test whether modification of these environmental and behavioral factors can prevent inappropriate weight gain in children who are enrolled in the fourth to sixth grades during Year 1. The primary aims of the LA Health project are to test the efficacy of two school-based approaches for obesity prevention. The two approaches are derived from two NIH-funded pilot studies called the HIPTeens project (a secondary prevention program) and the Wise Mind project (a primary prevention program). The study will test the efficacy of primary prevention alone and a combination of primary and secondary prevention in comparison to a no-treatment control group using a cluster randomization research design, with 18 school clusters from 9 different parishes randomly assigned to the three treatment arms. The following parishes were selected for the project: East Carroll, Madison, Franklin, East Feliciana, St. John, St. Helena, Pointe Coupee, Avoyelles, and Sabine Parishes. Thus far East Carroll, East Feliciana, St. John, Pointe Coupee, and Avoyelles Parishes have agreed to participate. We anticipate adding additional parishes in the second year of the project.The project will collaborate with a USDE funded project, LA GEAR UP, to test the relative efficacy obesity prevention programs for children who come from economically disadvantaged environments. The LA GEAR UP program is designed to enhance educational achievement. Since LA GEAR UP will be implemented in all 18 school clusters, all of the preventions intervention arms, including no-treatment, will be combined with an academic enhancement program. The study will span three years and will provide critical tests of strategies that modify the child's environment as a primary prevention strategy and provide health behavior modification via classroom instruction and internet counseling as a secondary prevention strategy. The study will also recruit a similar (but smaller) sample of students to measure changes in body weight relative to height, gender, and age over the same three-year period. This observation only control group will be studied to evaluate secular trends in changes in body weight so that body weight changes observed in the randomized trial can be interpreted within the context of stable versus unstable population changes in body weight. The results of this investigation will significantly impact public health policy related to obesity prevention in rural communities, minority communities, and in children from families that are economically disadvantaged.

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

  • Being one of the LA GEAR UP middle schools or a feeder elementary school
  • Having an enrollment of at least 100 students per school
  • All students in grades 4-6 of participating schools

排除标准

  • 未提供

研究组 & 干预措施

Arm 1

Experimental

Primary (Environmental) Prevention of Weight Gain

干预措施: Primary (Environmental) Weight Gain Prevention (Behavioral)

Arm 2

Experimental

Primary (Envrironmental) and Secondary (Behavioral) Weight Gain Prevention Program

干预措施: Primary (Environmental) Weight Gain Prevention (Behavioral)

Arm 2

Experimental

Primary (Envrironmental) and Secondary (Behavioral) Weight Gain Prevention Program

干预措施: Secondary (Behavioral) Weight Gain Prevention (Behavioral)

Arm 3

Experimental

Control - no Environmental or Behavioral Program intervention

干预措施: Control (Behavioral)

结局指标

主要结局

% Body Fat (Boys)

时间窗: Baseline and 3 years

change in percent body fat between Baseline and 3 years for boys

BMI Z-score (Boys)

时间窗: Baseline and three years

Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean

% Body Fat (Girls)

时间窗: Baseline and 3 years

change in percent body fat between Baseline and 3 years for girls

BMI Z-score (Girls)

时间窗: Baseline and three years

Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Corby K. Martin

Professor

Pennington Biomedical Research Center

研究点 (1)

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