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临床试验/NCT00006409
NCT00006409已完成2 期

Trial of Activity for Adolescent Girls (TAAG)

University of North Carolina, Chapel Hill0 个研究点目标入组 8,727 人开始时间: 2000年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
8,727
主要终点
MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)

研究概览

简要总结

To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8.

详细描述

BACKGROUND:

The Report of the Surgeon General on Physical Activity and Health (USDHHS, 1996) emphasized that regular physical activity has important health benefits including reducing the risk of heart disease, and helping to treat and prevent high blood pressure, high cholesterol, and diabetes, and to prevent osteoporosis and colon cancer. In addition, physical activity helps control weight, reduces feelings of depression and anxiety, and promotes psychological well being. Inactivity increases with age and is more common among women than men and among those with lower income, less education, and in minorities (USDHHS, 1996). Even though adolescents are more active than adults, many do not engage in recommended levels of physical activity, and participation declines with age throughout adolescence, especially in girls (USDHHS, 1996; CDC, 1997). Fourteen percent of teenage girls get no regular exercise, twice the percentage as for boys. The proportion of adolescent girls who participate in regular vigorous physical activity declines dramatically each year they are in high school, from 61 percent among 9th graders to 41percent among 12th grade girls. In high school, enrollment for girls in daily physical education classes dropped from 41 percent in 1991 to 25 percent in 1995. Both the CDC report (1997) and the Surgeon General's Report (USDHHS, 1996) recommended the need for research testing the effectiveness of a coordinated school-based physical activity intervention linked to community agency programs to increase physical activity by adolescent girls.

The study is the result of a Request for Applications released in January, 2000. Awards were made in September 2000.

DESIGN NARRATIVE:

The purpose of the multicenter randomized trial is to test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in middle school girls (i.e., in grades 6-8). The interventions will provide skills-building, supportive environments, and opportunities for participation in physical activity during and outside of the school day. Phase 1 will be 24 months for protocol development and pilot work, Phase II is 44 months for two years of intervention and one year of follow-up, and Phase III is 4 months for close out of the Study Centers, and 16 months for the Coordinating Center to collaboratively analyze and report the results.

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

年龄范围
12 Years 至 14 Years(Child)
性别
Female
接受健康志愿者
否

入选标准

  • •School inclusion criteria:
  • •Public middle schools in which a majority of students lived in the surrounding community
  • •Enrollment of at least 90 8th-grade girls
  • •Yearly withdrawal rates less than 28%
  • •At least one semester of physical education required for each grade
  • •Willingness to sign a memorandum of understanding and accept random assignment of the school

排除标准

  • •Limited English-speaking skills
  • •Unable to participate in physical education classes due to a medical condition or disability
  • •Contraindications for participating in a submaximal exercise test

研究组 & 干预措施

Control group

No Intervention

School-based intervention

Experimental

TAAG health education included six lessons in each of 7th and 8th grades designed to enhance behavioral skills known to influence physical activity. TAAG physical education classes promoted moderate-vigorous physical activity for at least 50% of class time and encouraged teachers to promote physical activity outside of class. In conjunction with community partners, programs that were promoted outside of school included Dance Dance Revolution, after-school step aerobics class, before-school open gym, basketball camp, touch football, and weekend canoe programs. TAAG promotions used a social marketing approach to promote awareness of and participation in activities through media and promotional events.

干预措施: Trial of Activity for Adolescent Girls (TAAG) (Behavioral)

结局指标

主要结局

MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)

时间窗: Post-3 year intervention

MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)

时间窗: Post-2 year intervention

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

June Stevens, PhD

Distinguished Professor, Departments of Nutrition and Epidemiology

University of North Carolina, Chapel Hill

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