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Completed

NCT Number: NCT00006409

Trial of Activity for Adolescent Girls (TAAG)

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.

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Key information

About this study

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.

The randomized trial of 36 middle schools (6 per field site) will collect data by two-cross sectional samples, one taken at the sixth grade (at least 1,728 girls) in the Spring of 2003 and the other taken at the eighth grade (at least 3,456 girls) in the Spring of 2005. Follow-up data collection will also occur at the eighth grade in the Spring of 2006.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Student exclusion criteria:

  • 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

Treatment and study plan

Trial of Activity for Adolescent Girls (TAAG)

Behavioral

Intervention activities were designed to create (1) environmental and organizational changes supportive of physical activity and (2) cues, messages, and incentives to be more active. The intervention was designed to establish more opportunities, improve social support and norms, and increase self-efficacy, outcome expectations, and behavioral skills to foster greater moderate-vigorous physical activity (MVPA). An innovative feature of TAAG was linking school and community agencies to promote activity programs for girls. Finally, a TAAG Program Champion component was developed to foster sustainability after the 2-year staff-directed intervention. TAAG investigators recruited and trained Program Champions during the staff-directed intervention phase to promote maintenance of the program.

Primary outcomes

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

    Time frame: Post-2 year intervention

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

    Time frame: Post-3 year intervention

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: TAAG

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Oct 13, 2000
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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