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Trial of Activity for Adolescent Girls (TAAG)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00006409
First received: October 12, 2000
Last updated: April 26, 2010
Last verified: April 2010

October 12, 2000
April 26, 2010
September 2000
August 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00006409 on ClinicalTrials.gov Archive Site
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Trial of Activity for Adolescent Girls (TAAG)
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Heart Diseases
  • Obesity
Behavioral: Trial of Activity for Adolescent Girls (TAAG)
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.
  • Experimental: School-based intervention
    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.
    Intervention: Behavioral: Trial of Activity for Adolescent Girls (TAAG)
  • No Intervention: Control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8727
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Female
12 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00006409
934, U01HL066845
Yes
June Stevens, Principal Investigator, University of North Carolina at Chapel Hill
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: John Elder San Diego State University
Principal Investigator: Timothy Lohman University of Arizona
Principal Investigator: Leslie Lytle University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Russell Pate University of South Carolina
Principal Investigator: June Stevens University of North Carolina
Principal Investigator: Larry Webber Tulane University
Principal Investigator: Deborah Young Johns Hopkins University
University of North Carolina, Chapel Hill
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP