Trial of Activity for Adolescent Girls (TAAG) (TAAG)

June 29, 2015 updated by: June Stevens, PhD, University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

8727

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Post-2 year intervention
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
Post-3 year intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: John Elder, San Diego State University
  • Principal Investigator: Timothy Lohman, University of Arizona
  • Principal Investigator: Leslie Lytle, University of Minnesota
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 12, 2000

First Submitted That Met QC Criteria

October 12, 2000

First Posted (Estimate)

October 13, 2000

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 934
  • U01HL066845 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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