Trial of Activity for Adolescent Girls (TAAG)

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: Obesity; Cardiovascular Diseases; Heart Diseases

Treatments: Behavioral: Trial of Activity for Adolescent Girls (TAAG)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006409

934

U01HL066845 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,727 patients

Sex: Female

Ages: 12 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,727 participants in 2 patient groups

School-based intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Trial of Activity for Adolescent Girls (TAAG)

Control group

No Intervention group