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Trial of Activity for Adolescent Girls (TAAG)

Trial of Activity for Adolescent Girls (TAAG)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006409
Acronym
TAAG
Enrollment
8727
Registered
2000-10-13
Start date
2000-09-30
Completion date
2008-08-31
Last updated
2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Obesity

Brief summary

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.

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.

Interventions

BEHAVIORALTrial 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 14 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)Post-2 year intervention

Participant flow

Participants by arm

ArmCount
6th-grade/2003 - Intervention
Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
865
6th-grade/2003 - Control
Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
856
8th-grade/2005 - Intervention
Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)
1,791
8th-grade/2005 - Control
Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)
1,713
8th-grade/2006 - Intervention
Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)
1,726
8th-grade/2006 - Control
Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)
1,776
Total8,727

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
BaselineProtocol Violation48700000
Post-2 Year InterventionProtocol Violation0025116800
Post-3 Year InterventionProtocol Violation00006262

Baseline characteristics

Characteristic6th-grade/2003 - Control8th-grade/2005 - Intervention8th-grade/2005 - Control8th-grade/2006 - Intervention8th-grade/2006 - Control6th-grade/2003 - InterventionTotal
Age, Categorical
<=18 years
856 Participants1791 Participants1713 Participants1726 Participants1776 Participants865 Participants8727 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Continuous11.98 years
STANDARD_DEVIATION 0.55
14.00 years
STANDARD_DEVIATION 0.53
13.99 years
STANDARD_DEVIATION 0.52
13.97 years
STANDARD_DEVIATION 0.49
13.99 years
STANDARD_DEVIATION 0.49
11.94 years
STANDARD_DEVIATION 0.49
11.96 years
STANDARD_DEVIATION 0.52
Sex: Female, Male
Female
856 Participants1791 Participants1713 Participants1726 Participants1776 Participants865 Participants8727 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 8650 / 8560 / 1,7910 / 1,7130 / 1,7260 / 1,776
serious
Total, serious adverse events
0 / 8650 / 8560 / 1,7910 / 1,7130 / 1,7260 / 1,776

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
8th-grade/2005 - InterventionMET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)136.5 Minutes of MET-weighted MVPA˙Standard Error 5.16
8th-grade/2005 - ControlMET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)136.9 Minutes of MET-weighted MVPA˙Standard Error 5.16
Primary

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

ArmMeasureValue (MEAN)Dispersion
8th-grade/2006 - InterventionMET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)136.4 Minutes of MET-weighted MVPA˙Standard Error 7.31
8th-grade/2006 - ControlMET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)125.5 Minutes of MET-weighted MVPA˙Standard Error 7.31

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026