Trial of Activity for Adolescent Girls (TAAG)

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT00006409
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 8,727
• Arms: 2
• Duration (Months): 95

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Heart Diseases; Obesity	Behavioral: Trial of Activity for Adolescent Girls (TAAG)	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 8727 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Trial of Activity for Adolescent Girls (TAAG)
• Study Start Date: Sep 1, 2000
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control group

Outcome Measures

Primary Outcome Measures

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

2. MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) [Post-3 year intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 14 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Dishman RK, Motl RW, Sallis JF, Dunn AL, Birnbaum AS, Welk GJ, Bedimo-Rung AL, Voorhees CC, Jobe JB. Self-management strategies mediate self-efficacy and physical activity. Am J Prev Med. 2005 Jul;29(1):10-8.
• Moody JS, Prochaska JJ, Sallis JF, McKenzie TL, Brown M, Conway TL. Viability of parks and recreation centers as sites for youth physical activity promotion. Health Promot Pract. 2004 Oct;5(4):438-43.
• Murray DM, Catellier DJ, Hannan PJ, Treuth MS, Stevens J, Schmitz KH, Rice JC, Conway TL. School-level intraclass correlation for physical activity in adolescent girls. Med Sci Sports Exerc. 2004 May;36(5):876-82.
• Schmitz KH, Treuth M, Hannan P, McMurray R, Ring KB, Catellier D, Pate R. Predicting energy expenditure from accelerometry counts in adolescent girls. Med Sci Sports Exerc. 2005 Jan;37(1):155-61.
• Stevens J, Murray DM, Catellier DJ, Hannan PJ, Lytle LA, Elder JP, Young DR, Simons-Morton DG, Webber LS. Design of the Trial of Activity in Adolescent Girls (TAAG). Contemp Clin Trials. 2005 Apr;26(2):223-33.
• Treuth MS, Schmitz K, Catellier DJ, McMurray RG, Murray DM, Almeida MJ, Going S, Norman JE, Pate R. Defining accelerometer thresholds for activity intensities in adolescent girls. Med Sci Sports Exerc. 2004 Jul;36(7):1259-66.

• Responsible Party: June Stevens, PhD, Distinguished Professor, Departments of Nutrition and Epidemiology, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT00006409
• Other Study ID Numbers: 934; U01HL066845
• First Posted: Oct 13, 2000
• Last Update Posted: Jul 22, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases

Study Results

Participant Flow

Arm/Group Title	6th-grade/2003 - Intervention	6th-grade/2003 - Control	8th-grade/2005 - Intervention	8th-grade/2005 - Control	8th-grade/2006 - Intervention	8th-grade/2006 - Control
Arm/Group Description	Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)	Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)	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)	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)	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)	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)
Period Title: Baseline
STARTED	865	856	0	0	0	0
COMPLETED	817	786	0	0	0	0
NOT COMPLETED	48	70	0	0	0	0
Period Title: Baseline
STARTED	0	0	1791	1713	0	0
COMPLETED	0	0	1540	1545	0	0
NOT COMPLETED	0	0	251	168	0	0
Period Title: Baseline
STARTED	0	0	0	0	1726	1776
COMPLETED	0	0	0	0	1664	1714
NOT COMPLETED	0	0	0	0	62	62

Baseline Characteristics

Arm/Group Title	6th-grade/2003 - Intervention	6th-grade/2003 - Control	8th-grade/2005 - Intervention	8th-grade/2005 - Control	8th-grade/2006 - Intervention	8th-grade/2006 - Control	Total
Arm/Group Description	Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)	Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)	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)	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)	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)	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)	Total of all reporting groups
Overall Participants	865	856	1791	1713	1726	1776	8727
Age (Count of Participants)
<=18 years	865 100%	856 100%	1791 100%	1713 100%	1726 100%	1776 100%	8727 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.94 (0.49)	11.98 (0.55)	14.00 (0.53)	13.99 (0.52)	13.97 (0.49)	13.99 (0.49)	11.96 (0.52)
Sex: Female, Male (Count of Participants)
Female	865 100%	856 100%	1791 100%	1713 100%	1726 100%	1776 100%	8727 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	6th-grade/2003 - Intervention	6th-grade/2003 - Control	8th-grade/2005 - Intervention	8th-grade/2005 - Control	8th-grade/2006 - Intervention	8th-grade/2006 - Control
Arm/Group Description	Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)	Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)	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)	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)	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)	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)
Measure Participants	0	0	1540	1545	0	0
Mean (Standard Error) [Minutes of MET-weighted MVPA˙]	136.5 (5.16)	136.9 (5.16)

2. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	6th-grade/2003 - Intervention	6th-grade/2003 - Control	8th-grade/2005 - Intervention	8th-grade/2005 - Control	8th-grade/2006 - Intervention	8th-grade/2006 - Control
Arm/Group Description	Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)	Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)	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)	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)	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)	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)
Measure Participants	0	0	0	0	1664	1714
Mean (Standard Error) [Minutes of MET-weighted MVPA˙]	136.4 (7.31)	125.5 (7.31)

Adverse Events

Arm/Group Title	6th-grade/2003 - Intervention		6th-grade/2003 - Control		8th-grade/2005 - Intervention		8th-grade/2005 - Control		8th-grade/2006 - Intervention		8th-grade/2006 - Control
Arm/Group Description	Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)		Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)		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)		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)		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)		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)
All Cause Mortality
	6th-grade/2003 - Intervention		6th-grade/2003 - Control		8th-grade/2005 - Intervention		8th-grade/2005 - Control		8th-grade/2006 - Intervention		8th-grade/2006 - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	6th-grade/2003 - Intervention		6th-grade/2003 - Control		8th-grade/2005 - Intervention		8th-grade/2005 - Control		8th-grade/2006 - Intervention		8th-grade/2006 - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/865 (0%)		0/856 (0%)		0/1791 (0%)		0/1713 (0%)		0/1726 (0%)		0/1776 (0%)
Other (Not Including Serious) Adverse Events
	6th-grade/2003 - Intervention		6th-grade/2003 - Control		8th-grade/2005 - Intervention		8th-grade/2005 - Control		8th-grade/2006 - Intervention		8th-grade/2006 - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/865 (0%)		0/856 (0%)		0/1791 (0%)		0/1713 (0%)		0/1726 (0%)		0/1776 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.