Trial of Activity for Adolescent Girls (TAAG)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
June Stevens, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00006409
First received: October 12, 2000
Last updated: June 29, 2015
Last verified: June 2015
Results First Received: February 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
Intervention: Behavioral: Trial of Activity for Adolescent Girls (TAAG)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
6th-grade/2003 - Intervention Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
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)
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)
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)
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)
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)

Participant Flow for 3 periods

Period 1:   Baseline
    6th-grade/2003 - Intervention     6th-grade/2003 - Control     8th-grade/2005 - Intervention     8th-grade/2005 - Control     8th-grade/2006 - Intervention     8th-grade/2006 - Control  
STARTED     865     856     0     0     0     0  
COMPLETED     817     786     0     0     0     0  
NOT COMPLETED     48     70     0     0     0     0  
Protocol Violation                 48                 70                 0                 0                 0                 0  

Period 2:   Post-2 Year Intervention
    6th-grade/2003 - Intervention     6th-grade/2003 - Control     8th-grade/2005 - Intervention     8th-grade/2005 - Control     8th-grade/2006 - Intervention     8th-grade/2006 - Control  
STARTED     0 [1]   0 [1]   1791 [2]   1713 [2]   0     0  
COMPLETED     0     0     1540     1545     0     0  
NOT COMPLETED     0     0     251     168     0     0  
Protocol Violation                 0                 0                 251                 168                 0                 0  
[1] 6th grade/2003 sample was not followed over time
[2] Sample is independent of 6th-grade/2003 sample that was measured at baseline

Period 3:   Post-3 Year Intervention
    6th-grade/2003 - Intervention     6th-grade/2003 - Control     8th-grade/2005 - Intervention     8th-grade/2005 - Control     8th-grade/2006 - Intervention     8th-grade/2006 - Control  
STARTED     0     0     0 [1]   0 [1]   1726 [2]   1776 [2]
COMPLETED     0     0     0     0     1664     1714  
NOT COMPLETED     0     0     0     0     62     62  
Protocol Violation                 0                 0                 0                 0                 62                 62  
[1] 8th-grade/2005 sample was not followed over time
[2] Sample is independent of 8th-grade/2005 sample that was measured post-2 year intervention



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
6th-grade/2003 - Intervention Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
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)
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)
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)
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)
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)
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  865     856     1791     1713     1726     1776     8727  
Age  
[units: participants]
             
<=18 years     865     856     1791     1713     1726     1776     8727  
Between 18 and 65 years     0     0     0     0     0     0     0  
>=65 years     0     0     0     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  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)  
Gender  
[units: participants]
             
Female     865     856     1791     1713     1726     1776     8727  
Male     0     0     0     0     0     0     0  



  Outcome Measures
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1.  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 ]

2.  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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: June Stevens
Organization: University of North Carolina - Chapel Hill
phone: 919-966-7218
e-mail: june_stevens@unc.edu


Publications of Results:
Cohen, D., Ashwood, S., Scott, M., Overton, A., Evenson, K. R., Voorhees, C. C., Bedimo-Rung, A., McKenzie, T. Proximity to School and Physical Activity Among Middle School Girls: The Trial of Activity for Adolescent Girls Study. Journal of Physical Activity and Health. 2006; 3(S1): S129-S138.

Other Publications:
Publications automatically indexed to this study:

Responsible Party: June Stevens, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00006409     History of Changes
Other Study ID Numbers: 934, U01HL066845
Study First Received: October 12, 2000
Results First Received: February 17, 2010
Last Updated: June 29, 2015
Health Authority: United States: Federal Government