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| 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
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 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) |
| 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 |
| 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 |
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| [2] | Sample is independent of 6th-grade/2003 sample that was measured at 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 | 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
| 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) |
| 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] |
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| <=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 |
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Gender
[units: participants] |
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| Female | 865 | 856 | 1791 | 1713 | 1726 | 1776 | 8727 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Outcome Measures
| 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 ] |
More Information
| 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. |
| 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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| Responsible Party: | June Stevens, Principal Investigator, University of North Carolina at 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: | April 26, 2010 |
| Health Authority: | United States: Federal Government |