Trial Outcomes & Findings for Trial of Activity for Adolescent Girls (TAAG) (NCT NCT00006409)

NCT ID: NCT00006409

Last Updated: 2015-07-22

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8727 participants

Primary outcome timeframe

Post-2 year intervention

Results posted on

2015-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Baseline STARTED	865	856	0	0	0	0
Baseline COMPLETED	817	786	0	0	0	0
Baseline NOT COMPLETED	48	70	0	0	0	0
Post-2 Year Intervention STARTED	0	0	1791	1713	0	0
Post-2 Year Intervention COMPLETED	0	0	1540	1545	0	0
Post-2 Year Intervention NOT COMPLETED	0	0	251	168	0	0
Post-3 Year Intervention STARTED	0	0	0	0	1726	1776
Post-3 Year Intervention COMPLETED	0	0	0	0	1664	1714
Post-3 Year Intervention NOT COMPLETED	0	0	0	0	62	62

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Baseline Protocol Violation	48	70	0	0	0	0
Post-2 Year Intervention Protocol Violation	0	0	251	168	0	0
Post-3 Year Intervention Protocol Violation	0	0	0	0	62	62

Baseline Characteristics

Trial of Activity for Adolescent Girls (TAAG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	6th-grade/2003 - Intervention n=865 Participants Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)	6th-grade/2003 - Control n=856 Participants 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 n=1791 Participants 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 n=1713 Participants 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 n=1726 Participants 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 n=1776 Participants 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 n=8727 Participants Total of all reporting groups
Age, Categorical <=18 years	865 Participants n=5 Participants	856 Participants n=7 Participants	1791 Participants n=5 Participants	1713 Participants n=4 Participants	1726 Participants n=21 Participants	1776 Participants n=8 Participants	8727 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	11.94 years STANDARD_DEVIATION 0.49 • n=5 Participants	11.98 years STANDARD_DEVIATION 0.55 • n=7 Participants	14.00 years STANDARD_DEVIATION 0.53 • n=5 Participants	13.99 years STANDARD_DEVIATION 0.52 • n=4 Participants	13.97 years STANDARD_DEVIATION 0.49 • n=21 Participants	13.99 years STANDARD_DEVIATION 0.49 • n=8 Participants	11.96 years STANDARD_DEVIATION 0.52 • n=8 Participants
Sex: Female, Male Female	865 Participants n=5 Participants	856 Participants n=7 Participants	1791 Participants n=5 Participants	1713 Participants n=4 Participants	1726 Participants n=21 Participants	1776 Participants n=8 Participants	8727 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Post-2 year intervention

Outcome measures

Outcome measures
Measure	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 n=1540 Participants 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 n=1545 Participants 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)
MET-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	136.9 Minutes of MET-weighted MVPA˙ Standard Error 5.16	—	—

PRIMARY outcome

Timeframe: Post-3 year intervention