Cardiovascular Diseases, Heart Diseases, Obesity
Conditions
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
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
Study design
Eligibility
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
| Measure | Time 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
| Arm | Count |
|---|---|
| 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 |
| Total | 8,727 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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
| Characteristic | 6th-grade/2003 - Control | 8th-grade/2005 - Intervention | 8th-grade/2005 - Control | 8th-grade/2006 - Intervention | 8th-grade/2006 - Control | 6th-grade/2003 - Intervention | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 856 Participants | 1791 Participants | 1713 Participants | 1726 Participants | 1776 Participants | 865 Participants | 8727 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.98 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 Participants | 1791 Participants | 1713 Participants | 1726 Participants | 1776 Participants | 865 Participants | 8727 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 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 / 865 | 0 / 856 | 0 / 1,791 | 0 / 1,713 | 0 / 1,726 | 0 / 1,776 |
| serious Total, serious adverse events | 0 / 865 | 0 / 856 | 0 / 1,791 | 0 / 1,713 | 0 / 1,726 | 0 / 1,776 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 8th-grade/2005 - Intervention | 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 |
| 8th-grade/2005 - Control | MET-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 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 8th-grade/2006 - Intervention | MET-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 - Control | MET-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 |