Young 2008.
Study characteristics | ||
Methods |
Trial name: Trial of Activity for Adolescent Girls (TAAG) Study design: cluster‐RCT Intervention duration: 2‐year study‐directed intervention (autumn 2003 to spring 2005). A third‐year intervention used school and community personnel to direct intervention activities. Length of follow‐up from baseline: 2 years. Differences in baseline characteristics: the study population was diverse with the largest percentage of African American girls in Louisiana and South Carolina and the largest percentage of Hispanic girls in California and Arizona. Differences between groups at baseline were not presented. Unit of allocation: schools Unit of analysis: classrooms and schools |
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Participants |
School type: middle schools Region: TAAG was conducted at 6 university‐based field sites representing diverse geographic locations and populations: Universities of Arizona, Maryland, Minnesota and South Carolina, San Diego State University and Tulane University. Demographic/socioeconomic characteristics: not reported Inclusion/exclusion criteria Inclusion ‐ Public middle schools (grades 6–8) were eligible if the majority of children enrolled lived in the community served by the school, so that the community component of the intervention would be relevant to them. Exclusion ‐ Schools were unwilling or unable to respond to and report medical emergencies during the trial ‐ Planned to close or merge within 3 years ‐ < 90 girls in the eighth grade ‐ Expected transience of > 38% in any given year or 35% over 2 years ‐ Did not offer PE each semester for all grades ‐ < 2 (year‐round schools) or 3 (semester‐based schools) PE classes per week ‐ Participation in pilot testing of the study materials. ‐ Student exclusions included unable to read or understand questions in English, been told not to participate in or avoid exercise for health reasons, or have an existing medical condition; parent unwilling or unable to give consent; girls unwilling to assessment measurement. Number of schools allocated: 36 Numbers by trial group n (controls baseline) = 18 n (controls follow‐up) = 18 n (interventions baseline) = 18 n (interventions follow‐up) = 18 Note: all 36 schools participated in the sixth‐grade measurements during spring 2003 and in the eighth‐grade measurements during spring 2005; however, only 34 schools participated in the eighth‐grade measurements during spring 2006. Recruitment Schools: 6 schools were recruited at each of the 6 field centres (36 schools in total). Of the 68 schools invited to participate, 41 agreed and the 36 most conveniently accessed from the university‐based research centres were selected. Students: in each of 36 schools (6 per field centre), 60 randomly selected sixth‐grade girls were invited at baseline to be measured with a goal of measuring ≥ 80% (48) of those girls. At the end of the 2‐year intervention (endpoint) and in the subsequent year (follow‐up), 120 randomly selected eighth‐grade girls per field centre will be invited to participate in the measurements. Recruitment rate Schools: of the 68 schools invited to participate, 41 agreed (60%) and the 36 most conveniently accessed from the university‐based research centres were selected. Students:during spring 2003, 60 girls per school were randomly chosen. 1721/2160 (79.7%) eligible girls consented and participated in the measurement. During spring 2005, 4123 girls were eligible for the student‐level measurements, and 3504 (85.0%) consented and participated in the measurements. During spring 2006, 3915 were eligible at the 6 study sites, and 3502 (89.5%) consented and participated in the measurements. The approximate doubling of the number of girls measured in each eighth‐grade survey compared to the sixth‐grade survey was purposeful and based on their determination that the smaller sixth‐grade sample would have little adverse effect on power. |
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Interventions |
Number of experimental conditions: 2 (1 intervention, 1 control) Policies, practices or programmes targeted by the intervention Adaptation of PE classes to meet TAAG objectives and implementation of health education lessons were assessed through structured observations throughout the academic year by TAAG staff and teacher surveys at the end of the school year (dose, fidelity and acceptability). Implementation strategies EPOC: education meetings ‐ Health education, PE, science or homeroom teachers attended workshops to teach a series of 6 lessons that promoted development of behavioural skills associated with PA. Each health education lesson included an activity challenge (i.e. homework) in which students monitored a behaviour and set goals to increase their activity. EPOC: education materials ‐ PE teachers received instructional materials for PE lessons; social marketing efforts that included posters, flyers and special activities were launched to encourage overall PA and promote TAAG‐specific programmes to students. EPOC: educational outreach visits ‐ PE teachers received regular on‐site support to conduct lessons that encouraged active participation of girls during PE classes and to promote out‐of‐class PA. EPOC: interprofessional education ‐ Collaborations were created between schools, community agencies and TAAG university staff to increase girl‐focused PA programmes outside of PE classes. EPOC: local opinion leaders ‐ Programme champions were recruited and trained during the second intervention year, and they directed the intervention to enhance its sustainability in the third year. EPOC: local consensus processes ‐ Intervention goals were identified to indicate optimal intervention implementation. Goals varied by component, but essentially were set for 100% fidelity for delivery of the intervention by TAAG staff to teachers and 80% fidelity for delivery by teachers to the students. Theoretical underpinning: social‐ecological model, Operant Learning Theory, Social Cognitive Theory, organisational change and diffusions of innovation. Description of control: not reported but assume usual practice. |
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Outcomes |
Outcome relating to the implementation of school policies, practices or programmes Continuous ‐ Average number of PA programmes Dichotomous ‐ Students were encouraged for out‐of‐PE‐class PA (percentage of classes) ‐ Teacher used strategies to minimise management time (% classes) ‐ Students were provided with choices (percentage of classes) ‐ Students were encouraged for in‐class PA (% classes) ‐ Student equipment ratio was appropriate for activity (% classes) ‐ Group sizes were appropriate for activity (percentage of classes) ‐ Percentage of school reporting collaborations Data collection method Implementation of TAAG PE Fidelity: measured by observation. Implementation variable was observed 'some', 'most' or 'all' of class. Intervention goal = observation of 50% for item 1, 80% for all other items. Collaboration: interview with principal. Average number PE programmes: measured by surveys of PA programme leaders at intervention and control schools. Validity of measures used: trial used a combination of objective and self‐report components to assess implementation outcome. The self‐report components were reported as validated. Outcome relating to cost: not reported Outcome relating to adverse consequences: not reported Outcome relating to child diet, PA or weight status: PA and body composition Data collection method PA:assessed by accelerometer (daily MET weighted minutes of MVPA). Sedentary minutes were defined as the number of minutes with less than light activity. Anthropometry: BMI, height, weight and percentage body fat. Standing height was measured without shoes using a portable stadiometer (Shorr Productions) to the nearest 0.1 cm. Bodyweight was assessed using a digital scale (Seca 880) and measured to the nearest 0.1 kg while the girl was dressed in light clothing without shoes. Triceps skinfold thickness was measured in triplicate on the right side of the body to the nearest 0.1 mm. BMI was calculated as kg divided by height in metres squared. Percentage body fat was estimated from anthropometric measures using an equation that was developed for use in girls in this age range. Validity of measures used PA:not reported Anthropometry:valid |
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Notes |
Research funding: National Heart, Lung and Blood Institute; National Institutes of Health (U01HL66858, U01HL66857, U01HL66845, U01HL66856, U01HL66855, U01HL66853 and U01HL66852). Conflicts of interest: authors reported no conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation was stratified by field centre and by school district. Random sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | No information provided about allocation concealment and, therefore, it was unclear if allocation was concealed. |
Blinding of participants and personnel (performance bias) Implementation outcome | High risk | Outcome group: there was no mention that participants or personnel were blinded to experimental group and, therefore, were at high risk of performance bias. Outcome: child PA Low: objectively measured |
Blinding of outcome assessment (detection bias) Implementation outcome | High risk | Outcome group: not reported that observers or participants were blind to group allocation. Outcome group: BMI and child PA (objective data) Low: blinding would not impact objective measure. |
Incomplete outcome data (attrition bias) Implementation outcome | Low risk | Outcome group: low school attrition rate reported. All 36 schools participated in the measurements in 2003 and 2005 and 34 schools participated in 2006. No mention of ITT analysis in manuscripts. |
Selective reporting (reporting bias) | Low risk | There were no unreported implementation outcomes according to those planned in the published protocol. |
Other bias | Low risk | Did not appear to be at risk of contamination or other biases. |
Recruitment to cluster | Low risk | Individuals within each randomised cluster participated. |
Baseline imbalance | Low risk | Schools were randomly allocated to condition and so risk of baseline imbalance was low. |
Loss of cluster | Low risk | 2/36 schools in Louisiana were closed due to damage from Hurricane Katrina. There was no mention though to which condition these were assigned. |
Incorrect analysis | Low risk | All analyses took into account the expected positive intraclass correlation among responses for students, teachers and classes in the same school and school‐ or community‐level responses within the same site. |
Compatibility with individually randomised RCTs | Unclear risk | Unable to determine if a herd effect existed. |
Overall risk of bias assessment | Low risk | Most domains were at low risk of bias. |
3DPAR: 3‐Day Physical Activity Recall; AB: activity break; ANOVA: analysis of variance; BMI: body mass index; BSTS: Bihar School Teachers Study; CATCH: Child and Adolescent Trial for Cardiovascular Health; CDC: Centers for Disease Control and Prevention; df: degrees of freedom; DPA: daily physical activity; EPOC: Effective Practice and Organisation of Care; FARMS: free and reduced‐price meal; FRL: free/reduced price lunch; HNE: Hunter New England; HSAT: Healthy Schools Action Team; ITT: intention to treat; LEAP: Lifestyle Education for Activity Program; MET: Metabolic Equivalents of Task; MI: movement integration; MVPA: moderate to vigorous physical activity; n: number; NSLP: National School Lunch Program; NSW: New South Wales; PA; physical activity; PACE: Pilot of the Physically Active Children in Education; PAQ‐C: Physical Activity Questionnaire for Older Children; PE: physical education; PU30: Power Up for 30; RCT: randomised controlled trial; SAAFE: Supportive, Autonomous, Active, Fair, Enjoyable; SBP: School Breakfast Program; SCORES: Supporting Children's Outcomes using Rewards, Exercise and Skills; SEPS: School Environment and Policy Survey; SES: socioeconomic status; SHCP: Shaping Healthy Choices Program; SMART: Skills Management and Resistance Training; SNAK: School Nutrition Advances Kids; SOFIT: System for Observing Fitness Instruction Time; SOPLAY: System for Observing Play and Leisure Activity in Youth; SPARK: Sports, Play, and Active Recreation for Kids; TA: technical assistance; TAAG: Trial of Activity for Adolescent Girls; TACOS: Trying Alternative Cafeteria Options in Schools; TEENS: Teens Eating for Energy and Nutrition at School; TFS: Tobacco‐Free Society; TFT: Tobacco‐Free Teachers; WCC: Wellness Champions for Change.