Saunders 2006.

Study characteristics
Methods	Trial name: Lifestyle Education for Activity Program (LEAP) Study design: cluster‐RCT for implementation outcome Intervention duration: 2 years Length of follow‐up from baseline: 12 months Differences in baseline characteristics: there were no baseline age or racial/ethnic differences between girls in the control and the intervention schools. Unit of allocation: schools Unit of analysis: school
Participants	School type: high schools in 14 South Carolina counties (1998–2000) Region: South Carolina, US Demographic/socioeconomic characteristics: no details about participating schools. Of students, 48.7% were African American and 46.7% were white, which was comparable to the population of the participating schools. Inclusion/exclusion criteria: not reported Number of schools allocated: 24 Numbers by trial group n (controls baseline) = 12 schools and 1221 girls n (controls follow‐up) = 12 schools and 741 girls n (interventions baseline) = 12 schools and 1523 girls n (interventions follow‐up) = 12 schools and 863 girls Recruitment Schools: not reported Students: 8155 eighth‐grade girls who attended 1 of the 31 middle schools that "fed" students to the 24 participating high schools were invited to complete the measures. These girls participated in a school assembly during which the measurement protocol was explained, incentives were described (gifts and promotional items valued at < USD10), and all girls were invited to participate. Recruitment rate School districts:not reported Schools: 24 schools, did not report school recruitment rate. Students:97% of those recruited completed the baseline measures (2744/2841 eighth‐grade girls who volunteered to participate in the measurement protocol).
Interventions	Number of experimental conditions: 2 (1 intervention, 1 control) Policies, practices or programmes targeted by the intervention The LEAP intervention focused on changing personal, social and environmental factors related to PA and involved changes to the school environment and instructional programmes. Instructional programme components included changes in PE and health instruction to enhance PA self‐efficacy and enjoyment. Schools were not required to implement a specific LEAP curriculum. Rather, to change instructional practice. The environmental strategy involved changing school practices that encouraged and supported PA and included changes to school health services, faculty staff health promotion, school environment and school community linkages. The original 6 components of LEAP from the Coordinated School Health Program model were expanded to 16 "essential elements" (including instructional and environmental). Of these, schools were expected to implement all instructional elements and 3 environmental elements (school administrator support, school PA team and media messages promoting PA). Implementation strategies EPOC: educational outreach visits ‐ 2 full‐time programme support staff provided. EPOC: local opinion leaders ‐ Each LEAP team was headed by a LEAP champion who was usually the teacher responsible for girls PE. The LEAP champion was either the person assigned to be the primary contact for the school or the person who evolved as the strongest supporter of the intervention effort. The LEAP champion, in co‐ordination with the LEAP project staff, worked to involve school administrators, teachers and staff in the LEAP team. EPOC: educational meetings ‐ Schools received training and strong encouragement to implement the remaining environmental elements. Staff training consisted of formal workshops and 1‐on‐1 TA for school personnel. Training was provided through in‐service days before and during the school year. EPOC: educational materials ‐ LEAP staff maintained a wide range of resources, including PA videotapes and books EPOC: other ‐ Equipment (hand weights, exercise bands, pedometers) for the intervention schools. EPOC: local consensus processes ‐ LEAP staff worked with the LEAP champion and the LEAP team in each school to identify opportunities to enhance the environment or change school policy in support of PA. Training was provided for developing and implementing strategic plans to promote PA in the school. LEAP staff provided ongoing consultation and support to LEAP schools through regular visits, telephone calls, e‐mail and lists. Theoretical underpinning An ecological model provided the organising framework for the LEAP intervention and drew primarily from Social Cognitive Theory for the overall intervention. Nothing specific to the implementation strategy. Description of control: 12 control schools received no treatment.
Outcomes	Outcome relating to the implementation of school policies, practices or programmes ‐ (Active PA team) School PA team – a team that regularly planned, implemented and evaluated student and faculty PA programmes. ‐ (Admin support) School administrator supports PA promotion – tangible support from the principal for PA promotion, such as providing time and resources PE classes and PA programmes; participates on PA team. ‐ (Emphasise lifelong PE) Emphasises lifelong PA – classes emphasise a variety lifetime PAs girls enjoy, such as dance, aerobics, strength training, etc. ‐ (Co‐op options in PE) Included co‐operative activities – PE had co‐operative games, activities and team‐building, along with the traditional, competitive sport activities. ‐ (Provide health services) School nurse counselling for PA (health services) – school nurse regularly counselled students about PA and had materials related to PA in health room. ‐ (Health promotion for staff) Adult modelling of PA through faculty/staff health promotion – school had an active wellness programme in place which sponsors PA programmes for staff. ‐ (Provide health education) Health education reinforced messages and skills taught in PE – instructional activities in health education complemented and reinforced those taught in PE. ‐ (Co‐ordinate PA events with community) Community agency involvement – school collaborated with community agencies to provide PA programmes and resources for students, faculty/staff and families. ‐ (Family involvement) Family involvement – families were provided information about PA, PA resources and PA opportunities. Data collection method: the organisational assessment interview was a 22‐item interview (administered in 10–15 minutes) conducted by the independent process evaluator in all intervention and control schools with a school administrator (usually assistant principal), to assess organisational‐level components (i.e. school environment and instruction practice consistent with the LEAP intervention). This tool assessed organisational‐level factors and, unlike the process tools described in the previous section, was not designed to measure implementation. The organisational assessment rated 9 of the essential elements, including 7 environmental factors and 2 instructional factors. Additional items assessed events and activities (secular events) that could affect project outcomes such as participation in PE teacher training and receiving an award in school health, and organisational resources such as budget for PE. Validity of measures used: not reported/self‐report methods Outcome relating to cost: not reported Outcome relating to adverse consequences: not reported Outcome relating to child diet, PA or weight status: PA and weight status Data collection method PA:the 3DPAR, a modification of the Previous Day Physical Activity Recall, was used to assess PA. Weight status:height and weight were measured in a private setting while students were dressed in light clothing. Height was measured to the nearest 1.0 cm with a portable stadiometer (Shorr Productions, Olney, Maryland); weight was measured to the nearest 0.1 kg with a calibrated digital scale (model PS6600, BeFour, Inc, Saulsville, WI). BMI was calculated as bodyweight in kg divided by height in metres squared. Validity of measures used PA:3DPAR Weight status:BMI classified in accordance with the CDC's growth charts for BMI.
Notes	Notes: in the LEAP trial, implementation of targeted policies and practices in the experimental group was presented in subgroups of 'high' and 'low' implementers and could not be combined into a single group. As such, effect size estimates for outcomes reported in this trial between groups were unable to be reported. Research funding: National Heart, Lung and Blood Institute (R01 HL057775) Conflicts of interest: authors reported no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Schools were paired by school size, percentage of girls who were African American, urban/suburban or rural location and class structure. Schools from each pair were randomly assigned to control or intervention groups. Random sequence generation procedure 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: all Given the nature of the intervention, participants and study personnel are likely to have been aware of study allocation and, therefore, high risk of performance bias.
Blinding of outcome assessment (detection bias) Implementation outcome	High risk	Outcome group: organisational assessment interview. No blinding of outcome assessment and the outcome measurement was likely to be influenced by lack of blinding; self‐report considered high risk.
Incomplete outcome data (attrition bias) Implementation outcome	Low risk	Outcome group: organisational assessment interview. There were no missing outcome data and, therefore, low risk of attrition bias. Outcome: BMI and child PA High: loss to follow‐up 24% at 1 year; unclear if this was even across groups. Did not mention the use of ITT.
Selective reporting (reporting bias)	Unclear risk	No study protocol, therefore, it was unclear if there was selective outcome reporting.
Other bias	Low risk	Appeared free from other bias.
Overall risk of bias assessment	Unclear risk	Most domains were at low or unclear risk of bias.