Rush 2012.

Study characteristics
Methods	Study name: Project Energize Study design: cluster‐RCT Intervention period: 2 years Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: schools Unit of analysis: individual accounting for clustering
Participants	N (control baseline) = NR N (control follow‐up) = 660 N (intervention baseline) = NR N (intervention follow‐up) = 692 Setting (and number by study group): 124 schools (62 intervention, 62 control) Recruitment: NR Geographic region: Waikato Region of New Zealand Percentage of eligible population enrolled: 50% participants Mean age: intervention + control: 5 years and 10 years Sex: intervention: 49% female; control: 50%‐51% female
Interventions	To compare changes in blood pressure and body composition in children who attended Energize schools with children in control schools. The trial also aimed to identify predictors of increase in body fat and blood pressure over 2 years in relation to age, sex, ethnicity, rurality and social deprivation. Children Each of the 11 team Energize staff (‘energizers’) was allocated between 6 and 8 schools each, by the team manager. Classes modelled included fundamental movement skill training, ideas for ‘huff and puff’ fitness activities, modified games, and ball activities and sport‐related games, where keeping children moving as much as possible throughout each session was the focus. Also, energizers promoted active transport, lunchtime games, bike days and leadership training for students to be leaders of PAs before and after school. Assist each school with a range of healthy‐eating initiatives. These included canteen makeovers. Healthy fund raising was promoted. Nutrition ‘nuggets’ were also provided every week in the school newsletter. A home–school link programme that provided opportunities for parents to attend 3 information‐based sessions, which included a 45‐min practical nutrition class. Teachers and local community: Project offered assistance to teachers, parents and the local community. This was implemented through a range of activities, such as professional development and evenings with a dietitian Each control school involved in the project worked with their energizer to develop an individualised action plan based on the individual needs of the school. Given no additional resourcing or information Diet and PA combination intervention vs control
Outcomes	Outcome measures Primary outcome: BMI, body fat, resting blood pressure (all SD scores) Secondary outcomes: NR Process evaluation: NR
Implementation‐related factors	Theoretical basis: NR Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: gender, SES, place (rural/urban) PROGRESS categories analysed at outcome: gender, race/ethnicity Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: reported (direct costs)
Notes	ACTRN12610000132044 Funding: the Waikato District Health Board funds the Project Energize programme and its evaluation. The Ministry of Health, New Zealand has contributed to evaluation funding. Implementation: while the evaluation measurements were undertaken 2 years from the commencement of the intervention, the nature of the intervention process meant that it was able to be implemented only in a graduated way, reflecting the characteristics and capacities of individual schools. This led to a shorter duration of intervention implementation before endpoint measurements for lower‐decile schools, where a higher proportion of Maori children attend. Sport Waikato was contracted by the Waikato District Health Board to deliver Project Energize. ‘Team Energize’ are either teachers or graduates in the fields of exercise and nutrition, or PE, employed by Sport Waikato to support the delivery and development of the programme in each intervention school. Following this RCT the intervention was rolled out as a region‐wide whole‐school nutrition and PA programme. Costs: the programme is cost‐effective, the main costs are the salaries of the Energizers and team leader and the travel required to move between schools. We calculate that the average cost of the intervention for each child, each year, is < NZD 40 and this could be improved by further efficiencies.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stratified by rurality and social deprivation and randomised, no further details
Allocation concealment (selection bias)	Unclear risk	NR
Blinding (performance bias and detection bias) All outcomes	Low risk	The measurement teams were trained in all measurements and blind to the allocation of the school at baseline and follow‐up.
Incomplete outcome data (attrition bias) All outcomes	High risk	20% of the younger children and 43% of the older children were lost to follow‐up; NR by group
Selective reporting (reporting bias)	Low risk	Protocol seen; all outcomes specified in methods were reported in results
Other bias	Low risk	No additional threats to validity
Other bias‐ timing of recruitment of clusters	Unclear risk	NR