Ni Mhurchu et al. BMC Public Health 2010, 10:738 http://www.biomedcentral.com/1471-2458/10/738 Data on all individual study participants are collected once each school term over the entire school year. Aims The primary aim is to investigate the effects of a school breakfast programme in low decile schools on students’ attendance. Secondary aims include examination of the impact of the school breakfast programme on students’ school achievement, psychosocial function and nutrition. Study sample Eligible schools are decile 1-4 primary schools (students aged 5-13 years) located in selected regions (Auckland, Northland, Waikato, Wellington) in the North Island of New Zealand. To take part in the study, schools must not have an existing breakfast programme and must agree to start one in the 2010 school year. Schools must be of sufficient size that they estimate at least 25 stu- dents would attend the breakfast programme each day. Eligible participants are students aged 5-13 years who plan to attend the school breakfast club at least occasion- ally and do not have a diagnosed food allergy. Only one child per household may take part. Recruitment involves researchers and/or the school principal briefly outlining the study during a regular school assembly or classroom talks and answering any questions children have. Those interested in taking part in the study are asked to register their interest and take a study information pack home to their parents/caregivers. The study pack includes partici- pant information, a consent form for parents, an assent form for children, forms to collect demographic informa- tion (e.g., age, sex and ethnicity of the child, household income) and parents’ contact details, and an envelope in which to return completed forms. Students return com- pleted forms to their teacher or the school office, and these are collected by researchers. Sample size calculations The target sample size is a total of 16 schools (four schools per sequence) with an average 25 students per school, i.e. a total of 400. Assuming an intra-cluster coefficient (ICC) of 0.05, this sample size will provide at least 85% power, with a significance level of a = 0.05, to detect a 10% absolute increase in the proportion of stu- dents with a school attendance rate of 95% or higher. Ethics approval Ethical approval for the trial was received from the Northern Y Regional Ethics Committee (Reference: NTY/09/09/084). Randomisation and blinding Schools are randomly allocated to one of the four sequences for time of crossover from control to Page 3 of 6 intervention phase using a computer-generated list of random numbers. The allocation sequence is overseen by the study statistician (YJ). Consideration is given to school decile and school type in order to reduce the potential imbalance between sequences. Due to the nat- ure of the study intervention it is not possible to blind participants, breakfast providers, or outcome assessors. However, choice of an objective primary outcome (school attendance using routinely collected data from schools) should minimise risk of bias. Intervention The intervention is a free daily before-school breakfast programme; either the Red Cross Breakfast in Schools programme or an unbranded school breakfast pro- gramme provided by Fonterra and Sanitarium. The Red Cross Breakfast in Schools programme is available to decile 1 primary schools. Food is provided free of charge by Countdown supermarkets (Progressive Enterprises Ltd). Schools select from a list of foods that includes breakfast cereal (wheat biscuits), milk, bread, spreads (margarine, jam, honey, Marmite), Milo (choco- late flavoured drink powder), milk powder and sugar. Food is delivered weekly. During the trial the programme is set up and run as usual through the Red Cross, with schools responsible for finding volunteers to run the pro- gramme and Red Cross providing assistance and training. The unbranded school breakfast programme is available to decile 1-4 primary and intermediate schools. Food is provided by Fonterra Co-operative Group Limited (fresh or UHT milk) and Sanitarium Health Food Company (Weet-Bix). Milk is provided weekly (where fresh milk is supplied) and Weet-Bix and UHT milk delivered each term. During the trial the programme is set up and run as usual, with schools providing volunteers to run the breakfast programme. Schools are provided with information on how to set up and run a breakfast club, but are responsible for finding a suitable venue, equipment and volunteers to run the breakfast club. Schools are offered NZ$1000 as reimbursement for their participation in the trial, and this may be used to help set up the breakfast club or for other purposes. No attempts are made to standardise the intervention or its delivery in individual schools. Study outcome measures Assessments (Table 1) are undertaken before school starts to minimise disruption to students’ schooling. For schools that have started the intervention, assessments take place at the breakfast club venue after students have eaten breakfast and before they start school. In control schools assessments take place at a suitable venue, such as a hall or classroom. Students complete questionnaires independently where possible. Questions