Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000854235
Ethics application status
Approved
Date submitted
15/06/2009
Date registered
1/10/2009
Date last updated
24/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a school breakfast programme on school attendance and nutrition
Scientific title
Effect of a Breakfast in Schools Intervention in Low Decile Primary Schools on Attendance, Learning, Behaviour, Nutrition, and Food Security: a Stepped Wedge Cluster Randomised Controlled Trial
Secondary ID [1] 252692 0
09/084
Universal Trial Number (UTN)
09/084
Trial acronym
BISkIT (Breakfast In Schools Intervention Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of school breakfast intervention on attendance, learning, behaviour, nutrition, and food security 236999 0
Condition category
Condition code
Other 237334 237334 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Diet and Nutrition 237335 237335 0 0
Other diet and nutrition disorders
Public Health 237336 237336 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be the provision of a free breakfast at primary schools in deprived areas in the North Island, New Zealand. This will be delivered as either the Red Cross Breakfast in Schools Programme or a non-branded five day a week breakfast food provision programme. At a minimum, the breakfast provides weetbix and milk. There is no minimum or maximum amount of food allowed to be taken. The breakfast is provided in a suitable communal area prior to school starting, and is available for any child to attend of their own volition. It will be available every school day from the randomised start time over one school year. Participants will be followed up four times over the school year.
Intervention code [1] 236756 0
Lifestyle
Comparator / control treatment
The trial will be a stepped-wedge cluster randomised trial, where there is a one-way crossover of schools from control to intervention group at randomised periods. The control group consists of students in schools who have not yet crossed over to start receiving the breakfast in schools intervention. Control schools will start receiving the breakfast intervention at the randomised timepoint when they cross over from control to intervention. There are four cross over timepoints spread over the school year.
Control group
Active

Outcomes
Primary outcome [1] 238156 0
proportion of students with a school attendance rate of 95% or higher, measured using attendance data routinely collected by schools
Timepoint [1] 238156 0
Measured once every school term (four times) over one school year
Secondary outcome [1] 242395 0
Psychosocial function measured using Strengths and Difficulties Questionnaire
Timepoint [1] 242395 0
Measured once every school term (four times) over one school year
Secondary outcome [2] 242396 0
Academic achievement in literacy and numeracy will be assessed using an existing measure collected by schools. As there are a variety of tests in use, this will be determined once schools are recruited.
Timepoint [2] 242396 0
Measured once every school term (four times) over one school year
Secondary outcome [3] 242397 0
Student self-reported grades in reading will be assessed using one question self-ranking students on a 5-point Likert scale against other students in their Year in New Zealand
Timepoint [3] 242397 0
Measured once every school term (four times) over one school year
Secondary outcome [4] 242398 0
Number of sick days will be obtained from data routinely recorded by schools
Timepoint [4] 242398 0
Measured once every school term (four times) over one school year
Secondary outcome [5] 242399 0
Dietary habits will be briefly assessed using a measure developed for the study. The questions are based on questions from the New Zealand Health Survey, New Zealand Children's Nutrition Survey, and Mission On Survey
Timepoint [5] 242399 0
Measured once every school term (four times) over one school year
Secondary outcome [6] 242400 0
Temporary hunger will be assessed using an analog scaling device for measuring fullness in children ("Freddy")
Timepoint [6] 242400 0
Measured once every school term (four times) over one school year
Secondary outcome [7] 242401 0
Detailed nutrition assessment will be conducted in a sub-group of children using a self-completed four-day food and drink record, with the main outcome being change in absolute daily energy intake
Timepoint [7] 242401 0
Assessed at baseline and two-months after commencing the breakfast programme
Secondary outcome [8] 265833 0
Sense of belonging using the OECD Programme for International Student Assessment (PISA) 2000 Student Engagement Questionniare
Timepoint [8] 265833 0
Measured once every school term (four times) over one school year
Secondary outcome [9] 265834 0
Food security assessed using the Community Childhood Hunger Identification Project (CCHIP) scale
Timepoint [9] 265834 0
Measured once every school term (four times) over one school year

Eligibility
Key inclusion criteria
Schools: Primary schools in low-decile areas in the North Island of New Zealand, who have agreed to particpate in a free school breakfast programme, but have not yet commenced it. Schools must be of sufficient size that they estimate at least 25 students would participate in the programme. Students: students who report being likely to participate in the breakfast programme will be recruited
Minimum age
5 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools: The school has an existing breakfast programme running
Students: Another family member is enrolled in the study; child has a diagnosed food allergy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A stepped-wedge cluster randomised trial, whereby the school will be randomised to the time of crossover (one-way) from control to intervention. Randomisation will occur through a central randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A stepped-wedge cluster randomised trial design, which is most similar to a cross-over trial. However, cross-over is only one way (from control to intervention). Schools cross-over at one of four time points during the study (total 14 schools), and comparison is made between schools who are receiving the intervention and those who are still in the control group. All schools will be receiving the breakfast programme by the end of the study, but their randomised start time has been staggered over the year. At first, only four schools are receiving the breakfast programme while the remainder are control schools. At the next crossover, 7 schools will be receiving the breakfast programme, and 7 will be control schools. At the next crossover, 10 schools will receive the breakfast programme and 4 schools will continue being controls. Finally, all 14 schools will be receiving the breakfast programme.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 1834 0
New Zealand
State/province [1] 1834 0
North Island

Funding & Sponsors
Funding source category [1] 237151 0
Government body
Name [1] 237151 0
Health Research Council of New Zealand
Country [1] 237151 0
New Zealand
Primary sponsor type
University
Name
Clinical Trials Research Unit
Address
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 237006 0
None
Name [1] 237006 0
Address [1] 237006 0
Country [1] 237006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239245 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 239245 0
Ethics committee country [1] 239245 0
New Zealand
Date submitted for ethics approval [1] 239245 0
04/09/2009
Approval date [1] 239245 0
30/10/2009
Ethics approval number [1] 239245 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29742 0
Address 29742 0
Country 29742 0
Phone 29742 0
Fax 29742 0
Email 29742 0
Contact person for public queries
Name 12989 0
Assoc Prof Cliona Ni Mhurchu
Address 12989 0
Clinical Trials Research Unit
Level 4
School of Population Health
Tamaki Campus
University of Auckland
261 Morrin Road
Auckland
Country 12989 0
New Zealand
Phone 12989 0
+64 9 373 7599 ext 84494
Fax 12989 0
+64 9 373 1710
Email 12989 0
[email protected]
Contact person for scientific queries
Name 3917 0
Assoc Prof Cliona Ni Mhurchu
Address 3917 0
Clinical Trials Research Unit
Level 4
School of Population Health
Tamaki Campus
University of Auckland
261 Morrin Road
Auckland
Country 3917 0
New Zealand
Phone 3917 0
+64 9 373 7599 ext 84494
Fax 3917 0
+64 9 373 1710
Email 3917 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial.2010
N.B. These documents automatically identified may not have been verified by the study sponsor.