Karpouzis, F.
Lindberg, R.
Walsh, A.
Shah, S.
Abbott, G.
Ball, K.
Funding for this research was provided by:
National Health and Medical Research Council (APP1191162)
Article History
Received: 11 July 2023
Accepted: 12 February 2024
First Online: 1 March 2024
Declarations
:
: This study was approved by the Human Ethics Advisory Group, Faculty of Health at Deakin University (HEAG-H-31_2020), as well the Department of Education, via the NSW State Education Research Application Process (SERAP 2019163). This trial was prospectively registered with the Australian and New Zealand Clinical Trials Registry [ACTRN12620001347954] on 14/12/2023. All methods were carried out in accordance with relevant guidelines and regulations of <i>The Declaration of Helsinki</i>.Prior to trial commencement, plain language statements were issued to participants outlining study protocol, potential benefits and risks, including options for withdrawal from the trial. Written informed consent was obtained from school principals and teachers. Opt-out consent was issued to parents/carers and to their children. Children were also given the choice to opt out in class if they did not want to participate in this trial during survey collection. Children’s participation in the FEAST program with their peers continued, regardless of their participation in this trial. Informed opt-out consent was obtained from all the children’s parents/carers. Only one parent/guardian withdrew consent via the opt-out process.
: Not applicable.
: The authors declare no competing interests.