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Article History

Received: 19 May 2020

Accepted: 22 September 2020

First Online: 15 October 2020

Ethics approval and consent to participate

: Full ethical approval was granted on 21 July 2019 from the University of Southampton’s Faculty of Medicine Ethics Committee (Ethics ID 49226). Once the school has agreed to participate, the head teacher has signed the consent form, and the randomisation process is complete, the appropriate trial documents for parents and students are provided for the schools to disseminate. Two versions of the letter for parents and the participant information sheets have been produced: one for intervention schools and one for control schools. In both cases, parents and students are provided with contact details of the research team in case they have questions about taking part in the research trial. For both intervention and control schools, consent will be opt-in and collected by the schools prior to any research data being collected. In keeping with good practice, the consent form for intervention schools requires parents to initial boxes for each part of the intervention to ensure they understand and consent to each part separately. In all cases, student assent is also required and it is made clear that taking part is voluntary and a student or parent can withdraw their assent/consent at any time without giving a reason. The consent documents are collected by the study team at the baseline visit to schools and are thereafter stored securely at the MRC LEU.

: No details, images or videos relating to an individual person are included. Model consent forms will be provided on request.

: KG has received reimbursement for speaking at conferences sponsored by nutrition companies and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec and Danone. The University of Southampton has received an unrestricted donation from Danone Nutricia to support LifeLab’s work with schools. Wendy Lawrence has received funding from Danone Nutritia Early Life Nutrition for training and presentations. CC has received lecture fees and honoraria from Amgen, Danone, Eli Lilly, GSK, Kyowa Kirin, Medtronic, Merck, Nestlé, Novartis, Pfizer, Roche, Servier, Shire, Takeda and UCB outside of the submitted work. Outside of the submitted work, CV has a non-financial research relationship with a food retail company and maintains independence in all evaluation activities. This article, however, is not related to this relationship.All other authors STS, MB, KWT, SCS, DML, DL, LB, RA, TH, NK, JVS, PC, JC, LC, PL, JL, MG, DC, MH, DF, LM, JB, HMI and MEB have no competing interests to declare.