Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries

Celis-Morales, C., Livingstone, K. M., Marsaux, C. F., Forster, H., O'Donovan, C. B., Woolhead, C., Macready, A. ORCID: https://orcid.org/0000-0003-0368-9336, Fallaize, R., Navas-Carretero, S., San-Cristobal, R., Kolossa, S., Hartwig, K., Tsirigoti, L., Lambrinou, C. P., Moschonis, G., Godlewska, M., Surwiłło, A., Grimaldi, K., Bouwman, J., Daly, E. J., Akujobi, V., O'Riordan, R., Hoonhout, J., Claassen, A., Hoeller, U., Gundersen, T. E., Kaland, S. E., Matthews, J. N., Manios, Y., Traczyk, I., Drevon, C. A., Gibney, E. R., Brennan, L., Walsh, M. C., Lovegrove, J. ORCID: https://orcid.org/0000-0001-7633-9455, Alfredo Martinez, J., Saris, W. H., Daniel, H., Gibney, M. and Mathers, J. C. (2015) Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries. Genes & Nutrition, 10 (1). 450. ISSN 1865-3499 doi: 10.1007/s12263-014-0450-2

Abstract/Summary

Improving lifestyle behaviours has considerable potential for reducing the global burden of non-communicable diseases, promoting better health across the life-course and increasing well-being. However, realising this potential will require the development, testing and implementation of much more effective behaviour change interventions than are used conventionally. Therefore, the aim of this study was to conduct a multi-centre, web-based, proof-of-principle study of personalised nutrition (PN) to determine whether providing more personalised dietary advice leads to greater improvements in eating patterns and health outcomes compared to conventional population-based advice. A total of 5,562 volunteers were screened across seven European countries; the first 1,607 participants who fulfilled the inclusion criteria were recruited into the trial. Participants were randomly assigned to one of the following intervention groups for a 6-month period: Level 0-control group-receiving conventional, non-PN advice; Level 1-receiving PN advice based on dietary intake data alone; Level 2-receiving PN advice based on dietary intake and phenotypic data; and Level 3-receiving PN advice based on dietary intake, phenotypic and genotypic data. A total of 1,607 participants had a mean age of 39.8 years (ranging from 18 to 79 years). Of these participants, 60.9 % were women and 96.7 % were from white-European background. The mean BMI for all randomised participants was 25.5 kg m(-2), and 44.8 % of the participants had a BMI ≥ 25.0 kg m(-2). Food4Me is the first large multi-centre RCT of web-based PN. The main outcomes from the Food4Me study will be submitted for publication during 2015.