Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour
Di, Angelantonio Emanuele
BMC Public Health
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Silarova, B., Lucas, J., Butterworth, A., Di, A. E., Girling, C., Lawrence, K., Mackintosh, S., et al. (2015). Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour. BMC Public Health, 15 (868)https://doi.org/10.1186/s12889-015-2192-5
Background: Cardiovascular disease (CVD) remains the leading cause of death globally. Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions. An integral part of this approach is the use of CVD risk scores. Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies. We aim to evaluate short-term effects of providing different types of information about coronary heart disease (CHD) risk, alongside lifestyle advice, on health-related behaviours. Methods/Design: In a parallel-group, open randomised trial, we are allocating 932 male and female blood donors with no previous history of CVD aged 40¬–84 years in England to either no intervention (control group) or to one of three active intervention groups: i) lifestyle advice only; ii) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics; and iii) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics. The primary outcome is change in objectively measured physical activity. Secondary outcomes include: objectively measured dietary behaviours; cardiovascular risk factors; current medication and healthcare usage; perceived risk; cognitive evaluation of provision of CHD risk scores; and psychological outcomes. The follow-up assessment takes place 12 weeks after randomisation. The experiences, attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups. Discussion: The INFORM study has been designed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours.
Behaviour, Cardiovascular diseases, Communication, Genetic, Phenotypic, Physical activity, Protocol, Randomised controlled trial, Risk
INFORM is funded by European Commission Framework 7 EPIC-CVD Grant agreement no: 279233. NHS Blood and Transplant funded the INTERVAL trial. DNA extraction and genotyping in INTERVAL/INFORM was funded by the UK National Institute of Health Research. The coordinating team for INTERVAL/INFORM at the Cardiovascular Epidemiology Unit of the University of Cambridge was supported by core funding from: UK Medical Research Council (G0800270), British Heart Foundation (SP/09/002), British Heart Foundation Cambridge Cardiovascular Centre of Excellence, and UK National Institute for Health Research Cambridge Biomedical Research Centre.
European Commission (279233)
Medical Research Council (MC_U106179474)
British Heart Foundation (RG/08/014/24067)
External DOI: https://doi.org/10.1186/s12889-015-2192-5
This record's URL: https://www.repository.cam.ac.uk/handle/1810/250395
Creative Commons Attribution 4.0
Licence URL: http://creativecommons.org/licenses/by/4.0/