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

Study Protocol

Rupert A. Payne¹  Joanne Lucas²  Stuart Mackintosh²  Adam S. Butterworth³  Matthew Walker³  Zoe Tolkien³  Emanuele Di Angelantonio³  John Danesh³  Carmel Moore³  Stephen J. Sharp⁴  Barbora Silarova⁴  Guy Shefer⁴  Simon Griffin⁵  Christine Girling⁶  Kathryn Lawrence⁶  Juliet Usher-Smith⁷ 

[1] Cambridge Centre for Health Services Research, University of Cambridge, Institute of Public Health, Forvie Site, Robinson Way, CB2 0SR, Cambridge, UK;Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort’s Causeway, CB1 8RN, Cambridge, UK;Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort’s Causeway, CB1 8RN, Cambridge, UK;The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort’s Causeway, CB1 8RN, Cambridge, UK;MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, CB2 0QQ, Cambridge, UK;MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, CB2 0QQ, Cambridge, UK;The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, 2 Wort’s Causeway, CB1 8RN, Cambridge, UK;Patient and Public Involvement representatives, Cambridge, UK;The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, 2 Wort’s Causeway, CB1 8RN, Cambridge, UK;

关键词: Behaviour;    Cardiovascular diseases;    Communication;    Genetic;    Phenotypic;    Physical activity;    Protocol;    Randomised controlled trial;    Risk;   

DOI  :  10.1186/s12889-015-2192-5

 received in 2015-07-29, accepted in 2015-08-26,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundCardiovascular 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/DesignIn 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.DiscussionThe 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.Trial registrationCurrent Controlled Trials ISRCTN17721237. Registered 12 January 2015.

【 授权许可】

CC BY   
© Silarova et al. 2015