BACKGROUND: @entity65 ( @entity65 ) remains the leading cause of @entity204 globally. Primary prevention of @entity65 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 @entity65 risk scores. Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using @entity65 risk scores as part of preventive strategies. We aim to evaluate short-term effects of providing different types of information about @entity301 ( @entity301 ) 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 @entity65 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 @entity301 risk based on phenotypic characteristics; and iii) lifestyle advice plus information on estimated 10-year @entity301 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 @entity301 risk scores; and psychological outcomes. The follow-up assessment takes place 12 weeks after randomisation. The experiences, attitudes and concerns of a subset of @entity1 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 @entity301 risk and lifestyle advice on health-related behaviours. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17721237 . Registered 12 January 2015.

Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about XXXX risk, alongside lifestyle advice, to achieve change in health-related behaviour.

@entity1 :: ('9606', 'Species') :: ['participants'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity65 :: ('MESH:D002318', 'Disease') :: ['Cardiovascular disease', 'CVD'] @entity301 :: ('MESH:D003327', 'Disease') :: ['CHD', 'coronary heart disease']
@entity301 :: (MESH:D003327,Disease) :: ['coronary heart disease']
