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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.

Silarova B, Lucas J, Butterworth AS, Di Angelantonio E, Girling C, Lawrence K, Mackintosh S, Moore C, Payne RA, Sharp SJ, Shefer G, Tolkien Z, Usher-Smith J, Walker M, Danesh J, Griffin S - BMC Public Health (2015)

Bottom Line: 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.The experiences, attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups.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.

View Article: PubMed Central - PubMed

Affiliation: MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. Barbora.Silarova@mrc-epid.cam.ac.uk.

ABSTRACT

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.

Trial registration: Current Controlled Trials ISRCTN17721237 . Registered 12 January 2015.

No MeSH data available.


Related in: MedlinePlus

INFORM Trial CONSORT Diagram
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Fig1: INFORM Trial CONSORT Diagram

Mentions: The design of the trial and flow of participants are shown in Fig. 1. 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. Lifestyle advice consists of three sessions of interactive, tailored web-based information. The qualitative element of the study consists of individual interviews and focus groups with trial participants at different time points throughout the trial.Fig. 1


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.

Silarova B, Lucas J, Butterworth AS, Di Angelantonio E, Girling C, Lawrence K, Mackintosh S, Moore C, Payne RA, Sharp SJ, Shefer G, Tolkien Z, Usher-Smith J, Walker M, Danesh J, Griffin S - BMC Public Health (2015)

INFORM Trial CONSORT Diagram
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4562192&req=5

Fig1: INFORM Trial CONSORT Diagram
Mentions: The design of the trial and flow of participants are shown in Fig. 1. 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. Lifestyle advice consists of three sessions of interactive, tailored web-based information. The qualitative element of the study consists of individual interviews and focus groups with trial participants at different time points throughout the trial.Fig. 1

Bottom Line: 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.The experiences, attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups.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.

View Article: PubMed Central - PubMed

Affiliation: MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. Barbora.Silarova@mrc-epid.cam.ac.uk.

ABSTRACT

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.

Trial registration: Current Controlled Trials ISRCTN17721237 . Registered 12 January 2015.

No MeSH data available.


Related in: MedlinePlus