Randomized Controlled Trial

. 2015 Sep 7:15:868.

doi: 10.1186/s12889-015-2192-5.

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

Barbora Silarova¹, Joanne Lucas², Adam S Butterworth^{3

4}, Emanuele Di Angelantonio^{5

6}, Christine Girling⁷, Kathryn Lawrence⁸, Stuart Mackintosh⁹, Carmel Moore^{10

11}, Rupert A Payne¹², Stephen J Sharp¹³, Guy Shefer¹⁴, Zoe Tolkien^{15

16}, Juliet Usher-Smith¹⁷, Matthew Walker^{18

19}, John Danesh^{20

21}, Simon Griffin^{22

23}

Affiliations

¹ MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. Barbora.Silarova@mrc-epid.cam.ac.uk.
² Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. jl294@medschl.cam.ac.uk.
³ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. asb38@medschl.cam.ac.uk.
⁴ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. asb38@medschl.cam.ac.uk.
⁵ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. ed303@medschl.cam.ac.uk.
⁶ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. ed303@medschl.cam.ac.uk.
⁷ Patient and Public Involvement representatives, Cambridge, UK. chrisgirling191086@gmail.com.
⁸ Patient and Public Involvement representatives, Cambridge, UK. kathryn.lawrence@ntlworld.com.
⁹ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. sm2123@medschl.cam.ac.uk.
¹⁰ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. csm47@medschl.cam.ac.uk.
¹¹ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. csm47@medschl.cam.ac.uk.
¹² Cambridge Centre for Health Services Research, University of Cambridge, Institute of Public Health, Forvie Site, Robinson Way, Cambridge, CB2 0SR, UK. rap55@medschl.cam.ac.uk.
¹³ MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. stephen.sharp@mrc-epid.cam.ac.uk.
¹⁴ MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. Guy.Shefer@mrc-epid.cam.ac.uk.
¹⁵ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. zajt2@medschl.cam.ac.uk.
¹⁶ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. zajt2@medschl.cam.ac.uk.
¹⁷ The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, 2 Wort's Causeway, Cambridge, CB1 8RN, UK. jau20@medschl.cam.ac.uk.
¹⁸ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. mrw40@medschl.cam.ac.uk.
¹⁹ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. mrw40@medschl.cam.ac.uk.
²⁰ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. john.danesh@phpc.cam.ac.uk.
²¹ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. john.danesh@phpc.cam.ac.uk.
²² MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. sjg49@medschl.cam.ac.uk.
²³ The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, 2 Wort's Causeway, Cambridge, CB1 8RN, UK. sjg49@medschl.cam.ac.uk.

PMID: 26345710
PMCID: PMC4562192
DOI: 10.1186/s12889-015-2192-5

Randomized Controlled Trial

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

Barbora Silarova et al. BMC Public Health. 2015.

. 2015 Sep 7:15:868.

doi: 10.1186/s12889-015-2192-5.

Authors

Affiliations

¹ MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. Barbora.Silarova@mrc-epid.cam.ac.uk.
² Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. jl294@medschl.cam.ac.uk.
³ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. asb38@medschl.cam.ac.uk.
⁴ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. asb38@medschl.cam.ac.uk.
⁵ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. ed303@medschl.cam.ac.uk.
⁶ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. ed303@medschl.cam.ac.uk.
⁷ Patient and Public Involvement representatives, Cambridge, UK. chrisgirling191086@gmail.com.
⁸ Patient and Public Involvement representatives, Cambridge, UK. kathryn.lawrence@ntlworld.com.
⁹ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. sm2123@medschl.cam.ac.uk.
¹⁰ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. csm47@medschl.cam.ac.uk.
¹¹ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. csm47@medschl.cam.ac.uk.
¹² Cambridge Centre for Health Services Research, University of Cambridge, Institute of Public Health, Forvie Site, Robinson Way, Cambridge, CB2 0SR, UK. rap55@medschl.cam.ac.uk.
¹³ MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. stephen.sharp@mrc-epid.cam.ac.uk.
¹⁴ MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. Guy.Shefer@mrc-epid.cam.ac.uk.
¹⁵ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. zajt2@medschl.cam.ac.uk.
¹⁶ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. zajt2@medschl.cam.ac.uk.
¹⁷ The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, 2 Wort's Causeway, Cambridge, CB1 8RN, UK. jau20@medschl.cam.ac.uk.
¹⁸ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. mrw40@medschl.cam.ac.uk.
¹⁹ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. mrw40@medschl.cam.ac.uk.
²⁰ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. john.danesh@phpc.cam.ac.uk.
²¹ The INTERVAL trial coordinating centre, Department of Public Health and Primary Care, Strangeways Research Laboratory, Wort's Causeway, Cambridge, CB1 8RN, UK. john.danesh@phpc.cam.ac.uk.
²² MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. sjg49@medschl.cam.ac.uk.
²³ The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, 2 Wort's Causeway, Cambridge, CB1 8RN, UK. sjg49@medschl.cam.ac.uk.

PMID: 26345710
PMCID: PMC4562192
DOI: 10.1186/s12889-015-2192-5

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.

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References

1. World Health Organization. Global status report on noncommunicable diseases 2010. 2011. http://whqlibdoc.who.int/publications/2011/9789240686458_eng.pdf?ua=1. Accessed 5 May 2014.
1. Mendis S, Puska P, Norrving B. Global atlas on cardiovascular disease prevention and control. World Health Organization. 2011. http://whqlibdoc.who.int/publications/2011/9789241564373_eng.pdf. Accessed 5 May 2014.
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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

Affiliations

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

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources