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.
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
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.


CONCLUSIONS
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.


BACKGROUND
Current Controlled Trials ISRCTN17721237 . Registered 12 January 2015.
MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. Barbora.Silarova@mrc-epid.cam.ac.uk.
Barbora
B
Silarova
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.
Joanne
J
Lucas
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.|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.
Adam S
AS
Butterworth
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.|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.
Emanuele
E
Di Angelantonio
Patient and Public Involvement representatives, Cambridge, UK. chrisgirling191086@gmail.com.
Christine
C
Girling
Patient and Public Involvement representatives, Cambridge, UK. kathryn.lawrence@ntlworld.com.
Kathryn
K
Lawrence
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.
Stuart
S
Mackintosh
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.|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.
Carmel
C
Moore
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.
Rupert A
RA
Payne
MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. stephen.sharp@mrc-epid.cam.ac.uk.
Stephen J
SJ
Sharp
MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. Guy.Shefer@mrc-epid.cam.ac.uk.
Guy
G
Shefer
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.|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.
Zoe
Z
Tolkien
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.
Juliet
J
Usher-Smith
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.|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.
Matthew
M
Walker
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.|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.
John
J
Danesh
MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge, CB2 0QQ, UK. sjg49@medschl.cam.ac.uk.|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.
Simon
S
Griffin
D000328:Adult; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D004739:England; D005260:Female; D017144:Focus Groups; D015438:Health Behavior; D006266:Health Education / Q000379:methods*; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D011322:Primary Prevention / Q000379:methods; D012107:Research Design; D012307:Risk Factors