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Original research article
Effect of communicating phenotypic and genetic risk of coronary heart disease alongside web-based lifestyle advice: the INFORM Randomised Controlled Trial
  1. Barbora Silarova1,
  2. Stephen Sharp1,
  3. Juliet A Usher-Smith2,
  4. Joanne Lucas3,
  5. Rupert A Payne4,5,
  6. Guy Shefer1,
  7. Carmel Moore3,6,
  8. Christine Girling7,
  9. Kathryn Lawrence7,
  10. Zoe Tolkien3,
  11. Matthew Walker3,6,
  12. Adam Butterworth3,6,
  13. Emanuele Di Angelantonio3,6,
  14. John Danesh3,6,
  15. Simon J Griffin1,2
  1. 1 MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge, UK
  2. 2 Department of Public Health and Primary Care, The Primary Care Unit, Cambridge, UK
  3. 3 Department of Public Health and Primary Care, MRC/BHF Cardiovascular Epidemiology Unit, Cambridge, UK
  4. 4 University of Bristol Centre for Academic Primary Care, Bristol, Bristol, UK
  5. 5 Institute of Public Health, Cambridge Centre for Health Services Research, Cambridge, UK
  6. 6 Department of Public Health and Primary Care, NIHR Blood and Transplant Research Unit in Donor Health and Genomics, Cambridge, UK
  7. 7 Patient and Public Involvement representative, Cambridge, UK
  1. Correspondence to Dr Barbora Silarova, MRC Epidemiology Unit, School of Clinical Medicine, Institute of Metabolic Science, University of Cambridge, Cambridge CB1 9NL, UK; B.Silarova{at}exeter.ac.uk and Professor Simon J Griffin, The Primary Care Unit, Department of Public Health andPrimary Care, University of Cambridge, Institute of Public Health, Universityof Cambridge, School of Clinical Medicine, Box 113, Cambridge Biomedical Campus,Cambridge, Cambridgeshire CB2 0SR, United Kingdom; ProfGP{at}medschl.cam.ac.uk

Abstract

Objective To determine whether provision of web-based lifestyle advice and coronary heart disease risk information either based on phenotypic characteristics or phenotypic plus genetic characteristics affects changes in objectively measured health behaviours.

Methods A parallel-group, open randomised trial including 956 male and female blood donors with no history of cardiovascular disease (mean [SD] age=56.7 [8.8] years) randomised to four study groups: control group (no information provided); web-based lifestyle advice only (lifestyle group); lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic characteristics (phenotypic risk estimate) (phenotypic group) and lifestyle advice plus information on estimated 10-year coronary heart disease risk based on phenotypic (phenotypic risk estimate) and genetic characteristics (genetic risk estimate) (genetic group). The primary outcome was change in physical activity from baseline to 12 weeks assessed by wrist-worn accelerometer.

Results 928 (97.1%) participants completed the trial. There was no evidence of intervention effects on physical activity (difference in adjusted mean change from baseline): lifestyle group vs control group 0.09 milligravity (mg) (95% CI −1.15 to 1.33); genetic group vs phenotypic group −0.33 mg (95% CI −1.55 to 0.90); phenotypic group and genetic group vs control group −0.52 mg (95% CI −1.59 to 0.55) and vs lifestyle group −0.61 mg (95% CI −1.67 to 0.46). There was no evidence of intervention effects on secondary biological, emotional and health-related behavioural outcomes except self-reported fruit and vegetable intake.

Conclusions Provision of risk information, whether based on phenotypic or genotypic characteristics, alongside web-based lifestyle advice did not importantly affect objectively measured levels of physical activity, other health-related behaviours, biological risk factors or emotional well-being.

Trial registration number ISRCTN17721237; Pre-results.

  • heart disease
  • coronary artery disease
  • cardiac risk factors and prevention

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Footnotes

  • Contributors Study concept and design: BS, JAU-S, JL, RAP, GS, ZT, CM, AB, EDA, JD, SJG. Acquisition, analysis or interpretation of data: BS, SS, RAP, MW, SJG. Drafting of the manuscript: BS, SS, SJG. Critical revision of the manuscript for important intellectual content: BS, SS, JAU-S, JL, RAP, GS, SJG, KL, ZT, CM, MW, AB, EDA, JD, SJG. Obtained funding: JD, SJG. Administrative, technical or material support: BS, JL, RAP, GM, MW, JD, SJG. Study supervision: BS, JAU-S, JL, RAP, GS, ZT, CM, AB, EDA, SJG. SJG (principal investigator) and BS had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

  • Funding This work was supported by a European Commission Framework 7 EPIC-CVD Grant agreement no: 279233. NHS Blood and Transplant funded the INTERVAL trial. DNA extraction and genotyping in INTERVAL/INFORM was funded by the National Institute for Health Research. The coordinating team for INTERVAL/INFORM at the Cardiovascular Epidemiology Unit of the University of Cambridge was supported by core funding from: UK Medical Research Council (G0800270), British Heart Foundation (SP/09/002), British Heart Foundation Cambridge Cardiovascular Centre of Excellence and UK National Institute for Health Research Cambridge Biomedical Research Centre. BS was supported by the Medical Research Council (MC_UU_12015/4). JD is a British Heart Foundation Professor, European Research Council Senior Investigator and National Institute of Health Research Senior Investigator. SJG is a National Institute of Health Research Senior Investigator and member of the NIHR School for Primary Care Research. The University of Cambridge has received salary support in respect of SJG from the NHS in the East of England through the Clinical Academic Reserve.

  • Disclaimer All authors declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

  • Competing interests None declared.

  • Ethics approval Ethical approval was received from the National Research Ethics Service Committee East of England—Cambridge Central (14/EE/1164) on 3 December 2014.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Patient level data and statistical code are available from the corresponding author at ProfGP@medschl.cam.ac.uk.

  • Patient consent for publication Obtained.

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