Will providing different types of coronary heart disease risk information result in a change in lifestyle?

Not Applicable

Completed

• Conditions: Coronary Heart Disease; Circulatory System

• Registration Number: ISRCTN17721237
• Lead Sponsor: niversity of Cambridge

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26345710 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27914472 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29898701 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30928969/ (added 08/02/2023) 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30352317/ (added 08/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-12
• Study Completion: 2015-12-31
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 956

Inclusion Criteria

1. Age = 40 and = 84 years
2. Have been participating in and completed the two year follow-up questionnaire for the INTERVAL Study (ISRCTN24760606), and not exiting that study due to withdrawal or lost to follow up
3. Able and willing to wear a physical activity monitoring device on the wrist
4. Willing to provide a blood sample
5. Have sufficient data available to the study team for calculation of phenotypic and genetic risk estimates for fatal and non-fatal heart attack
6. Agree to allow trial staff to contact his or her GP to notify them of trial participation and study test results
7. Have internet access and be willing to provide an email address for study correspondence
8. Have a good understanding of the English language, both written and oral (study materials are not tailored to support non-English language speakers)

Exclusion Criteria

1. Prior history of cardiovascular disease (heart attack, angina, peripheral arterial disease or stroke, surgical or percutaneous coronary revascularisation procedure)
2. Medical condition or disability that means the participant can not engage in physical activity
3. Known pregnancy at time of recruitment
4. Unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objectively measured physical activity using an Axivity AX3 3-Axis Logging Accelerometer®, defined as average acceleration (m/s2) over a 12 -week observation period.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Objectively measured dietary behaviour: serum carotenoid levels<br> 2. Cardiovascular risk factors: objectively measured total-, high density lipoprotein-, and low-density lipoprotein-cholesterol, triglycerides and fructosamine; self-reported weight, smoking status, alcohol consumption, physical activity and dietary behaviour<br> 3. Current self-reported medication and healthcare usage<br> 4. Perceived risk: comparative and absolute perception of risk<br> 5. Cognitive evaluation of provision of cardiovascular risk scores: participant’s acceptability and understanding, of the risk scores and accuracy of their risk perception<br> 6. Psychological outcomes: anxiety associated with testing, fatalism, depression, stress and mood<br> 7. Current participation in other interventional clinical trials in cardiovascular disease or lifestyle modification<br>