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

Information and Risk Modification Trial (INFORM): A randomised trial to determine if communicating different forms of coronary heart disease risk information and lifestyle advice for risk reduction results in health-related behaviour change.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17721237
Enrollment
932
Registered
2015-01-12
Start date
2015-01-26
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease Circulatory System Coronary Heart Disease

Interventions

Participants are randomly allocated to one of four groups: Intervention Group A: Participants receive phenotypic and genetic coronary heart disease risk scores. The genetic risk estim

Sponsors

University of Cambridge
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Objectively measured dietary behaviour: serum carotenoid levels 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 3. Current self-reported medication and healthcare usage 4. Perceived risk: comparative and absolute perception of risk 5. Cognitive evaluation of provision of cardiovascular risk scores: participant’s acceptability and understanding, of the risk scores and accuracy of their risk perception 6. Psychological outcomes: anxiety associated with testing, fatalism, depression, stress and mood 7. Current participation in other interventional clinical trials in cardiovascular disease or lifestyle modification

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026