Condition category
Circulatory System
Date applied
17/05/2011
Date assigned
26/05/2011
Last edited
30/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Percentage risk formats are commonly used to show cardiovascular disease (CVD) risk, but people can find them difficult to understand. The aim of this study is to compare the impact of providing a CVD risk message in either the traditional percentage risk format or using an analogy of risk (Heart-Age) on participants’ risk perceptions and intention to make lifestyle changes. The Heart-Age is the age corresponding to someone of the same gender with the same CVD risk level but with normal risk factors.

Who can participate?
A total of 400 healthy men and women who are obese and/or smokers and therefore at a higher risk of developing CVD.

What does the study involve?
Participants will be randomly allocated to one of two groups. In group 1, participants will receive their CVD risk in the percentage format. In group 2, participants will receive their CVD risk in the Heart-Age format. Participants' reactions will be measured after receiving this CVD risk information.

What are the possible benefits of participating?
Participants allocated to the Heart-Age risk message may gain a better understanding of their future risk of CVD and a higher intention to stop smoking, eat healthier and do more exercise. No potential side effects are expected as a result of this intervention.

Where is the study run from?
The study will be conducted online in the UK.

When is the study starting and how long is it expected to run for?
The study started in January 2008 and ran for 1 month.

Who is funding the study?
Unilever

Who is the main contact?
Dr Robert Hurling
robert.hurling@unilever.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Hurling

ORCID ID

Contact details

Unilever Discover
Colworth Park
Sharnbrook
Bedfordshire
MK44 1LQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UCR2007-1003

Study information

Scientific title

Evaluation of a CVD risk assessment tool for the promotion of healthier lifestyles: a randomised controlled trial

Acronym

CVD risk study

Study hypothesis

To compare the impact of providing a cardiovascular (CVD) risk message in either a traditional format (percentage risk) or using an analogy of risk (heart age) on participants' risk perceptions and intention to make lifestyle changes

Ethics approval

Independent Ethics Committee in Unilever; South of England approved in December 2007

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular risk prevention

Intervention

1. Each group has 200 participants
2. There will only be a single message provided and participants' reactions were measured after receipt of this CVD risk information:
Group 1: A percentage CVD risk message group, in which participants received an online risk message of their CVD risk in the format of a percentage
Group 2: A Heart-Age CVD risk communication message group, in which participants received an online risk message of their CVD risk in the format of a heart age (this is the age corresponding to someone of the same gender with the same CVD risk level but with normal risk factors)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Risk perceptions were measured by self-reported items once participants received their CVD risk information

Secondary outcome measures

The following were measured by self-reported items once participants received their CVD risk information:
1. Intention to stop smoking (for smokers only)
2. Eat healthier
3. Do more physical activity

Overall trial start date

30/01/2008

Overall trial end date

28/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Body mass index (BMI) above/and 30 and/or smoker
2. 30-60 years old, either sex
3. Not diagnosed with a heart condition (e.g. heart attack or angina)
4. Not diagnosed with cancer
5. Willing to sign the informed consent form
6. Computer and internet literate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. BMI < 29.9 and non-obese
2. <30 years old and >60 years old
3. Diagnosed with cancer
4. Diagnosed with a heart-condition (heart attack or angina). This is because algorithms predict risk of first CVD event, not recurrent events
5. Any other chronic disease of the major organs (e.g. kidney failure)
6. Not willing to sign online consent form
7. Not literate in use of computer and the internet

Recruitment start date

30/01/2008

Recruitment end date

28/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Unilever Discover
Bedfordshire
MK44 1LQ
United Kingdom

Sponsor information

Organisation

Unilever (UK)

Sponsor details

c/o Dr Robert Hurling
Unilever Discover
Colworth Park
Sharnbrook
Bedfordshire
MK44 1LQ
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Unilever (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20195154

Publication citations

  1. Results

    Soureti A, Hurling R, Murray P, van Mechelen W, Cobain M, Evaluation of a cardiovascular disease risk assessment tool for the promotion of healthier lifestyles., Eur J Cardiovasc Prev Rehabil, 2010, 17, 5, 519-523, doi: 10.1097/HJR.0b013e328337ccd3.

Additional files

Editorial Notes