Evaluation of a CVD risk assessment tool for the promotion of healthier lifestyles

ISRCTN ISRCTN99445309
DOI https://doi.org/10.1186/ISRCTN99445309
Secondary identifying numbers UCR2007-1003
Submission date
17/05/2011
Registration date
26/05/2011
Last edited
30/07/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Robert Hurling
Scientific

Unilever Discover
Colworth Park
Sharnbrook
Bedfordshire
MK44 1LQ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of a CVD risk assessment tool for the promotion of healthier lifestyles: a randomised controlled trial
Study acronymCVD risk study
Study objectivesTo 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(s)Independent Ethics Committee in Unilever; South of England approved in December 2007
Health condition(s) or problem(s) studiedCardiovascular risk prevention
Intervention1. 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 typeOther
Primary outcome measureRisk perceptions were measured by self-reported items once participants received their CVD risk information
Secondary outcome measuresThe 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 study start date30/01/2008
Completion date28/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment30/01/2008
Date of final enrolment28/02/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Unilever Discover
Bedfordshire
MK44 1LQ
United Kingdom

Sponsor information

Unilever (UK)
Industry

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

ROR logo "ROR" https://ror.org/05n8ah907

Funders

Funder type

Industry

Unilever (UK)
Government organisation / For-profit companies (industry)
Alternative name(s)
Unilever Global, Unilever PLC, U
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2010 Yes No