Evaluation of a CVD risk assessment tool for the promotion of healthier lifestyles
ISRCTN | ISRCTN99445309 |
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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
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
Scientific
Unilever Discover
Colworth Park
Sharnbrook
Bedfordshire
MK44 1LQ
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Evaluation of a CVD risk assessment tool for the promotion of healthier lifestyles: a randomised controlled trial |
Study acronym | CVD risk study |
Study objectives | 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(s) | Independent Ethics Committee in Unilever; South of England approved in December 2007 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 30/01/2008 |
Completion date | 28/02/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 400 |
Key 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 |
Key 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 |
Date of first enrolment | 30/01/2008 |
Date of final enrolment | 28/02/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MK44 1LQ
United Kingdom
Sponsor information
Industry
c/o Dr Robert Hurling
Unilever Discover
Colworth Park
Sharnbrook
Bedfordshire
MK44 1LQ
United Kingdom
https://ror.org/05n8ah907 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Unilever Global, Unilever PLC, U
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/10/2010 | Yes | No |