General PopulationNCT01932840
Attitudes and Understanding of Plant Sterol Claims on Food Labels
An observational study of General Population and Consumer Research, run by University of Toronto at 1 site in Canada.
Trial summary
Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The Canadian government has recently allowed plant sterols to be added to certain foods and has also approved a disease risk reduction claim to be allowed on products containing plant sterols. Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- General Population, Consumer Research
- What is being tested?
- Mock package questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,017 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A subsection of the Canadian Consumer Monitor Panel - a national representative online consumer panel comprised of 30,000 Canadians
Who may be able to join
- Primary grocery shoppers
- Canadian adults between the ages 20 to 69 years
Who cannot join
- Did not have an active email address or access to internet
Trial locations and contacts
1 site in 1 country.
About this study
Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The Canadian government has recently allowed plant sterols to be added to certain foods and has also approved a disease risk reduction claim to be allowed on products containing plant sterols. However, it is unknown how Canadian consumers respond to plant sterol claims.
The objective of this study was to evaluate the attitudes and understanding of different types of plant sterol claims on food labels
- Conditions
- General Population, Consumer Research
- Being tested
- Mock package questionnaire
- Keywords
- attitudes and understanding of plant sterol claims, general Canadian population
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mock package questionnaireBehavioural
Within a online questionnaire we exposed participants randomly to 4 mock margarine packages differing only by the claim it carried and asked participants to answer several questions on attitudes and understanding after each mock package.
| Study group | Role | What they receive |
|---|---|---|
| Canadian Consumer Monitor Panel | Canadian Consumer Monitor Panel is an online panel which answer surveys every 8-10 weeks about diet and health Receives: Behavioral: Mock package questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to survey questions measuring attitudes towards plant sterol claims using 5-point likert rating scales
Within a online survey, participants were exposed to 4 mock margarine packages that differed only by the claim it carried. After being exposed to each mock package, participants were asked to rate their perceived attractiveness, healthiness, credibility, usefulness of the tested plant sterol claims using 5-point likert scales. Participants were also asked to rate their purchasing intentions of the mock margarine product with the different plant sterol claims.
Measured: On average the survey took 25 min to complete
Response to survey questions evaluating participants understanding of plant sterol claims
After each mock package, understanding of plant sterol claims was evaluated using various survey methods. First, participants were asked to rate their perceived clarity of the wording of the claim using a 5-point likert scale (a subjective measure of understanding). Second, participants were ask to rate, on 5-point likert scales, the perceived benefit of consuming the mock margarine package for subgroups with different health conditions (an indirect measure of understanding). Finally we asked participants, in an open ended question, to explain what a claim means to a friend (an objective measure of understanding).
Measured: On average the survey took 25 minutes to complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General PopulationStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Advance Foods and Materials Network
- Responsible party
- Principal investigator, Mary R. L'Abbé, University of Toronto
- Investigators
- Mary R L'Abbé, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932840
- Sponsor's protocol ID
- AFMnet-01
- Status last verified
- Aug 2013
- First submitted
- 27 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes and Understanding of Plant Sterol Claims on Food Labels
- ClinicalTrials.gov ID
- NCT01932840
- Acronym / sponsor ID
- AFMnet-01
- Conditions
- General Population, Consumer Research
- Keywords
- attitudes and understanding of plant sterol claims, general Canadian population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Advance Foods and Materials Network
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The Canadian government has recently allowed plant sterols to be added to certain foods and has also approved a disease risk reduction claim to be allowed on products containing plant sterols. However, it is unknown how Canadian consumers respond to plant sterol claims.
The objective of this study was to evaluate the attitudes and understanding of different types of plant sterol claims on food labels
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canadian Consumer Monitor Panel | – | Behavioral: Mock package questionnaireCanadian Consumer Monitor Panel is an online panel which answer surveys every 8-10 weeks about diet and health |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A subsection of the Canadian Consumer Monitor Panel - a national representative online consumer panel comprised of 30,000 Canadians
Key inclusion criteria (2 listed)
- Primary grocery shoppers
- Canadian adults between the ages 20 to 69 years
Key exclusion criteria (1 listed)
- Did not have an active email address or access to internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mock package questionnaireWithin a online questionnaire we exposed participants randomly to 4 mock margarine packages differing only by the claim it carried and asked participants to answer several questions on attitudes and understanding after each mock package. | Behavioural | Canadian Consumer Monitor Panel |
Primary outcome
Response to survey questions measuring attitudes towards plant sterol claims using 5-point likert rating scales
Time frame: On average the survey took 25 min to complete
Within a online survey, participants were exposed to 4 mock margarine packages that differed only by the claim it carried. After being exposed to each mock package, participants were asked to rate their perceived attractiveness, healthiness, credibility, usefulness of the tested plant sterol claims using 5-point likert scales. Participants were also asked to rate their purchasing intentions of the mock margarine product with the different plant sterol claims.
Response to survey questions evaluating participants understanding of plant sterol claims
Time frame: On average the survey took 25 minutes to complete
After each mock package, understanding of plant sterol claims was evaluated using various survey methods. First, participants were asked to rate their perceived clarity of the wording of the claim using a 5-point likert scale (a subjective measure of understanding). Second, participants were ask to rate, on 5-point likert scales, the perceived benefit of consuming the mock margarine package for subgroups with different health conditions (an indirect measure of understanding). Finally we asked participants, in an open ended question, to explain what a claim means to a friend (an objective measure of understanding).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary R L'Abbé, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Population and Consumer Research, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to survey questions measuring attitudes towards plant sterol claims using 5-point likert rating scales (time frame: On average the survey took 25 min to complete). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.