Diet, HealthyNCT04340804
Effect of kcal and PACE Labelling on Self-served Portion Size
A study testing Kcal labelling and PACE labelling in people with Diet, Healthy and Food Selection, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
Participants will take part in an online survey. They will be asked to choose the amount of food they would like to eat based on pictures of 18 dishes sequentially displayed on the screen. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Food Selection
- What is being tested?
- Kcal labelling and PACE labelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2020to 13 May 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- United Kingdom residents
- Age ≥ 18
- Fluent in English
- Have access to a computer and Internet
Who cannot join
- Have any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, diary or lactose free, food allergy)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 7ZA
About this study
Official title: Socioeconomic Position and the Effect of kcal Labelling and PACE Labelling on Self-served Portion Size
Participants will take part in an online survey. They will be asked to choose the amount of food they would like to eat based on pictures of 18 dishes sequentially displayed on the screen. They will be randomly allocated to four different groups: kcal labelling, PACE labelling (Physical Activity Calorie Equivalent: minutes to walk to burn off the calories), kcal and PACE labelling combined, no labelling, in a between subject design. The main outcome variable is the total "self-served" energy for each dish (in kcal).
Read the detailed description
See attached protocol documents.
- Conditions
- Diet, Healthy, Food Selection
- Being tested
- Kcal labelling, PACE labelling
- Keywords
- kcal labelling, PACE labelling, portion size, socio-economic position
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kcal labellingBehavioural
Real-time kcal counter synchronised with the food amount changes
PACE labellingBehavioural
Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes
| Study group | Role | What they receive |
|---|---|---|
| Kcal labelling | Experimental | Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal counter synchronised with the food amount changes (i.e., increasing/decreasing). Receives: Behavioral: Kcal labelling |
| PACE labelling | Experimental | Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes (i.e., increasing/decreasing) with 4 min being equivalent to 20 kcal. Receives: Behavioral: PACE labelling |
| Kcal and PACE labelling | Experimental | Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal and PACE counters synchronised to the food amount changes (i.e., increasing/decreasing). Receives: Behavioral: Kcal labelling; Behavioral: PACE labelling |
| No labelling | No intervention | Participants allocated to this group will only see on the screen the amount of food increasing or decreasing based how many times they tap on the corresponding keys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total self-served energy (kcal)
Energy content of the portion selected for each dish.
Measured: 10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)
Secondary outcomes (2)
Kcal influence
Whether kcal content influences the quantity of self-served food
Measured: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
PACE influence
Whether physical activity energy equivalent influences the quantity of self-served food.
Measured: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start13 Apr 2020
- Primary completion13 Apr 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Robinson, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340804
- Sponsor's protocol ID
- 803194 1B4
- Status last verified
- Nov 2020
- First submitted
- 7 Apr 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared on the Open Science Framework
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Position and the Effect of kcal Labelling and PACE Labelling on Self-served Portion Size
- ClinicalTrials.gov ID
- NCT04340804
- Acronym / sponsor ID
- 803194 1B4
- Conditions
- Diet, Healthy, Food Selection
- Keywords
- kcal labelling, PACE labelling, portion size, socio-economic position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 10 Apr 2020 (actual)
- 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.
Participants will take part in an online survey. They will be asked to choose the amount of food they would like to eat based on pictures of 18 dishes sequentially displayed on the screen. They will be randomly allocated to four different groups: kcal labelling, PACE labelling (Physical Activity Calorie Equivalent: minutes to walk to burn off the calories), kcal and PACE labelling combined, no labelling, in a between subject design. The main outcome variable is the total "self-served" energy for each dish (in kcal).
Detailed description
See attached protocol documents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kcal labelling | Experimental | Behavioral: Kcal labellingParticipants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal counter synchronised with the food amount changes (i.e., increasing/decreasing). |
| PACE labelling | Experimental | Behavioral: PACE labellingParticipants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes (i.e., increasing/decreasing) with 4 min being equivalent to 20 kcal. |
| Kcal and PACE labelling | Experimental | Behavioral: Kcal labelling, Behavioral: PACE labellingParticipants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal and PACE counters synchronised to the food amount changes (i.e., increasing/decreasing). |
| No labelling | No intervention | –Participants allocated to this group will only see on the screen the amount of food increasing or decreasing based how many times they tap on the corresponding keys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- United Kingdom residents
- Age ≥ 18
- Fluent in English
- Have access to a computer and Internet
Key exclusion criteria (1 listed)
- Have any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, diary or lactose free, food allergy)
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 |
|---|---|---|
| Kcal labellingReal-time kcal counter synchronised with the food amount changes | Behavioural | Kcal and PACE labelling, Kcal labelling |
| PACE labellingReal-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes | Behavioural | Kcal and PACE labelling, PACE labelling |
Primary outcome
Total self-served energy (kcal)
Time frame: 10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)
Energy content of the portion selected for each dish.
2 secondary outcomes
Kcal influence
Time frame: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
PACE influence
Time frame: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
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 3 Nov 2020.
- Individual participant dataSharing planned: Yes. Shared on the Open Science Framework
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kcal labelling and PACE labelling in people with Diet, Healthy and Food Selection, run by University of Liverpool at 1 site in United Kingdom.
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 4 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 3 Nov 2020. 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 United Kingdom. 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?
Total self-served energy (kcal) (time frame: 10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)). 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 3 Nov 2020.