Health BehaviorNCT05143515
The Effectiveness of PACE Label on Reducing Food Consumption and Increasing Physical Activity Levels
A study testing PACE label in people with Health Behavior, run by Loughborough University at 1 site in United Kingdom.
Trial summary
Background: More people are at the risk of chronic disease as the prevalence of obesity increases. It is therefore essential to find ways of helping consumers to make a lower calorie food choice. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- PACE label
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2019to 30 Jul 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years old
- healthy
Who cannot join
- allergic to the foods in the pop up café
- chronic disease such as insulin-dependent diabetes
- BMI lower than 16 kg/m2.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicester, LE113TU
About this study
Official title: The Effectiveness of Physical Activity Calorie Equivalent (PACE) Label on Reducing Food Consumption and Increasing Physical Activity Levels: a Randomized Controlled Trial
Background: More people are at the risk of chronic disease as the prevalence of obesity increases. It is therefore essential to find ways of helping consumers to make a lower calorie food choice. Current evidence indicates that current food labelling is changing food choices and consumption, but it is of limited effectiveness. Purpose: The purpose of this study is to assess the efficacy of physical activity calorie equivalent (PACE) food labelling on food selection and consumption using a randomised experimental design in pop-up café. Method: This study as a randomised controlled experimental trial (RCT) was conducted in a research kitchen at Loughborough University. Participants were blinded to the exact purpose of the study and randomised to either exposure to PACE labelling plus calorie food labelling or calorie labelling only and asked to select food/drinks for their consumption, in the pop-up café up to a maximum value cost of £10. The study outcomes were the amount of money spent, the number of calories selected, and the amount of food consumed after exposure to the two different types of food labels.
- Conditions
- Health Behavior
- Being tested
- PACE label
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACE labelBehavioural
There were 34 food and drinks choices available for consumption in the pop up café. The labels were displayed next to the food/drink item in the pop up café. The food items were kept in the same position for each participant kitchen to simulate the café environment. Then researchers changed the labels on the display according to the randomisation allocation of each participant. After randomsation participants were informed that they have £10 to spend in the pop-up café and that they could eat the food they selected in a private social eating room.
| Study group | Role | What they receive |
|---|---|---|
| PACE Label group | Experimental | This group used the PACE label plus calorie label to help participants to know about the number of minutes of walking or running required to burn off the calories in food and drinks. Receives: Behavioral: PACE label |
| Calorie Label group | No intervention | This group used only calorie labels to show the number of calories in food and drinks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Money Spent
Participants had £10 to spend in the pop-up café and they could eat the food they selected in a private social eating room. The total money they spent were measured when they left the lab.
Measured: Immediately after the intervention
Calorie Intake
The researchers used a digital scale to weigh the original remaining food to the nearest 0.1 gram. The name of food items, the number of calories in each item selected, and the weight of leftover (using calibrated food weighing scales) was recorded for each participant. They were to ensure that all participants had finished eating and left the lab before weighing the remaining food.
Measured: Immediately after the intervention
The International Physical Activity Questionnaires(IPAQ)
24-hour physical activity questionnaire was sent to them via email one day after the experiment.
Measured: 24 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start4 Jul 2019
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuo Zhang, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143515
- Sponsor's protocol ID
- ZhangNuo
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Physical Activity Calorie Equivalent (PACE) Label on Reducing Food Consumption and Increasing Physical Activity Levels: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05143515
- Acronym / sponsor ID
- ZhangNuo
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 3 Dec 2021 (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.
Background: More people are at the risk of chronic disease as the prevalence of obesity increases. It is therefore essential to find ways of helping consumers to make a lower calorie food choice. Current evidence indicates that current food labelling is changing food choices and consumption, but it is of limited effectiveness. Purpose: The purpose of this study is to assess the efficacy of physical activity calorie equivalent (PACE) food labelling on food selection and consumption using a randomised experimental design in pop-up café. Method: This study as a randomised controlled experimental trial (RCT) was conducted in a research kitchen at Loughborough University. Participants were blinded to the exact purpose of the study and randomised to either exposure to PACE labelling plus calorie food labelling or calorie labelling only and asked to select food/drinks for their consumption, in the pop-up café up to a maximum value cost of £10. The study outcomes were the amount of money spent, the number of calories selected, and the amount of food consumed after exposure to the two different types of food labels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACE Label group | Experimental | Behavioral: PACE labelThis group used the PACE label plus calorie label to help participants to know about the number of minutes of walking or running required to burn off the calories in food and drinks. |
| Calorie Label group | No intervention | –This group used only calorie labels to show the number of calories in food and drinks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years old
- healthy
Key exclusion criteria (3 listed)
- allergic to the foods in the pop up café
- chronic disease such as insulin-dependent diabetes
- BMI lower than 16 kg/m2.
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 |
|---|---|---|
| PACE labelThere were 34 food and drinks choices available for consumption in the pop up café. The labels were displayed next to the food/drink item in the pop up café. The food items were kept in the same position for each participant kitchen to simulate the café environment. Then researchers changed the labels on the display according to the randomisation allocation of each participant. After randomsation participants were informed that they have £10 to spend in the pop-up café and that they could eat the food they selected in a private social eating room. | Behavioural | PACE Label group |
Primary outcome
Money Spent
Time frame: Immediately after the intervention
Participants had £10 to spend in the pop-up café and they could eat the food they selected in a private social eating room. The total money they spent were measured when they left the lab.
Calorie Intake
Time frame: Immediately after the intervention
The researchers used a digital scale to weigh the original remaining food to the nearest 0.1 gram. The name of food items, the number of calories in each item selected, and the weight of leftover (using calibrated food weighing scales) was recorded for each participant. They were to ensure that all participants had finished eating and left the lab before weighing the remaining food.
The International Physical Activity Questionnaires(IPAQ)
Time frame: 24 hours after the intervention
24-hour physical activity questionnaire was sent to them via email one day after the experiment.
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 Dec 2021.
- Individual participant dataSharing planned: No
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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 PACE label in people with Health Behavior, run by Loughborough University 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 2 inclusion and 3 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 Dec 2021. 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?
Money Spent (time frame: Immediately after the intervention). The study lists 3 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 3 Dec 2021.