Eating Behaviour of Discretionary FoodsNCT05623618
Understanding the Impact of Physical Activity Calorie Equivalent (PACE) Labelling in Secondary Schools
A study testing PACE labelling in people with Eating Behaviour of Discretionary Foods, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The aim is to undertake a cluster randomised controlled trial to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behaviour of Discretionary Foods
- What is being tested?
- PACE labelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2022to Feb 2023
- 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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Secondary schools that admit young people aged between 10 to 19 years.
- Sell at least one type of cake and/or at least one type of sweet biscuit for at least 2 days per week up to a 6 week period (or equivalent), and have sold the same cake(s)/biscuit(s) before the study (for a minimum of 4 weeks).
- Able to provide to the researcher with anonymised purchase data for study periods. Data to include number of units sold and dates sold of the chosen food item(s).
- A PACE label could feasibly be placed near to the study elected food item(s) in a school canteen used by students.
- Not participating in any other school trials or initiatives.
Who cannot join
- Secondary schools not meeting the inclusion criteria.
- Secondary schools that admit young people below the age of 10 years or above the age of 19 years.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Loughborough University
Loughborough
Natalia Iris, n.iris@lboro.ac.uk
About this study
Official title: A Cluster Randomised Controlled Trial Testing Physical Activity Calorie Equivalent (PACE) Labelling on Discretionary Foods in Secondary Schools
The aim is to undertake a cluster randomised controlled trial to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. Physical activity calorie equivalent (PACE) food labelling aims to show the number of minutes or miles/kilometres of physical activity equivalent to the calories contained in food/drinks.
Read the detailed description
Physical activity calorie equivalent (PACE) food labelling aims to show the number of minutes or miles/kilometres of physical activity equivalent to the calories contained in food/drinks. Evidence suggests that PACE food labelling may influence food/drink choice. Most research in this area however have tested PACE food labels with adults and/or have tested hypothetical food choice scenarios. Studies in real world contexts with young people are needed to see if PACE food labels could help them make healthier food choices.
The aim is to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. A cluster randomised controlled trial with a nested qualitative study will be conducted. Secondary schools will be randomised to either display PACE labelling near discretionary foods or continue with their usual practice. The intervention period will be up to 6 weeks. Anonymised purchase data will be collected throughout the study period.
Qualitative interviews will be conducted with students in the intervention schools to explore their views of the PACE labels such as perceived influence of the PACE labelling on their food selection.
- Conditions
- Eating Behaviour of Discretionary Foods
- Being tested
- PACE labelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACE labellingBehavioural
PACE labelling implemented near at least one discretionary food item in secondary school canteens for up to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (PACE labelling) | Experimental | PACE labelling implemented near at least one discretionary food item in secondary school canteens for up to 6 weeks. Receives: Behavioral: PACE labelling |
| Control (usual practice) | No intervention | PACE labelling not implemented. Secondary schools continue with their usual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of daily purchases/units sold of the specified discretionary food(s) in secondary school canteens.
Measured: Baseline period (a minimum of 4 weeks), Intervention period (up to 6 weeks) and Washout period (up to 6 weeks, and if time allows)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start28 Feb 2022
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating Behaviour of Discretionary FoodsStudies 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
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Natalia Iris
- Responsible party
- Principal investigator, Amanda Daley, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623618
- Sponsor's protocol ID
- 7011
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iris N, Munir F, Daley AJ. Physical activity calorie equivalent (PACE) food labelling on discretionary foods in secondary school canteens in England: an efficacy cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2025 Feb 26;22(1):24. doi: 10.1186/s12966-025-01710-1.
PubMed 40011948
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Controlled Trial Testing Physical Activity Calorie Equivalent (PACE) Labelling on Discretionary Foods in Secondary Schools
- ClinicalTrials.gov ID
- NCT05623618
- Acronym / sponsor ID
- 7011
- Conditions
- Eating Behaviour of Discretionary Foods
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Natalia Iris
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Nov 2022 (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.
The aim is to undertake a cluster randomised controlled trial to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. Physical activity calorie equivalent (PACE) food labelling aims to show the number of minutes or miles/kilometres of physical activity equivalent to the calories contained in food/drinks.
Detailed description
Physical activity calorie equivalent (PACE) food labelling aims to show the number of minutes or miles/kilometres of physical activity equivalent to the calories contained in food/drinks. Evidence suggests that PACE food labelling may influence food/drink choice. Most research in this area however have tested PACE food labels with adults and/or have tested hypothetical food choice scenarios. Studies in real world contexts with young people are needed to see if PACE food labels could help them make healthier food choices.
The aim is to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. A cluster randomised controlled trial with a nested qualitative study will be conducted. Secondary schools will be randomised to either display PACE labelling near discretionary foods or continue with their usual practice. The intervention period will be up to 6 weeks. Anonymised purchase data will be collected throughout the study period.
Qualitative interviews will be conducted with students in the intervention schools to explore their views of the PACE labels such as perceived influence of the PACE labelling on their food selection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (PACE labelling) | Experimental | Behavioral: PACE labellingPACE labelling implemented near at least one discretionary food item in secondary school canteens for up to 6 weeks. |
| Control (usual practice) | No intervention | –PACE labelling not implemented. Secondary schools continue with their usual practice. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Secondary schools that admit young people aged between 10 to 19 years.
- Sell at least one type of cake and/or at least one type of sweet biscuit for at least 2 days per week up to a 6 week period (or equivalent), and have sold the same cake(s)/biscuit(s) before the study (for a minimum of 4 weeks).
- Able to provide to the researcher with anonymised purchase data for study periods. Data to include number of units sold and dates sold of the chosen food item(s).
- A PACE label could feasibly be placed near to the study elected food item(s) in a school canteen used by students.
- Not participating in any other school trials or initiatives.
Key exclusion criteria (2 listed)
- Secondary schools not meeting the inclusion criteria.
- Secondary schools that admit young people below the age of 10 years or above the age of 19 years.
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 labellingPACE labelling implemented near at least one discretionary food item in secondary school canteens for up to 6 weeks. | Behavioural | Intervention (PACE labelling) |
Primary outcome
Change in number of daily purchases/units sold of the specified discretionary food(s) in secondary school canteens.
Time frame: Baseline period (a minimum of 4 weeks), Intervention period (up to 6 weeks) and Washout period (up to 6 weeks, and if time allows)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Derived from this study: PubMed 40011948Iris N, Munir F, Daley AJ. Physical activity calorie equivalent (PACE) food labelling on discretionary foods in secondary school canteens in England: an efficacy cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2025 Feb 26;22(1):24. doi: 10.1186/s12966-025-01710-1.
- Individual participant dataSharing planned: No
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.
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 labelling in people with Eating Behaviour of Discretionary Foods, 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia Iris (+44 (0)1509 226372, n.iris@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of daily purchases/units sold of the specified discretionary food(s) in secondary school canteens. (time frame: Baseline period (a minimum of 4 weeks), Intervention period (up to 6 weeks) and Washout period (up to 6 weeks, and if time allows)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05623618, which also lists 1 linked publication.
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 21 Nov 2022.