- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05623618
Understanding the Impact of Physical Activity Calorie Equivalent (PACE) Labelling in Secondary Schools
A Cluster Randomised Controlled Trial Testing Physical Activity Calorie Equivalent (PACE) Labelling on Discretionary Foods in Secondary Schools
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natalia Iris
- Phone Number: +44 (0)1509 226372
- Email: n.iris@lboro.ac.uk
Study Locations
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-
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Loughborough, United Kingdom
- Recruiting
- Loughborough University
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Contact:
- Natalia Iris
- Email: n.iris@lboro.ac.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Secondary schools:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (PACE labelling)
PACE labelling implemented near at least one discretionary food item in secondary school canteens for up to 6 weeks.
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PACE labelling implemented near at least one discretionary food item in secondary school canteens for up to 6 weeks.
|
|
No Intervention: Control (usual practice)
PACE labelling not implemented.
Secondary schools continue with their usual practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
Baseline period (a minimum of 4 weeks), Intervention period (up to 6 weeks) and Washout period (up to 6 weeks, and if time allows)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 7011 (Palo Alto Institute/Stanford University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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