- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340804
Effect of kcal and PACE Labelling on Self-served Portion Size
November 2, 2020 updated by: Eric Robinson, University of Liverpool
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See attached protocol documents.
Study Type
Interventional
Enrollment (Actual)
1800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L69 7ZA
- University of Liverpool
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- United Kingdom residents
- Age ≥ 18
- Fluent in English
- Have access to a computer and Internet
Exclusion Criteria:
- Have any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, diary or lactose free, food allergy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Kcal labelling
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).
|
Real-time kcal counter synchronised with the food amount changes
|
|
Experimental: PACE labelling
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.
|
Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes
|
|
Experimental: Kcal and PACE labelling
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).
|
Real-time kcal counter synchronised with the food amount changes
Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes
|
|
No Intervention: No labelling
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kcal influence
Time Frame: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
|
Whether kcal content influences the quantity of self-served food
|
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)
|
Whether physical activity energy equivalent influences the quantity of self-served food.
|
3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2020
Primary Completion (Actual)
April 13, 2020
Study Completion (Actual)
May 13, 2020
Study Registration Dates
First Submitted
April 7, 2020
First Submitted That Met QC Criteria
April 7, 2020
First Posted (Actual)
April 10, 2020
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 803194 1B4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Shared on the Open Science Framework
IPD Sharing Time Frame
On publication, indefinitely
IPD Sharing Access Criteria
Open website
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Study Data/Documents
- Study Protocol
- Statistical Analysis Plan
- Informed Consent Form
-
Individual Participant Data Set
Information comments: When results will be published
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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