- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06923241
Nutri-score Labelling in a UK Restaurant Setting: a Randomised Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Merseyside
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Liverpool, Merseyside, United Kingdom, L69 7ZA
- University of Liverpool
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Can visit a restaurant in Liverpool city centre
- Regularly eat food prepared out of the home (from restaurants, cafes, fast food etc., at least once a month)
- Over the age of 18 years
- Fluent English speaker
Exclusion Criteria:
- Pregnant/breastfeeding
- You have been diagnosed with a current or historic eating disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Restaurant 1
Restaurant 1: plant-based cafe
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Participants will be given a restaurant's menu with calorie information or a menu with calorie information and NS labelling.
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Active Comparator: Restaurant 2
Restaurant 2: University cafe
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Participants will be given a restaurant's menu with calorie information or a menu with calorie information and NS labelling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Message Effectiveness
Time Frame: Up to 30 weeks
|
An adapted version of the University of North Carolina PME scale will be used to measure health concern, product attitude, and discouragement of item consumption in response to the food menu.
Participants will be given the menu they ordered from to look at.
All participants will answer 3 questions using a Likert scale ranging from 1 - 5 anchored by "not at all" and "a great deal".
The mean response to the three items will be calculated.
PME is used as an early indicator of a health message's potential to change behaviour (e.g., reduce selection of less healthy items).
The scale has been used previously to identify the potential impact of food labels and is predictive of long-term behaviour.
|
Up to 30 weeks
|
|
Nutritional quality of each item and for the full meal
Time Frame: Up to 30 weeks
|
Nutritional quality for meal choices will be calculated using the UK NPM scoring system. This calculates a score (continuous variable) for a product by deducting a total score for positive nutrients from a total score for negative nutrients. A lower score represents greater nutritional quality and a higher score represents poorer nutritional quality. We will calculate the mean NPM score weighted by energy content of items for each participant. This will ensure that the NPM score of main dishes will be weighted higher than that of starters or sides (assuming energy content of selected main is higher than any starters or sides), leading to a more representative overall NPM score for food orders. This will be done using the weighted.mean function in R. This function multiplies each value (i.e. NPM scores for individual items) by its corresponding weight (kcal content of individual items), sums all items and then divides this by the sum of the weights. |
Up to 30 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NS label of each item selected
Time Frame: Up to 30 weeks
|
A NS category value will be recorded for each item selected by participants (A,B,C,D,E)
|
Up to 30 weeks
|
|
Energy content of all food ordered
Time Frame: Up to 30 weeks
|
The sum of energy (kcal) across all foods ordered for the meal will be calculated
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Up to 30 weeks
|
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Energy and nutrients consumed
Time Frame: Up to 30 weeks
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Researchers will take pictures of plates before and after each item is given to participants. Researchers will estimate the percentage of each dish consumed. Participants will be asked whether they shared any of their meal with someone else and this will be taken into account when making percentage estimates. A random 10% of percentage estimates will be performed by a second researcher to measure reliability. Energy and nutrient consumption will be calculated by multiplying the total energy/nutritional content of food items selected/consumed by the estimated proportion of the item consumed. Nutrients explored will be salt, sugar, fat, saturated fat, protein and fibre. |
Up to 30 weeks
|
|
Later intake
Time Frame: Up to 30 weeks
|
The morning after participants take part in the study, they will be emailed with a link to complete a dietary recall survey (via intake 24, https://intake24.co.uk/).
Participants will report everything they ate after the study session up until they went to bed.
They will be asked to provide as much detail as possible on what they had for dinner, snacks, and drinks after the study session.
We will estimate based on data from Intake 24, later consumption (kcal, salt, fat, saturated fat, sugar, protein, fibre).
|
Up to 30 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric Robinson, University of Liverpool
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- NS in the OOHFS study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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