- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07423845
Nutri-score Labels on the Nutritional Quality of Out-of-home Food Selection
The Impact of Nutri-score Labels on the Nutritional Quality of Out-of-home Food Selection in a Delivery Platform Setting: An Online Randomised Controlled Trial
Study Overview
Status
Conditions
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:
- Aged 18+
- Frequent user of food delivery platforms (at least once a month on average)
- Can complete the study on a laptop or desktop
Exclusion Criteria:
- Current or previous diagnosis of an eating disorder
- Currently on appetite supressing medication
- No dietary restrictions including dairy free, sugar free, gluten free (vegetarians and vegans are eligible to participate)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control
Participants will be presented with a menu with calorie labelling only
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Participants will be asked to choose a meal through a virtual delivery app where four outlets are presented.
Participants will be provided with a menu with calorie labelling.
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Experimental: Nutri-score labelling
Participants will be presented with a menu with calorie labelling and Nutri-score labelling
|
Participants will be asked to choose a meal through a virtual delivery app where four outlets are presented.
Participants will be given menus with calorie and Nutri-score labelling.
|
|
Experimental: Nutri-score labelling + educational intervention
Participants will be presented with a menu with calorie labelling and Nutri-score labelling.
Prior to the food choice task, participants will read an article on Nutri-score as an educational intervention.
|
Participants will be asked to choose a meal through a virtual delivery app where four outlets are presented. Participants will be given menus with calorie and Nutri-score labelling. Prior to selecting their meal, participants will be asked to read an article about Nutri-score. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthiness of selected meal
Time Frame: Day 1 of 1: Food orders (item names, energy content, UK Nutrient Profiling Model scores) will be recorded immediately after the baseline questionnaire. The recorded information will be used to calculate weighted NPM scores.
|
In line with published research into Nutri-score, the investigators will assess the healthiness of meals using UK Nutrient Profiling Model (NPM) scores(16). These scores are calculated in a similar way to Nutri-score, whereby the total value of positive nutrients is subtracted from the total value of negative nutrients. Lower scores represent healthier items. Scores range from -15 (healthiest) to 40 (least healthy). To account for the likely event of multiple items being selected to form a meal, the investigators will calculate a mean NPM score, weighted by the energy content of individual food items. This will be done using the 'weighted.mean'(37) function in R grouped by participant so the weights are specific to individual orders. The following code will be used for this: weighted_ppt<-combine %>% group_by(ppt) %>% summarise(score = weighted.mean(nutriscore, meal_kcal)) |
Day 1 of 1: Food orders (item names, energy content, UK Nutrient Profiling Model scores) will be recorded immediately after the baseline questionnaire. The recorded information will be used to calculate weighted NPM scores.
|
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Nutri-score label of selected food items
Time Frame: Day 1 of 1: Food orders (item names, NS values) will be recorded immediately after the baseline questionnaire when participants select their food orders.
|
Nutri-score values of each menu item were calculated prior to creating the online ordering platform. To calculate overall scores, the total value of positive nutrients is subtracted from the total value of negative nutrients. Lower scores represent healthier items. Thresholds are used to dictate the Nutri-score value assigned to items, with A (healthiest) to E (least healthy) When participants complete the food choice task, the Nutri-score labels (A-E) of each item selected by participants will be recorded by the online platform. |
Day 1 of 1: Food orders (item names, NS values) will be recorded immediately after the baseline questionnaire when participants select their food orders.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy content of all food ordered
Time Frame: Day 1 of 1: The energy content selected by participants will be recorded immediately after the baseline questionnaire when participants select their food orders.
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The total energy content (kcal) of food items selected by participants will be recorded by the online study platform.
Nutritional information to inform this was taken from the food outlet websites.
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Day 1 of 1: The energy content selected by participants will be recorded immediately after the baseline questionnaire when participants select their food orders.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health food choice motives
Time Frame: Day 1 of 1: The Food Choice Motives questionnaire will be completed immediately after participants make their food choice.
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The Food Choice Questionnaire(45) is comprised of 36 items across nine factors (health, mood, convenience, sensory appeal, natural content, price, weight control, familiarity & ethical concern).
Participants are required to respond to the statement ''It is important to me that the food I eat on a typical day…" for each item (e.g.
"Is nutritious", "tastes good") on a scale of 1 to 4 labelled not at all important, a little important, moderately important and very important.
The average score for each factor is calculated.
The health motive score will assess whether the value of health is associated with the impact of Nutri-score labelling on participant food choices.
In the development of the food choice motives questionnaire, the Health Factor had a Cronbach's alpha value of 0.87, suggesting excellent internal consistency.
Convergent validity of the health factor has also been shown by positive significant associations with health as a value and internal health-related locus
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Day 1 of 1: The Food Choice Motives questionnaire will be completed immediately after participants make their food choice.
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Height & weight
Time Frame: Day 1 of 1: Height and weight data will be collected in the follow-up questionnaire, immediately after participants make their food choice.
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Participants will report their height and weight, which will be used to calculate participant BMI.
In line with previous research(39), heights below 122cm or above 213cm, and weights below 34kg or above 227kg will be deemed implausible and excluded from descriptive statistics.
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Day 1 of 1: Height and weight data will be collected in the follow-up questionnaire, immediately after participants make their food choice.
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Socioeconomic position (SEP)
Time Frame: Day 1 of 1: Participants will report their annual household income and highest level of education in the baseline questionnaire, immediately prior to the food choice task.
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Participants will report their total annual household income on a 9-point scale: 1) ≤£5199; 2) £5,200 - £10,399; 3) £10,400 - £15,599; 4) £15,600 - £20,799; 5) £20,800 - £25,999; 6) £26,000 - £36,399; 7) £36,400 - £51.999; 8) £52,000 - £77,999; 9) ≥ £78,000. Participants will also report their highest level of education achieved on an 8-point scale: 1) none; 2) GCSE Grade D or below; 3) GCSE Grade C or above; 4) A-level or equivalent; 5) University degree or equivalent; 6) Postgraduate qualification or equivalent; 7) Master's degree or equivalent; 8) PhD or equivalent. Similar to previous research(40), a composite score made up of household income and education will be used as a measure of participant SEP. This will be done by summing the points scored for each measure. Higher scores indicate a higher level of socioeconomic position. |
Day 1 of 1: Participants will report their annual household income and highest level of education in the baseline questionnaire, immediately prior to the food choice task.
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Social desirability scale
Time Frame: Day 1 of 1: The social desirability scale will be provided at the end of the follow-up questionnaire immediately after the food choice task.
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To identify whether our findings could be influenced by social desirability, the 13-item Marlowe-Crowne Social Desirability Scale will be included at the end of the follow-up questionnaire(41).
Each participants will receive a Social desirability score from 0 (low social desirability bias) to 13 (high social desirability bias).
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Day 1 of 1: The social desirability scale will be provided at the end of the follow-up questionnaire immediately after the food choice task.
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Collaborators and Investigators
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NS consortium 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
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