NCT07809295

Brief Summary

Calorie labelling in out-of-home (OOH) settings was introduced by the government in England as part of a wider strategy to 'tackle obesity' (DHSC, 2020). The OOH sector encompasses outlets where food and drinks are prepared for immediate consumption, on or off the premises (DHSC, 2021). Increased consumption of OOH food is associated with greater intake of energy and nutrients of concern; therefore, is implicated in poorer dietary quality and ill-health (Gesteiro et al., 2022). The key ambition for the calorie labelling policy was to inform consumers of the calorie content of their food choices, making it easier to select healthier food choices (DHSC, 2020). An additional potential benefit of the policy was to prompt reformulation by the food industry to either reduce the calorie content of foods on offer or provide new lower calorie options (DHSC, 2021). The calorie labelling policy in England was criticised at the time of implementation in the media for its potential to cause harm in individuals with eating disorders (Polden et al., 2023). However, limited research had explored effects on individuals with eating disorders (Robinson et al., 2023). It is estimated that over a million individuals in the UK are living with an eating disorder (Beat Eating disorders, 2026). Therefore, it is important for research to understand the impact of food labelling interventions on mental health outcomes in individuals with eating disorders and other mental health conditions, and whether alternative nutritional labelling practices that are not focused on calories alone could have positive health impacts without unintended negative consequences. One alternative form of nutritional labelling that could be considered in OOH settings is Nutri-score. Nutri-score provides food items with a label from A (dark green, healthiest) to E (Red, least healthy) according to the content of both positive (e.g. fibre, protein) and negative (e.g. saturated fat, salt, sugar) nutrients. Nutri-score has been implemented as a front-of-pack label in several countries across Europe, with positive impacts on the healthiness of food purchasing in supermarkets (Andreani et al., 2025). Two studies have assessed Nutri-score in OOH settings, also finding associations between Nutri-score and healthier food choices (Chandon \& Indaburu, 2026; Julia et al., 2021). However, Nutri-score on food menus has not previously been examined in terms of the potential impact on individuals with eating disorders and other mental health outcomes. Nutri-score encompasses the nutritional quality of a food product, by accounting for both positive and negative components. This may be less harmful to individuals with eating disorders as it would remove the focus on calorie content. Previous qualitative research has shown that individuals with eating disorders may support labelling strategies that provide more holistic approaches to nutrition (Trompeter et al., 2026). It could also be of benefit to general population health to focus on helping individuals to consume a well-rounded diet higher in positive nutrients (fibre, protein), with high fruit, vegetable and nut content, and lower in negative nutrients that contribute to ill health (salt, sugar, fats). To date, limited research has compared Calorie labelling to Nutri-score in the general population or among those living with mental health conditions, like eating disorders. OBJECTIVES This new study will explore the impact of Nutri-score labelling vs Calorie labelling vs no labelling (Control) in a simulated OOH food delivery ordering platform (common setting for food purchasing and calorie labelling is required by law in England) on participants' perceived effectiveness of nutritional labelling, healthiness of food choices, positive and negative affect, and perceived impacts on mental health. We will examine effects in a general population sample (no eating disorder diagnosis), a sample of participants with a past or current diagnosis of an eating disorder by a medical practitioner and a sample of participants with a common mental health condition diagnosed by a medical practitioner without eating disorder (e.g., anxiety), in order to understand potential effects across groups of participants who may differ in their risk of poorer mental health in response to nutritional labelling. (references in attached protocol)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
Last Updated

September 9, 2026

Status Verified

August 1, 2026

Enrollment Period

Same day

First QC Date

August 26, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

ObesityFood policyNutritional labellingFood choice

Outcome Measures

Primary Outcomes (6)

  • Perceived Message Effectiveness

    An adapted version of the University of North Carolina Perceived Message Effectiveness (PME) scale will be used as a measurement of how effective participants believe nutritional labelling is in promoting behaviour change. The scale measures health concern, product attitude, and discouragement of item consumption in response to public health messaging or in this context, the food menu presented during the study. Participants will be shown a screenshot of the menu they ordered. All participants will answer 3 questions using a Likert scale ranging from 1 - 5 anchored by "Strongly disagree" and "Strongly agree". The mean response to the three items will be calculated. PME is used as an early indicator of a health messages 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.

    Day 1 of 1: the PME measure will be completed immediately after participants have made their food selection

  • Perceived usefulness of menu in identifying healthier/less healthy food choices

    Participants will be asked 'To what extent was the menu useful in helping you identify healthy vs. less healthy food choices'. Participants will select their answer on a Likert scale ranging from 1 - 5 anchored by "Strongly disagree" and "Strongly agree".

    Day 1 of 1: Participants will rate the perceived usefulness of the menu immediately after making their food selection.

  • Nutritional quality of food ordered

    An overall measure of nutritional quality of participants food order will be calculated using mean UK NPM scores of individual items, weighted according to the energy content of the item. Nutritional content used to calculate NPM scores for each menu item was obtained from outlet websites and input into the online NPM calculation tool (2004/05). Weighted scores will be calculated using the weighted.mean function in R.

    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.]

  • Positive/negative affect

    Participants will complete an adapted version of PANAS after completing the food selection task. This is a 20-item measure, whereby participants will be asked to 'indicate the extent you feel this way right now' on a scale of 1 to 5 from 'very slightly or not at all' to 'extremely'. Participants receive a positive affect score and a negative affect score.

    Day 1 of 1: Participants will complete the PANAS measure immediately after making their food selection

  • Perceived impact of labelling on mental health

    Questions were developed based on self-reported mental health-related outcomes in previous research. Participants will be asked to respond to each of the following points on a scale of 1 to 5 from 'very slightly or not at all' to 'extremely'. The information on the menus made me feel... * Anxious about my food choice * Guilty about my food choice * Reassured about my food choice * Ashamed about my food choice * Fixated on the nutritional content of my food choice

    Day 1 of 1: Participants will complete these measures immediately after making their food choices.

  • Perceived impact of labelling on mental health

    Two additional questions relating to compensation were adapted from an existing scale related to compensatory eating behaviour and alcohol (CEBRACS). Participants will be asked to respond to each of the following points on a scale of 1 to 5 from 'very slightly or not at all' to 'extremely'. * Like I should eat less than usual during one or more meals to make up for the amount of food I have selected * Like I should skip one or more meals to make up for the amount of food I have selected

    Day 1 of 1: Participants will complete this measure immediately after making their food choices

Secondary Outcomes (2)

  • Nutri-Score labels of selected food items

    Day 1 of 1: UK Nutrient Profiling Model scores of food orders will be recorded immediately after the baseline questionnaire.

  • Energy content of meals

    Day 1 of 1: energy content of food orders will be recorded immediately after the baseline questionnaire.

Other Outcomes (8)

  • Participant education

    Day 1 of 1: Participants will report demographic data in a baseline questionnaire prior to completing the food selection task Participants will be asked this question in the follow-up survey as an consistency check after the food selection task

  • Notice and impact of labels

    Day 1 of 1: Participants will be asked these questions immediately after the food selection task

  • Participant age

    Day 1 of 1: Participants will report demographic data in a baseline questionnaire prior to completing the food selection task

  • +5 more other outcomes

Study Arms (3)

Control group

OTHER

Participants with no diagnosis of a mental health or eating disorder

Behavioral: Control conditionBehavioral: Calorie labellingBehavioral: Nutri-Score labelling

Mental health diagnosis group

EXPERIMENTAL

Participants with a diagnosis of a mental health condition but no diagnosis of an eating disorder

Behavioral: Control conditionBehavioral: Calorie labellingBehavioral: Nutri-Score labelling

Eating disorder diagnosis group

EXPERIMENTAL

Participants with a diagnosis of an eating disorder

Behavioral: Control conditionBehavioral: Calorie labellingBehavioral: Nutri-Score labelling

Interventions

Participants will be asked to select a meal from a food menu with no nutritional labelling

Control groupEating disorder diagnosis groupMental health diagnosis group

Participants will be asked to select a meal from a food menu with calorie labelling

Control groupEating disorder diagnosis groupMental health diagnosis group

Participants will be asked to select a meal from a food menu with calorie labelling

Control groupEating disorder diagnosis groupMental health diagnosis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residing in the UK
  • 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
  • Can complete the study on a laptop or desktop computer (not touch screen)
  • Current or previous eating disorder diagnosis by a medical practitioner
  • Current or previous common mental health condition (i.e. anxiety and/or depression) diagnosis by a medical practitioner but no eating disorder diagnosis
  • No diagnosis of eating disorder or mental health condition

You may not qualify if:

  • Pregnant/breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L69 7ZA, United Kingdom

Location

MeSH Terms

Conditions

Feeding BehaviorPsychological Well-BeingFeeding and Eating DisordersObesity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorPersonal SatisfactionSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Eric Robinson, PhD

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Robinson, PhD

CONTACT

Amy Finlay, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and researchers will not know the group to which individuals have been assigned
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2026

First Posted

September 9, 2026

Study Start

September 1, 2026

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

September 9, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Anonymised participant data will be placed in an online data repository for other researchers to use in the future.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
IPD and supporting information will be available once the study is completed and published, with no end date.
Access Criteria
The IPD and supporting information will be uploaded to an online repository where it will be openly available.

Locations