- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07809295
Food Menu Labelling Effects on Individuals With Eating Disorders and Other Mental Health Conditions.
Exploration of Nutri-Score Labelling Out-of-home on Individuals With Eating Disorders and Other Mental Health Diagnoses.
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)
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Eric Robinson, PhD
- Telefonszám: 1187 +44 151794
- E-mail: robinsoe@liverpool.ac.uk
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Amy Finlay, PhD
- E-mail: amy.finlay@liverpool.ac.uk
Tanulmányi helyek
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Merseyside
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Liverpool, Merseyside, Egyesült Királyság, L69 7ZA
- University of Liverpool
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Kapcsolatba lépni:
- Eric Robinson, PhD
- Telefonszám: 1187 +44 151794
- E-mail: robinsoe@liverpool.ac.uk
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-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- 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)
Inclusion for specific participant groups:
- 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
Exclusion Criteria:
- Pregnant/breastfeeding
- Have taken part in a previous study using the same version of the online food choice task (exclusion list obtained from prolific)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Egyéb: Control group
Participants with no diagnosis of a mental health or eating disorder
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Participants will be asked to select a meal from a food menu with no nutritional labelling
Participants will be asked to select a meal from a food menu with calorie labelling
Participants will be asked to select a meal from a food menu with calorie labelling
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Kísérleti: Mental health diagnosis group
Participants with a diagnosis of a mental health condition but no diagnosis of an eating disorder
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Participants will be asked to select a meal from a food menu with no nutritional labelling
Participants will be asked to select a meal from a food menu with calorie labelling
Participants will be asked to select a meal from a food menu with calorie labelling
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Kísérleti: Eating disorder diagnosis group
Participants with a diagnosis of an eating disorder
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Participants will be asked to select a meal from a food menu with no nutritional labelling
Participants will be asked to select a meal from a food menu with calorie labelling
Participants will be asked to select a meal from a food menu with calorie labelling
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Perceived Message Effectiveness
Időkeret: Day 1 of 1: the PME measure will be completed immediately after participants have made their food selection
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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.
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Day 1 of 1: the PME measure will be completed immediately after participants have made their food selection
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Perceived usefulness of menu in identifying healthier/less healthy food choices
Időkeret: Day 1 of 1: Participants will rate the perceived usefulness of the menu immediately after making their food selection.
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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".
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Day 1 of 1: Participants will rate the perceived usefulness of the menu immediately after making their food selection.
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Nutritional quality of food ordered
Időkeret: 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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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.
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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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Positive/negative affect
Időkeret: Day 1 of 1: Participants will complete the PANAS measure immediately after making their food selection
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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.
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Day 1 of 1: Participants will complete the PANAS measure immediately after making their food selection
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Perceived impact of labelling on mental health
Időkeret: Day 1 of 1: Participants will complete these measures immediately after making their food choices.
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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...
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Day 1 of 1: Participants will complete these measures immediately after making their food choices.
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Perceived impact of labelling on mental health
Időkeret: Day 1 of 1: Participants will complete this measure immediately after making their food choices
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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'.
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Day 1 of 1: Participants will complete this measure immediately after making their food choices
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Nutri-Score labels of selected food items
Időkeret: Day 1 of 1: UK Nutrient Profiling Model scores of food orders will be recorded immediately after the baseline questionnaire.
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We will record the Nutri-Score values (A-E) of all items selected by participants in the food choice task.
Participants will be coded as having ordered any of the healthiest menu items labelled A or B (Y/N) and/or the least healthy menu items labelled D or E (Y/N).
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Day 1 of 1: UK Nutrient Profiling Model scores of food orders will be recorded immediately after the baseline questionnaire.
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Energy content of meals
Időkeret: Day 1 of 1: energy content of food orders will be recorded immediately after the baseline questionnaire.
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We will record the energy and nutrient content of all items selected by participants in the food choice task.
The total energy content of the ordered meal will be calculated.
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Day 1 of 1: energy content of food orders will be recorded immediately after the baseline questionnaire.
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Participant education
Időkeret: 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
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Participants will be asked to report their highest level of education achieved:
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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
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Notice and impact of labels
Időkeret: Day 1 of 1: Participants will be asked these questions immediately after the food selection task
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Participants will be asked several questions to assess whether they noticed any nutritional labelling, and if the labelling impacted their food choices.
Questions will be amended slightly according to labelling condition.
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Day 1 of 1: Participants will be asked these questions immediately after the food selection task
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Participant age
Időkeret: Day 1 of 1: Participants will report demographic data in a baseline questionnaire prior to completing the food selection task
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Participants will report their age on a dropdown list
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Day 1 of 1: Participants will report demographic data in a baseline questionnaire prior to completing the food selection task
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Participant gender
Időkeret: Day 1 of 1: Participants will report demographic data in a baseline questionnaire prior to completing the food selection task
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Participants will select their gender from the following options:
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Day 1 of 1: Participants will report demographic data in a baseline questionnaire prior to completing the food selection task
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Participant ethnicity
Időkeret: Day 1 of 1: Participants will report demographic data in a baseline questionnaire prior to completing the food selection task
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Participants will select their ethnicity from a dropdown list: White English/Welsh/Scottish/Northern Irish/British White Irish Any other White background White and Black Caribbean White and Black African Any other mixed/multiple ethnic background please describe Indian Pakistani Bangladeshi Chinese Other Asian African Caribbean Arab Any other ethnic group |
Day 1 of 1: Participants will report demographic data in a baseline questionnaire prior to completing the food selection task
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Participant height
Időkeret: Day 1 of 1: Participants will be asked these questions immediately after the food selection task
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Participants will report their height in either cm or ft and inches.
This will be converted to metres in order to calculate BMI.
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Day 1 of 1: Participants will be asked these questions immediately after the food selection task
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Participant weight
Időkeret: Day 1 of 1: Participants will be asked these questions immediately after the food selection task
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Participants will report their weight in either kg or stones and pounds.
All will be converted if necessary to KG to calculate BMI.
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Day 1 of 1: Participants will be asked these questions immediately after the food selection task
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Frequency of consumption of OOH food
Időkeret: Day 1 of 1: Participants will report this in a baseline questionnaire prior to completing the food selection task
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Participants will be asked how often over the past year they have eaten food prepared out of the home (from restaurants, cafes, fast food etc.). The following options will be listed.
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Day 1 of 1: Participants will report this in a baseline questionnaire prior to completing the food selection task
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Eric Robinson, PhD, University of Liverpool
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Mentális zavarok
- Táplálkozási zavarok
- Túltáplálás
- Testsúly
- Jelek és tünetek, emésztés
- Túlsúly
- Kóros állapotok, jelek és tünetek
- Viselkedés
- Táplálkozási és anyagcsere-betegségek
- Jelek és tünetek
- Személyes elégedettség
- Viselkedés, állat
- Elhízottság
- Táplálkozási és étkezési zavarok
- Pszichológiai jólét
- Táplálkozási viselkedés
Egyéb vizsgálati azonosító számok
- Nutri-Score and mental health
- NIHR203316 (Egyéb támogatási/finanszírozási szám: NIHR Oxford Health Biomedical Research Centre)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
- ANALYTIC_CODE
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