- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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)
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Eric Robinson, PhD
- Numer telefonu: 1187 +44 151794
- E-mail: robinsoe@liverpool.ac.uk
Kopia zapasowa kontaktu do badania
- Nazwa: Amy Finlay, PhD
- E-mail: amy.finlay@liverpool.ac.uk
Lokalizacje studiów
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Merseyside
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Liverpool, Merseyside, Zjednoczone Królestwo, L69 7ZA
- University of Liverpool
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Kontakt:
- Eric Robinson, PhD
- Numer telefonu: 1187 +44 151794
- E-mail: robinsoe@liverpool.ac.uk
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Inny: 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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Eksperymentalny: 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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Eksperymentalny: 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
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Perceived Message Effectiveness
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Nutri-Score labels of selected food items
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Participant education
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Eric Robinson, PhD, University of Liverpool
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zaburzenia odżywiania
- Przekarmienie
- Masy ciała
- Oznaki i objawy, układ pokarmowy
- Nadwaga
- Stany patologiczne, oznaki i objawy
- Zachowanie
- Choroby żywieniowe i metaboliczne
- Objawy i symptomy
- Satysfakcja osobista
- Zachowanie, zwierzę
- Otyłość
- Zaburzenia odżywiania i odżywiania
- Samopoczucie psychiczne
- Zachowanie żywieniowe
Inne numery identyfikacyjne badania
- Nutri-Score and mental health
- NIHR203316 (Inny numer grantu/finansowania: NIHR Oxford Health Biomedical Research Centre)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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