Nutrition PoorNCT04336540
Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice
A study testing Menu configuration (presence of energy labelling) and Menu configuration (more lower energy options added) in people with Nutrition Poor and Obesity, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
Two randomized control trials examining human food choice (i.e. selection of high energy 'unhealthy' foods vs. selection of healthier foods). Interventions: In a between-subjects design, participants (recruitment stratified by socioeconomic position) made food choices (main dish, plus optional sides and desserts) in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Poor, Obesity, Diet, Healthy
- What is being tested?
- Menu configuration (presence of energy labelling) and Menu configuration (more lower energy options added)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,091 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants were eligible to participate if they were US residents, aged of 18 or above, fluent in English, had access to a computer with an internet connection and had no dietary restrictions
Who cannot join
- See above.
- Stratification Criteria:
- We aimed to recruit a sample stratified by gender (approx. 50/50) and highest educational qualification (approx. 40% high school or less, 60% above high school) to be broadly representative of US adults.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 7ZA
About this study
Official title: Socioeconomic Position and the Impact of Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice in Virtual Full-service Restaurants: Two Randomized Control Trials
Two randomized control trials examining human food choice (i.e. selection of high energy 'unhealthy' foods vs. selection of healthier foods). Interventions: In a between-subjects design, participants (recruitment stratified by socioeconomic position) made food choices (main dish, plus optional sides and desserts) in the absence vs. presence of menu energy labelling and from menus with baseline (10%) vs. increased availability (50%) of lower energy main dishes. Main outcome measures: Average energy content (kcal) of main dish chosen and average total energy content of all food ordered, including optional sides and desserts.
Read the detailed description
See attached protocol documents.
- Conditions
- Nutrition Poor, Obesity, Diet, Healthy, Food Selection
- Being tested
- Menu configuration (presence of energy labelling), Menu configuration (more lower energy options added)
- Medical subject headings
- Malnutrition, Obesity, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menu configuration (presence of energy labelling)Other
Restaurant menus are altered to accommodate energy labelling intervention
Menu configuration (more lower energy options added)Other
Restaurant menus are altered to include more lower energy options
| Study group | Role | What they receive |
|---|---|---|
| Energy labelling | Experimental | Energy labelling provided on restaurant menus Receives: Other: Menu configuration (presence of energy labelling) |
| No energy labelling | No intervention | No energy labelling provided on restaurant menus |
| Increased availability of lower energy meals | Experimental | Higher proportion of meals are 600kcals or less Receives: Other: Menu configuration (presence of energy labelling); Other: Menu configuration (more lower energy options added) |
| Baseline availability of lower energy meals | No intervention | Proportion of meals that are 600kcals or less at baseline level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy ordered from main menu
Total kcal content of main menu order
Measured: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
Secondary outcomes (1)
Total energy ordered
Total kcal content of all food ordered (including sides, desserts)
Measured: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Aug 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition PoorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Robinson, University of Liverpool
- Investigators
- Eric Robinson, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336540
- Sponsor's protocol ID
- 803194 1B2
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared on the Open Science Framework
Publications
Marty L, Reed SM, Jones AJ, Robinson E. Increasing availability of lower energy meals vs. energy labelling in virtual full-service restaurants: two randomized controlled trials in participants of higher and lower socioeconomic position. BMC Public Health. 2021 May 25;21(1):975. doi: 10.1186/s12889-021-11007-0.
PubMed 34034699
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Position and the Impact of Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice in Virtual Full-service Restaurants: Two Randomized Control Trials
- ClinicalTrials.gov ID
- NCT04336540
- Acronym / sponsor ID
- 803194 1B2
- Conditions
- Nutrition Poor, Obesity, Diet, Healthy, Food Selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,091 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two randomized control trials examining human food choice (i.e. selection of high energy 'unhealthy' foods vs. selection of healthier foods). Interventions: In a between-subjects design, participants (recruitment stratified by socioeconomic position) made food choices (main dish, plus optional sides and desserts) in the absence vs. presence of menu energy labelling and from menus with baseline (10%) vs. increased availability (50%) of lower energy main dishes. Main outcome measures: Average energy content (kcal) of main dish chosen and average total energy content of all food ordered, including optional sides and desserts.
Detailed description
See attached protocol documents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Energy labelling | Experimental | Other: Menu configuration (presence of energy labelling)Energy labelling provided on restaurant menus |
| No energy labelling | No intervention | –No energy labelling provided on restaurant menus |
| Increased availability of lower energy meals | Experimental | Other: Menu configuration (presence of energy labelling), Other: Menu configuration (more lower energy options added)Higher proportion of meals are 600kcals or less |
| Baseline availability of lower energy meals | No intervention | –Proportion of meals that are 600kcals or less at baseline level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants were eligible to participate if they were US residents, aged of 18 or above, fluent in English, had access to a computer with an internet connection and had no dietary restrictions
Key exclusion criteria (3 listed)
- See above.
- We aimed to recruit a sample stratified by gender (approx. 50/50) and highest educational qualification (approx. 40% high school or less, 60% above high school) to be broadly representative of US adults.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menu configuration (presence of energy labelling)Restaurant menus are altered to accommodate energy labelling intervention | Other | Energy labelling, Increased availability of lower energy meals |
| Menu configuration (more lower energy options added)Restaurant menus are altered to include more lower energy options | Other | Increased availability of lower energy meals |
Primary outcome
Energy ordered from main menu
Time frame: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
Total kcal content of main menu order
1 secondary outcome
Total energy ordered
Time frame: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 34034699Marty L, Reed SM, Jones AJ, Robinson E. Increasing availability of lower energy meals vs. energy labelling in virtual full-service restaurants: two randomized controlled trials in participants of higher and lower socioeconomic position. BMC Public Health. 2021 May 25;21(1):975. doi: 10.1186/s12889-021-11007-0.
- Individual participant dataSharing planned: Yes. Shared on the Open Science Framework
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Robinson, PhD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menu configuration (presence of energy labelling) and Menu configuration (more lower energy options added) in people with Nutrition Poor and Obesity, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy ordered from main menu (time frame: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.