Food PreferencesNCT03337633

Effects of Restaurant Menu Design on Food Ordering Outcomes

A study testing Menu design in people with Food Preferences, run by University of Alabama at Birmingham.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

High cognitive load activities can influence energy intake from food. It is unknown how restaurant menu designs may affect patrons in terms of cognitive demand and subsequent ordering of food.Objective: Our objective was to develop and experimentally test menu designs that differ in cognitive load to test the… Read more about this study

Who is it for?: Ages 19 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Food Preferences
What is being tested?: Menu design
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: No sites listed yet
Study dates: 1 Apr 2014to 20 Mar 2015
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 19 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Normal vision or corrective lenses
Normal hearing or a hearing aid
A moderate level of English proficiency or greater
Free from current food restrictions
Normal vision or corrective lenses
Normal hearing or a hearing aid

Show all 9Show fewer

A moderate level of English proficiency or greater
Free from current food restrictions
Qualifying as a restrained eater by the Cognitive Restraint scale on the Eating Inventory (score of 6 for men and 10 for women)

Who cannot join

Unwilling/uninterested in participation
Currently taking any β-blocker medications
Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)
Experiment 2
Unwilling/uninterested in participation
Currently taking any β-blocker medications
Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)

About this study

Official title: Effects of Menu Design on Psychophysiological Measures of Cognitive Load and Food Ordering Outcomes

Read the detailed description

For the first experiment, a parallel randomized trial of healthy young adults (n= 30) was conducted to compare ordering from one of two menu designs (easy - E, hard - H) developed in a prior pilot study. In the second experiment, restrained eaters were specifically recruited and asked to fast before the experiment to determine the influence of cognitive load of menus on energy ordered (n=31). Galvanic skin response was used as an objective proxy for relative cognitive load, and questionnaires were used to assess perceptions of the menus. The main outcomes were the number of items ordered and total energy of the items ordered (in kilocalories).

Conditions: Food Preferences
Being tested: Menu design
Keywords: cognitive load, galvanic skin response, meal size, kilocalories, menu design
Medical subject headings: Food Preferences

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Menu designBehavioural
Participants were given 5 minutes to order a hypothetical meal from the assigned test menu by circling all items they wanted to order.

Study groups in NCT03337633
Study group	Role	What they receive
Experiment 1 Easy	Active comparator	For the first experiment, subjects in this arm received the "easy" menu during the protocol. Receives: Behavioral: Menu design
Experiment 1 Hard	Active comparator	For the first experiment, subjects in this arm received the "hard" menu during the protocol. Receives: Behavioral: Menu design
Experiment 2 Easy	Active comparator	For the second experiment, subjects in this arm, who qualified as restrained eaters and were asked to fast for 8 hours overnight, received the "easy" menu during the protocol. Receives: Behavioral: Menu design
Experiment 2 Hard	Active comparator	For the second experiment, subjects in this arm, who qualified as restrained eaters and were asked to fast for 8 hours overnight, received the "hard" menu during the protocol. Receives: Behavioral: Menu design

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Number of Items Ordered
Total number of items ordered off assigned menu
Measured: During the 5-minute menu ordering task
Total Energy of Items ordered
Total Energy (kcals) of items ordered off assigned menu
Measured: During the 5-minute menu ordering task

Secondary outcomes (2)

Subjective ratings of difficulty of using assigned menu to order a meal
Assessed by NASA Task Load Index questionnaire
Measured: Immediately (1 minute) following the 5-minute menu ordering period
Galvanic Skin Response
An objective proxy for relative cognitive load; this measure has been shown to be positively correlated with psychological stress or cognitive challenge as mediated by sympathetic nervous system activity
Measured: During the 5-minute menu ordering task

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201420 Mar 2015

First posted9 Nov 2017
Study start1 Apr 2014
Primary completion20 Mar 2015
Study completion20 Mar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Food PreferencesStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel arm randomized controlled trial
Masking: Single blind
Who is masked: Participant
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03337633
Sponsor's protocol ID: X140313004
Status last verified: Nov 2017
First submitted: 18 Oct 2017
Last updated: 9 Nov 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Pending approval by the University of Alabama at Birmingham's Institutional Review Board (IRB), which we have received for other studies and anticipate receiving here, we will prepare transportable de-identified raw databases and codebooks, which will contain the raw data used in any paper we publish from the proposed research. We will publically deposit such raw data for access by others without restriction in a public repository such as ICPSR. For any investigator requesting data we have not yet published, we will be glad to provide de-identified data and codebooks to the investigators provided that the proposed use does not conflict with our intentions for use.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Influence of Social Media Ads on Food Choice - Master Protocol
Food Selection, Food Choices
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The Florida ASCENT Study
Cancer, Food Deprivation
Recruiting
Using Single and Combined Nudge Strategies to Promote Healthier Beverage Intake Among College Students
Obesity, Food Selection
Recruiting
Influence of "Likes" in Social Media Food Ads on Black and White Adolescents' Food Purchases - Study 2
Food Selection
RecruitingObservational study
Evolution of Food Oral Processing Behaviours, Food Bolus Formation and Texture Preferences Between 6 to 12 Years Old and Adult Age
Food Oral Processing, Texture Preference

All Food Preferences trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Menu Design on Psychophysiological Measures of Cognitive Load and Food Ordering Outcomes
ClinicalTrials.gov ID: NCT03337633
Acronym / sponsor ID: X140313004
Conditions: Food Preferences
Keywords: cognitive load, galvanic skin response, meal size, kilocalories, menu design
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: Texas Tech University
Study start: 1 Apr 2014 (actual)
Primary completion: 20 Mar 2015 (actual)
Study completion: 20 Mar 2015 (actual)
First posted: 9 Nov 2017 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: Parallel arm randomized controlled trial

Arm	Type	Receives
Experiment 1 Easy	Active comparator	Behavioral: Menu designFor the first experiment, subjects in this arm received the "easy" menu during the protocol.
Experiment 1 Hard	Active comparator	Behavioral: Menu designFor the first experiment, subjects in this arm received the "hard" menu during the protocol.
Experiment 2 Easy	Active comparator	Behavioral: Menu designFor the second experiment, subjects in this arm, who qualified as restrained eaters and were asked to fast for 8 hours overnight, received the "easy" menu during the protocol.
Experiment 2 Hard	Active comparator	Behavioral: Menu designFor the second experiment, subjects in this arm, who qualified as restrained eaters and were asked to fast for 8 hours overnight, received the "hard" menu during the protocol.

Who may qualify

Ages: 19 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Normal vision or corrective lenses
Normal hearing or a hearing aid
A moderate level of English proficiency or greater
Free from current food restrictions
Normal vision or corrective lenses

Key exclusion criteria (7 listed)

Unwilling/uninterested in participation
Currently taking any β-blocker medications
Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)
Experiment 2
Unwilling/uninterested in participation

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 designParticipants were given 5 minutes to order a hypothetical meal from the assigned test menu by circling all items they wanted to order.	Behavioural	Experiment 1 Easy, Experiment 1 Hard, Experiment 2 Easy, Experiment 2 Hard

Primary outcome

Total Number of Items Ordered
Time frame: During the 5-minute menu ordering task
Total number of items ordered off assigned menu
Total Energy of Items ordered
Time frame: During the 5-minute menu ordering task
Total Energy (kcals) of items ordered off assigned menu

2 secondary outcomes

Subjective ratings of difficulty of using assigned menu to order a meal
Time frame: Immediately (1 minute) following the 5-minute menu ordering period
Galvanic Skin Response
Time frame: During the 5-minute menu ordering task

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 9 Nov 2017.
Individual participant dataSharing planned: Yes. Pending approval by the University of Alabama at Birmingham's Institutional Review Board (IRB), which we have received for other studies and anticipate receiving here, we will prepare transportable de-identified raw databases and codebooks, which will contain the raw data used in any paper we publish from the proposed research. We will publically deposit such raw data for access by others without restriction in a public repository such as ICPSR. For any investigator requesting data we have not yet published, we will be glad to provide de-identified data and codebooks to the investigators provided that the proposed use does not conflict with our intentions for use.

Related trials for Food Preferences

Recruiting
Influence of Social Media Ads on Food Choice - Master Protocol
Food Selection, Food Choices
Recruiting
The Florida ASCENT Study
Cancer, Food Deprivation
Recruiting
Using Single and Combined Nudge Strategies to Promote Healthier Beverage Intake Among College Students
Obesity, Food Selection
Recruiting
Influence of "Likes" in Social Media Food Ads on Black and White Adolescents' Food Purchases - Study 2
Food Selection
RecruitingObservational study
Evolution of Food Oral Processing Behaviours, Food Bolus Formation and Texture Preferences Between 6 to 12 Years Old and Adult Age
Food Oral Processing, Texture Preference

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.

Kathryn A Kaiser, PhD principal investigator

University of Alabama at Birmingham, Asst. Professor, Dept of Health Behavior

Questions about this trial

What is this clinical trial studying?

A study testing Menu design in people with Food Preferences, run by University of Alabama at Birmingham.

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 9 inclusion and 7 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Total Number of Items Ordered (time frame: During the 5-minute menu ordering task). The study lists 2 primary outcomes in all. 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 NCT03337633.

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 9 Nov 2017.