Food SelectionNCT06263621
Changing Portion Size Descriptions in a Cafeteria
A study testing Intervention "Standard" in people with Food Selection and Obesity, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard"… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Food Selection, Obesity, Weight Gain
- What is being tested?
- Intervention "Standard"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101,481 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jan 2024to 29 May 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All customers who make a lunch purchase at the cafes
Who cannot join
- Purchases made outside of lunch service.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Courtyard Cafe
Boston, Massachusetts, 02115
Elements Cafe
Boston, Massachusetts, 02115
About this study
Official title: Changing Restaurant Portion Size Descriptions to Encourage Selection and Intake of Smaller Meals: a Field Experiment
The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?
Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences.
Read the detailed description
The investigators will work with two cafés that will start offering two size options for their entrées. The cafés will go through three phases: a baseline phase where there are two portion sizes and no intervention (6 weeks), an intervention phase where the portion size labeling strategy will be implemented (7 weeks), and then a final phase where the portion size intervention is removed (7 weeks). During the baseline period, the smaller-sized entrée will not receive a label, and the larger-sized entrée will be called "Large." During the intervention period for the control café, labeling will stay the same, but in the intervention café, the smaller size will be labeled "Standard" and the larger size will be called "Large." In the post-intervention period, the smaller-sized entrée in the intervention café will have no label so that it resembles the control café.
- Conditions
- Food Selection, Obesity, Weight Gain, Food Preferences
- Being tested
- Intervention "Standard"
- Keywords
- portion size, choice behavior, energy intake, food labeling
- Medical subject headings
- Food Preferences, Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention "Standard"Behavioural
Also called "Standard"
The two cafes will offer entrees in two sizes, a smaller and larger size. In the intervention cafe, the smaller size will be labeled "Standard" during the intervention period, and "Small" during all other times. In the control cafe, the smaller size will always be labeled "Small." The larger size will always be labeled "Large" for both cafes during the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention "Standard" | Experimental | The smaller entree is labeled "Standard" and the larger entree is labeled "Large." Receives: Behavioral: Intervention "Standard" |
| Control "Small" | No intervention | The smaller entree is labeled "Small" and the larger entree is labeled "Large." |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average kcal per entree sold
The primary outcome will be the average kcal per entrée purchased.
Measured: Daily sales data for 5.5 months
Secondary outcomes (3)
Number of entrée units purchased
Analyzing the number of entrée units purchased will enable the investigators to assess the impact of the intervention on entree sales.
Measured: Daily sales data for 5.5 months
Total kcal per transaction
This will allow the investigators to examine whether participants who ordered a reduced-sized entrée were ordering more calories in other parts of the meal (i.e., a dessert).
Measured: Daily sales data for 5.5 months
Weekly gross sales
This will allow the investigators to assess whether the addition of a reduced-sized entrée at a lower cost negatively affected lunch service revenue.
Measured: Daily sales data for 5.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start11 Jan 2024
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Entrees are offered in two different portion sizes at two cafes. The cafes were randomized to either receive the "Standard" portion label for the smaller size (Intervention) or the "Small" portion label for the smaller size (Control). The larger portion was labeled "Large." Daily lunch transaction data will be provided by the cafes.
- Masking
- None (open label)
- Enrolment
- 101,481 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Restaurant Associates
- Responsible party
- Principal investigator, Sophia Hua, University of Pennsylvania
- Investigators
- Sophia V Hua, PhD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263621
- Sponsor's protocol ID
- 855090
- Status last verified
- Jul 2024
- First submitted
- 8 Feb 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sales data will be made available to interested researchers pending approval from cafe managers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Restaurant Portion Size Descriptions to Encourage Selection and Intake of Smaller Meals: a Field Experiment
- ClinicalTrials.gov ID
- NCT06263621
- Acronym / sponsor ID
- 855090
- Conditions
- Food Selection, Obesity, Weight Gain, Food Preferences
- Keywords
- portion size, choice behavior, energy intake, food labeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101,481 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Restaurant Associates
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 16 Feb 2024 (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.
The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?
Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences.
Detailed description
The investigators will work with two cafés that will start offering two size options for their entrées. The cafés will go through three phases: a baseline phase where there are two portion sizes and no intervention (6 weeks), an intervention phase where the portion size labeling strategy will be implemented (7 weeks), and then a final phase where the portion size intervention is removed (7 weeks). During the baseline period, the smaller-sized entrée will not receive a label, and the larger-sized entrée will be called "Large." During the intervention period for the control café, labeling will stay the same, but in the intervention café, the smaller size will be labeled "Standard" and the larger size will be called "Large." In the post-intervention period, the smaller-sized entrée in the intervention café will have no label so that it resembles the control café.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Entrees are offered in two different portion sizes at two cafes. The cafes were randomized to either receive the "Standard" portion label for the smaller size (Intervention) or the "Small" portion label for the smaller size (Control). The larger portion was labeled "Large." Daily lunch transaction data will be provided by the cafes.
| Arm | Type | Receives |
|---|---|---|
| Intervention "Standard" | Experimental | Behavioral: Intervention "Standard"The smaller entree is labeled "Standard" and the larger entree is labeled "Large." |
| Control "Small" | No intervention | –The smaller entree is labeled "Small" and the larger entree is labeled "Large." |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All customers who make a lunch purchase at the cafes
Key exclusion criteria (1 listed)
- Purchases made outside of lunch service.
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 |
|---|---|---|
| Intervention "Standard"Also: "Standard"The two cafes will offer entrees in two sizes, a smaller and larger size. In the intervention cafe, the smaller size will be labeled "Standard" during the intervention period, and "Small" during all other times. In the control cafe, the smaller size will always be labeled "Small." The larger size will always be labeled "Large" for both cafes during the duration of the study. | Behavioural | Intervention "Standard" |
Primary outcome
Average kcal per entree sold
Time frame: Daily sales data for 5.5 months
The primary outcome will be the average kcal per entrée purchased.
3 secondary outcomes
Number of entrée units purchased
Time frame: Daily sales data for 5.5 months
Total kcal per transaction
Time frame: Daily sales data for 5.5 months
Weekly gross sales
Time frame: Daily sales data for 5.5 months
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 11 Jul 2024.
- Individual participant dataSharing planned: Undecided. Sales data will be made available to interested researchers pending approval from cafe managers.
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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.
Sophia V Hua, PhD, MPH principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention "Standard" in people with Food Selection and Obesity, run by University of Pennsylvania at 2 sites in United States.
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 1 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 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Average kcal per entree sold (time frame: Daily sales data for 5.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2024.