Food SelectionNCT02804503
The Effect of Menu Labels on Calories Ordered in Hispanics
A study testing Calorie Labels, Exercise Labels and No Labels in people with Food Selection, run by Texas Christian University at 1 site in United States.
Trial summary
Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and how menu labels affect calories and macronutrients ordered in Hispanics is not clearly understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Selection
- What is being tested?
- Calorie Labels, Exercise Labels and No Labels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hispanics ages 18 through 65 years.
Who cannot join
- Not being able to read and write in either English or Spanish; pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Menu Labels on Food Choices in Hispanics
Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and how menu labels affect calories and macronutrients ordered in Hispanics is not clearly understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics.
Read the detailed description
According to review studies, calorie labels on menus is not effective in reducing the number of calories ordered or consumed. Adding contextual information such as the energy needs per meal or interpretive information such as minutes of walking needed to burn the food calories or rank-ordering the food items from the lowest to the highest calorie content may be more effective in making food selections with fewer calories. Most studies on menu labels have, however, been conducted in mostly non-Hispanic white individuals, and how menu labels affect food choices in Hispanics in not well understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics by randomly assigning the participants to a menu with no labels (no labels), a menu with rank ordered calorie labels and a statement on the energy needs per meal (calorie labels), and a menu with rank ordered exercise labels (exercise labels). Calories and macronutrients ordered by the participants was assessed.
- Conditions
- Food Selection
- Being tested
- Calorie Labels, Exercise Labels, No Labels
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie LabelsBehavioural
Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.
Exercise LabelsBehavioural
Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.
No LabelsBehavioural
Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.
| Study group | Role | What they receive |
|---|---|---|
| Calorie Labels | Experimental | A menu with rank ordered calorie labels and a statement on the energy needs per meal. Receives: Behavioral: Calorie Labels |
| Exercise Labels | Experimental | A menu with rank ordered exercise labels showing minutes of brisk walking necessary to burn the food calories. Receives: Behavioral: Exercise Labels |
| No Labels | Active comparator | A menu with no labels Receives: Behavioral: No Labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories Ordered
Calories content of the food items ordered from the assigned menu was calculated.
Measured: 20-30 minutes
Secondary outcomes (1)
Macronutrients ordered
Macronutrients content of the food items ordered from the assigned menu was calculated.
Measured: 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Food SelectionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meena Shah, Texas Christian University
- Investigators
- Meena Shah, Ph.D., Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804503
- Sponsor's protocol ID
- CT2016MS1
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Long MW, Tobias DK, Cradock AL, Batchelder H, Gortmaker SL. Systematic review and meta-analysis of the impact of restaurant menu calorie labeling. Am J Public Health. 2015 May;105(5):e11-24. doi: 10.2105/AJPH.2015.302570. Epub 2015 Mar 19.
PubMed 25790388Swartz JJ, Braxton D, Viera AJ. Calorie menu labeling on quick-service restaurant menus: an updated systematic review of the literature. Int J Behav Nutr Phys Act. 2011 Dec 8;8:135. doi: 10.1186/1479-5868-8-135.
PubMed 22152038Sinclair SE, Cooper M, Mansfield ED. The influence of menu labeling on calories selected or consumed: a systematic review and meta-analysis. J Acad Nutr Diet. 2014 Sep;114(9):1375-1388.e15. doi: 10.1016/j.jand.2014.05.014. Epub 2014 Jul 16.
PubMed 25037558Shah M, Bouza B, Adams-Huet B, Jaffery M, Esposito P, Dart L. Effect of calorie or exercise labels on menus on calories and macronutrients ordered and calories from specific foods in Hispanic participants: a randomized study. J Investig Med. 2016 Dec;64(8):1261-1268. doi: 10.1136/jim-2016-000227. Epub 2016 Jul 8.
PubMed 27402619
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menu Labels on Food Choices in Hispanics
- ClinicalTrials.gov ID
- NCT02804503
- Acronym / sponsor ID
- CT2016MS1
- Conditions
- Food Selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and how menu labels affect calories and macronutrients ordered in Hispanics is not clearly understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics.
Detailed description
According to review studies, calorie labels on menus is not effective in reducing the number of calories ordered or consumed. Adding contextual information such as the energy needs per meal or interpretive information such as minutes of walking needed to burn the food calories or rank-ordering the food items from the lowest to the highest calorie content may be more effective in making food selections with fewer calories. Most studies on menu labels have, however, been conducted in mostly non-Hispanic white individuals, and how menu labels affect food choices in Hispanics in not well understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics by randomly assigning the participants to a menu with no labels (no labels), a menu with rank ordered calorie labels and a statement on the energy needs per meal (calorie labels), and a menu with rank ordered exercise labels (exercise labels). Calories and macronutrients ordered by the participants was assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calorie Labels | Experimental | Behavioral: Calorie LabelsA menu with rank ordered calorie labels and a statement on the energy needs per meal. |
| Exercise Labels | Experimental | Behavioral: Exercise LabelsA menu with rank ordered exercise labels showing minutes of brisk walking necessary to burn the food calories. |
| No Labels | Active comparator | Behavioral: No LabelsA menu with no labels |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hispanics ages 18 through 65 years.
Key exclusion criteria (1 listed)
- Not being able to read and write in either English or Spanish; pregnant or lactating women.
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 |
|---|---|---|
| Calorie LabelsParticipants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant. | Behavioural | Calorie Labels |
| Exercise LabelsParticipants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant. | Behavioural | Exercise Labels |
| No LabelsParticipants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant. | Behavioural | No Labels |
Primary outcome
Calories Ordered
Time frame: 20-30 minutes
Calories content of the food items ordered from the assigned menu was calculated.
1 secondary outcome
Macronutrients ordered
Time frame: 20-30 minutes
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 17 Jun 2016.
- Background: PubMed 25790388Long MW, Tobias DK, Cradock AL, Batchelder H, Gortmaker SL. Systematic review and meta-analysis of the impact of restaurant menu calorie labeling. Am J Public Health. 2015 May;105(5):e11-24. doi: 10.2105/AJPH.2015.302570. Epub 2015 Mar 19.
- Results publication: PubMed 22152038Swartz JJ, Braxton D, Viera AJ. Calorie menu labeling on quick-service restaurant menus: an updated systematic review of the literature. Int J Behav Nutr Phys Act. 2011 Dec 8;8:135. doi: 10.1186/1479-5868-8-135.
- Results publication: PubMed 25037558Sinclair SE, Cooper M, Mansfield ED. The influence of menu labeling on calories selected or consumed: a systematic review and meta-analysis. J Acad Nutr Diet. 2014 Sep;114(9):1375-1388.e15. doi: 10.1016/j.jand.2014.05.014. Epub 2014 Jul 16.
- Derived from this study: PubMed 27402619Shah M, Bouza B, Adams-Huet B, Jaffery M, Esposito P, Dart L. Effect of calorie or exercise labels on menus on calories and macronutrients ordered and calories from specific foods in Hispanic participants: a randomized study. J Investig Med. 2016 Dec;64(8):1261-1268. doi: 10.1136/jim-2016-000227. Epub 2016 Jul 8.
- Individual participant dataSharing planned: No
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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.
Meena Shah, Ph.D. principal investigator
Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie Labels, Exercise Labels and No Labels in people with Food Selection, run by Texas Christian University at 1 site 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 17 Jun 2016. 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 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?
Calories Ordered (time frame: 20-30 minutes). 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 NCT02804503, which also lists 4 linked publications.
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 17 Jun 2016.