HealthyNCT00127660
Effect of Nutrition Labeling on Fast Food Choices
A study testing Menu: calories=yes, value pricing=no, Menu: calories=yes, value pricing = yes and Menu: calories=no, value pricing = no in people with Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
A study examining menu choices made at fast food restaurants. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Menu: calories=yes, value pricing=no, Menu: calories=yes, value pricing = yes and Menu: calories=no, value pricing = no
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be 16 years old or older
- Must regularly eat at fast food restaurants
Who cannot join
- Non-english speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Epidemiology & Community Health, University of Minnesota
Minneapolis, Minnesota, 55454
About this study
A study examining menu choices made at fast food restaurants.
Read the detailed description
To examine the effect of point-of-purchase calorie information and value size pricing on fast food meal choices a randomized 2 × 2 factorial experiment was conducted in which participants ordered a fast food meal from one of four menus that varied with respect to whether calorie information was provided and whether value size pricing was used.
- Conditions
- Healthy
- Being tested
- Menu: calories=yes, value pricing=no, Menu: calories=yes, value pricing = yes, Menu: calories=no, value pricing = no
- Keywords
- Behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menu: calories=yes, value pricing=noBehavioural
Menu: calories=yes, value pricing = yesBehavioural
Menu: calories=no, value pricing = noBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Menu: calories=yes, value pricing=no | Experimental | There were calories listed on the menu, but no value pricing was in place. Receives: Behavioral: Menu: calories=yes, value pricing=no |
| Menu: calories=yes, value pricing = yes | Experimental | There were calories listed on the menu, AND value pricing was in place. Receives: Behavioral: Menu: calories=yes, value pricing = yes |
| Menu: calories=no, value pricing = no | Experimental | Calories were not listed on the menu, and value pricing was not in place. Receives: Behavioral: Menu: calories=no, value pricing = no |
| Menu: calories=no, value pricing = yes | No intervention | CONTROL CONDITION: calories were not listed on the menu, and value pricing WAS in place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Calories of Meal Ordered
Measured: single study visit
Energy Intake
energy content of meal ordered and consumed.
Measured: After meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa J Harnack, DrPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127660
- Sponsor's protocol ID
- DK67599 (completed)
- Other IDs
- R01DK067599
- Status last verified
- Aug 2017
- First submitted
- 4 Aug 2005
- Last updated
- 1 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Harnack LJ, French SA, Oakes JM, Story MT, Jeffery RW, Rydell SA. Effects of calorie labeling and value size pricing on fast food meal choices: results from an experimental trial. Int J Behav Nutr Phys Act. 2008 Dec 5;5:63. doi: 10.1186/1479-5868-5-63.
PubMed 19061510Fitch RC, Harnack LJ, Neumark-Sztainer DR, Story MT, French SA, Oakes JM, Rydell SA. Providing calorie information on fast-food restaurant menu boards: consumer views. Am J Health Promot. 2009 Nov-Dec;24(2):129-32. doi: 10.4278/ajhp.08031426.
PubMed 19928485Rydell SA, Harnack LJ, Oakes JM, Story M, Jeffery RW, French SA. Why eat at fast-food restaurants: reported reasons among frequent consumers. J Am Diet Assoc. 2008 Dec;108(12):2066-70. doi: 10.1016/j.jada.2008.09.008.
PubMed 19027410
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutrition Labeling on Fast Food Choices
- ClinicalTrials.gov ID
- NCT00127660
- Acronym / sponsor ID
- DK67599 (completed)
- Conditions
- Healthy
- Keywords
- Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 8 Aug 2005 (estimated)
- Results
- Posted 28 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study examining menu choices made at fast food restaurants.
Detailed description
To examine the effect of point-of-purchase calorie information and value size pricing on fast food meal choices a randomized 2 × 2 factorial experiment was conducted in which participants ordered a fast food meal from one of four menus that varied with respect to whether calorie information was provided and whether value size pricing was used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Menu: calories=yes, value pricing=no | Experimental | Behavioral: Menu: calories=yes, value pricing=noThere were calories listed on the menu, but no value pricing was in place. |
| Menu: calories=yes, value pricing = yes | Experimental | Behavioral: Menu: calories=yes, value pricing = yesThere were calories listed on the menu, AND value pricing was in place. |
| Menu: calories=no, value pricing = no | Experimental | Behavioral: Menu: calories=no, value pricing = noCalories were not listed on the menu, and value pricing was not in place. |
| Menu: calories=no, value pricing = yes | No intervention | –CONTROL CONDITION: calories were not listed on the menu, and value pricing WAS in place. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be 16 years old or older
- Must regularly eat at fast food restaurants
Key exclusion criteria (1 listed)
- Non-english speakers
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: calories=yes, value pricing=no | Behavioural | Menu: calories=yes, value pricing=no |
| Menu: calories=yes, value pricing = yes | Behavioural | Menu: calories=yes, value pricing = yes |
| Menu: calories=no, value pricing = no | Behavioural | Menu: calories=no, value pricing = no |
Primary outcome
Total Calories of Meal Ordered
Time frame: single study visit
Energy Intake
Time frame: After meal
energy content of meal ordered and consumed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19061510Harnack LJ, French SA, Oakes JM, Story MT, Jeffery RW, Rydell SA. Effects of calorie labeling and value size pricing on fast food meal choices: results from an experimental trial. Int J Behav Nutr Phys Act. 2008 Dec 5;5:63. doi: 10.1186/1479-5868-5-63.
- Results publication: PubMed 19928485Fitch RC, Harnack LJ, Neumark-Sztainer DR, Story MT, French SA, Oakes JM, Rydell SA. Providing calorie information on fast-food restaurant menu boards: consumer views. Am J Health Promot. 2009 Nov-Dec;24(2):129-32. doi: 10.4278/ajhp.08031426.
- Results publication: PubMed 19027410Rydell SA, Harnack LJ, Oakes JM, Story M, Jeffery RW, French SA. Why eat at fast-food restaurants: reported reasons among frequent consumers. J Am Diet Assoc. 2008 Dec;108(12):2066-70. doi: 10.1016/j.jada.2008.09.008.
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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.
Lisa J Harnack, DrPH principal investigator
University of Minnesota
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: calories=yes, value pricing=no, Menu: calories=yes, value pricing = yes and Menu: calories=no, value pricing = no in people with Healthy, run by University of Minnesota 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 2 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 1 Sep 2017. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Calories of Meal Ordered (time frame: single study visit). 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 NCT00127660, which also lists 3 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 1 Sep 2017.