ObesityNCT01346449
Making Calories Count: Information Format and Food Choice
A study testing Provide menu with visual cue and calorie information, Provide menu with visual cue but no calorie information and Provide menu with no visual cue but with calorie information in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study is to better understand how individuals make decisions regarding the meals they order. Participants' ordering decisions at lunchtime at a chain restaurant will be recorded over several weeks to study ordering habits over time. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Provide menu with visual cue and calorie information, Provide menu with visual cue but no calorie information and Provide menu with no visual cue but with calorie information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- 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
- Customers of two chain restaurants
Who cannot join
- Unable to read a written menu
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of the study is to better understand how individuals make decisions regarding the meals they order. Participants' ordering decisions at lunchtime at a chain restaurant will be recorded over several weeks to study ordering habits over time. Lunch menus will be provided by the study, and the menu format will vary the way in which information on caloric content is displayed.
The impact of different labeling formats on total calories in the chosen meal will be assessed.
- Conditions
- Obesity
- Being tested
- Provide menu with visual cue and calorie information, Provide menu with visual cue but no calorie information, Provide menu with no visual cue but with calorie information, Provide menu with no visual cue and no calorie information
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provide menu with visual cue and calorie informationBehavioural
Menu to be provided prior to placing the food order.
Provide menu with visual cue but no calorie informationBehavioural
Menu to be provided prior to placing the food order.
Provide menu with no visual cue but with calorie informationBehavioural
Menu to be provided prior to placing the food order.
Provide menu with no visual cue and no calorie informationBehavioural
Menu to be provided prior to placing the food order.
| Study group | Role | What they receive |
|---|---|---|
| Visual cue absent | Active comparator | Not described Receives: Behavioral: Provide menu with no visual cue but with calorie information; Behavioral: Provide menu with no visual cue and no calorie information |
| Calorie information present | Experimental | Not described Receives: Behavioral: Provide menu with visual cue and calorie information; Behavioral: Provide menu with no visual cue but with calorie information |
| Calorie information absent | Active comparator | Not described Receives: Behavioral: Provide menu with visual cue but no calorie information; Behavioral: Provide menu with no visual cue and no calorie information |
| Visual cue present | Experimental | Not described Receives: Behavioral: Provide menu with visual cue and calorie information; Behavioral: Provide menu with visual cue but no calorie information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories chosen
Total calories in food ordered for lunch
Measured: One time only or 6 months
Secondary outcomes (1)
Weight change
Half of the study participants will have the secondary outcome measure data collected and analyzed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Julie Downs, PhD, Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346449
- Sponsor's protocol ID
- 812950
- Other IDs
- P30AG034546
- Status last verified
- Apr 2017
- First submitted
- 28 Jan 2011
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Calories Count: Information Format and Food Choice
- ClinicalTrials.gov ID
- NCT01346449
- Acronym / sponsor ID
- 812950
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 May 2011 (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.
The purpose of the study is to better understand how individuals make decisions regarding the meals they order. Participants' ordering decisions at lunchtime at a chain restaurant will be recorded over several weeks to study ordering habits over time. Lunch menus will be provided by the study, and the menu format will vary the way in which information on caloric content is displayed.
The impact of different labeling formats on total calories in the chosen meal will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Visual cue absent | Active comparator | Behavioral: Provide menu with no visual cue but with calorie information, Behavioral: Provide menu with no visual cue and no calorie information |
| Calorie information present | Experimental | Behavioral: Provide menu with visual cue and calorie information, Behavioral: Provide menu with no visual cue but with calorie information |
| Calorie information absent | Active comparator | Behavioral: Provide menu with visual cue but no calorie information, Behavioral: Provide menu with no visual cue and no calorie information |
| Visual cue present | Experimental | Behavioral: Provide menu with visual cue and calorie information, Behavioral: Provide menu with visual cue but no calorie information |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Customers of two chain restaurants
Key exclusion criteria (1 listed)
- Unable to read a written menu
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 |
|---|---|---|
| Provide menu with visual cue and calorie informationMenu to be provided prior to placing the food order. | Behavioural | Calorie information present, Visual cue present |
| Provide menu with visual cue but no calorie informationMenu to be provided prior to placing the food order. | Behavioural | Calorie information absent, Visual cue present |
| Provide menu with no visual cue but with calorie informationMenu to be provided prior to placing the food order. | Behavioural | Calorie information present, Visual cue absent |
| Provide menu with no visual cue and no calorie informationMenu to be provided prior to placing the food order. | Behavioural | Calorie information absent, Visual cue absent |
Primary outcome
Calories chosen
Time frame: One time only or 6 months
Total calories in food ordered for lunch
1 secondary outcome
Weight change
Time frame: 6 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 13 Apr 2017.
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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.
Julie Downs, PhD principal investigator
Carnegie Mellon 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 Provide menu with visual cue and calorie information, Provide menu with visual cue but no calorie information and Provide menu with no visual cue but with calorie information in people with Obesity, run by University of Pennsylvania 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 13 Apr 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?
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 chosen (time frame: One time only or 6 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 13 Apr 2017.