ObesityNCT01061905
Behavioral Economics and Food Choice
A study testing Calorie information, Exercise Equivalent only and Calorie & Exercise equivalent information in people with Obesity and Overweight, run by University of Pennsylvania at 4 sites in United States.
Trial summary
This is the second in a series of pilot interventions we are conducting to assess how principles from behavioral economics can be applied to improve consumers' food choices. In collaboration with Aramark, the food service vendor, we intend to examine if calorie labeling in different formats impacts consumers choice of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Calorie information, Exercise Equivalent only and Calorie & Exercise equivalent information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2010to Jun 2011
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aramark Hospital Cafeteria or Cafe with the ability to provide sales data
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ARAMARK healthcare at Main Line Health
Bryn Mawr, Pennsylvania, 19010
ARAMARK Healthcare at Henry Ford Hospital
Detroit, Michigan, 48202
ARAMARK healthcare at North Shore University Health System
Evanston, Illinois, 60201
ARAMARK healthcare at Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19107
About this study
Official title: Behavioral Economics Concepts Influencing Healthy Food Choice - Pilot 2
This is the second in a series of pilot interventions we are conducting to assess how principles from behavioral economics can be applied to improve consumers' food choices. In collaboration with Aramark, the food service vendor, we intend to examine if calorie labeling in different formats impacts consumers choice of bottled beverages in hospital cafeterias. Specifically, we will be testing whether signage that conveys to consumers the number of calories in each bottled beverage will increase the number of zero-calorie beverages sold relative to non-zero-calorie beverages. Likewise, we will test whether signage that conveys calories in exercise equivalents increases the sale of zero-calorie beverages. Lastly, we will test if signage conveying standard calorie information in conjunction with exercise equivalents increases the sale of zero-calorie beverages. We will measure the differential effect of each of these three formats for calorie information.
Read the detailed description
Individual behavior plays a central role in the disease burden faced by society. Many major health problems in the United States such as obesity are exacerbated by unhealthy behaviors. In our research, we apply ideas from behavioral economics, which integrates concepts from psychology and economics, to the problem of changing health behaviors. In our research we use several of the decision biases that ordinarily lead people to self-harming behavior, to promote healthy behaviors instead. To date, we have been applying this approach to areas such as smoking cessation, weight loss and medication compliance. We were approached by Aramark to collaborate on projects to test the applicability of this approach to changing food choice. Successful pilots in this area would greatly contribute to ongoing discussions nationally on curbing the obesity epidemic. Our plan was to structure interventions to take advantage of the fact that individuals put disproportionate value on present relative to future costs and benefits, known as present-biased preferences. Present-biased preferences can be made to steer people toward healthier options if they are given immediate rewards for healthy behaviors with even small rewards, if they are immediate. Our first project with Aramark used price discounts on zero-calorie beverages as a means to make the benefits of healthier beverage choice more immediate and tangible. At 4 Aramark hospital cafeteria sites, we discounted the price of zero-calorie beverages by 10% and sought to determine the impact on consumers choice of these beverages. At this time, the intervention has just completed, and data analysis is ongoing. Besides financial incentives, as we used in our first pilot project, conveying information can also make the value of future costs and benefits more immediate. It is this principle which we plan to test with the second pilot.
This pilot intervention will use a quasi-experimental, factorial design to test the impact of calorie information presented on posters in different formats on beverage choice (zero-calorie beverage versus other drinks). At each of 4 hospital cafeteria sites, we will conduct 3 separate, consecutive interventions in which we post the following displays for bottled beverages: (A) calorie information, (B) calories plus calories as exercise equivalents, (C) calories as exercise equivalents. Each intervention will last 3 weeks with a 1 week "washout" period (no display) in between interventions. Therefore, the interventions will run for a total of 11 weeks. The order of interventions will be randomized at each site to address ordering effects. Data on bottled beverage sales (zero-calorie vs. non-zero-calorie) will be collected and analyzed at the cafeteria-level. This includes point-of-sale data, inventory, and stock-keeping-units (SKU) data of zero-calorie and regular beverages sold weekly at each site, before, during and after the pilot. In order to make appropriate comparisons across cafeterias, already-conducted site-specific demographic market research analysis on customers (in aggregate) will also be considered. No individual-level consumer data will be collected, obtained, or analyzed in this study.
The unit of analysis for these studies are hospital cafeterias and cafes which are operated by Aramark, the food services company. The cafeterias and cafes are located in a variety of hospitals located nationwide. Through discussions with Aramark, these cafeterias have volunteered to participate in this study. Representatives from Aramark have been in contact with representatives from the hospitals regarding their participation. We expect 4 Aramark sites will participate, which in total will include 6 cafeterias and 3 convenience stores. During the intervention, customers at each site will see the calorie information displays but will be under no obligation to purchase any of the beverages involved in the study.
The 11 week intervention is set to begin in early February. Data on beverage sales at each site will be collected in the weeks and months leading up to the intervention and in the weeks and months following the intervention.
There will be no individual-level data collection, only aggregate monitoring of cafeteria beverage inventory. As such there is almost no risk to human subjects, their privacy, or confidentiality.
Potential risks to humans include altered food choice that negatively affects their health. Though we will be promoting healthier options, there is a very small possibility that such promotion paradoxically may influence individuals to seek out less healthy items. There is also a small risk of such promotions such as exercise labeling to effect individuals psychologically in unexpected ways. The likelihood of both of these is very small and the seriousness of these risks also are minor.
- Conditions
- Obesity, Overweight
- Being tested
- Calorie information, Exercise Equivalent only, Calorie & Exercise equivalent information
- Keywords
- health behavior, behavioral economics, calorie labeling, exercise
- Medical subject headings
- Obesity, Overweight, Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie informationBehavioural
Posting of Calorie information for sugar-sweetened and zero-calorie beverages
Exercise Equivalent onlyBehavioural
Posting of only exercise equivalents (e.g. 45 minutes on a treadmill) for both sugar-sweetened and zero-calorie beverages, prominently on a poster.
Calorie & Exercise equivalent informationBehavioural
Posting of both calorie and exercise equivalents information for both sugar-sweetened and zero-calorie beverages, prominently on a poster.
| Study group | Role | What they receive |
|---|---|---|
| Calorie information only | Experimental | Posting calorie information of sugar-sweetened and zero-calorie beverages prominently on a poster. Receives: Behavioral: Calorie information |
| Exercise Equivalent Information | Experimental | Posting of only exercise equivalents (e.g. 45 minutes on a treadmill) for both sugar-sweetened and zero-calorie beverages, prominently on a poster. Receives: Behavioral: Exercise Equivalent only |
| Calorie and Exercise Equivalent information | Experimental | Posting of both calorie and exercise equivalent information for both sugar-sweetened and zero-calorie beverages, prominently on a poster. Receives: Behavioral: Calorie & Exercise equivalent information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome data will comprise of weekly sales and inventory reports provided by each cafeteria. Specifically, we will obtain total sales of the relevant beverages before, during, and after the study.
Measured: Weekly sales data collected duing intervention from 2/8/10 through 5/23/10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University
- Responsible party
- Principal investigator, J. Jane S. Jue, University of Pennsylvania
- Investigators
- Kevin Volpp, MD, PhD, Principal investigator, University of PennsylvaniaJ. Jane S. Jue, MD, Principal investigator, Robert Wood Johnson Foundation Clinical Scholars Program at the University of PennsylvaniaMatthew J Press, MD, Principal investigator, Robert Wood Johnson Foundation Clinical Scholars Program at the University of PennsylvaniaDavid Asch, MD, MBA, Principal investigator, University of PennsylvaniaGeorge Loewenstein, PhD, Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061905
- Sponsor's protocol ID
- WhartonAramark-BehavEcon-2
- Status last verified
- Nov 2011
- First submitted
- 29 Jan 2010
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Volpp KG, Pauly MV, Loewenstein G, Bangsberg D. P4P4P: an agenda for research on pay-for-performance for patients. Health Aff (Millwood). 2009 Jan-Feb;28(1):206-14. doi: 10.1377/hlthaff.28.1.206.
PubMed 19124872Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.
PubMed 18042920Brownell KD, Frieden TR. Ounces of prevention--the public policy case for taxes on sugared beverages. N Engl J Med. 2009 Apr 30;360(18):1805-8. doi: 10.1056/NEJMp0902392. Epub 2009 Apr 8. No abstract available.
PubMed 19357400Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.
PubMed 19213683Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
PubMed 19102784Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
PubMed 19066383Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Flegal KM, Graubard BI, Williamson DF, Gail MH. Excess deaths associated with underweight, overweight, and obesity. JAMA. 2005 Apr 20;293(15):1861-7. doi: 10.1001/jama.293.15.1861.
PubMed 15840860
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economics Concepts Influencing Healthy Food Choice - Pilot 2
- ClinicalTrials.gov ID
- NCT01061905
- Acronym / sponsor ID
- WhartonAramark-BehavEcon-2
- Conditions
- Obesity, Overweight
- Keywords
- health behavior, behavioral economics, calorie labeling, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Carnegie Mellon University
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Feb 2010 (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.
This is the second in a series of pilot interventions we are conducting to assess how principles from behavioral economics can be applied to improve consumers' food choices. In collaboration with Aramark, the food service vendor, we intend to examine if calorie labeling in different formats impacts consumers choice of bottled beverages in hospital cafeterias. Specifically, we will be testing whether signage that conveys to consumers the number of calories in each bottled beverage will increase the number of zero-calorie beverages sold relative to non-zero-calorie beverages. Likewise, we will test whether signage that conveys calories in exercise equivalents increases the sale of zero-calorie beverages. Lastly, we will test if signage conveying standard calorie information in conjunction with exercise equivalents increases the sale of zero-calorie beverages. We will measure the differential effect of each of these three formats for calorie information.
Detailed description
Individual behavior plays a central role in the disease burden faced by society. Many major health problems in the United States such as obesity are exacerbated by unhealthy behaviors. In our research, we apply ideas from behavioral economics, which integrates concepts from psychology and economics, to the problem of changing health behaviors. In our research we use several of the decision biases that ordinarily lead people to self-harming behavior, to promote healthy behaviors instead. To date, we have been applying this approach to areas such as smoking cessation, weight loss and medication compliance. We were approached by Aramark to collaborate on projects to test the applicability of this approach to changing food choice. Successful pilots in this area would greatly contribute to ongoing discussions nationally on curbing the obesity epidemic. Our plan was to structure interventions to take advantage of the fact that individuals put disproportionate value on present relative to future costs and benefits, known as present-biased preferences. Present-biased preferences can be made to steer people toward healthier options if they are given immediate rewards for healthy behaviors with even small rewards, if they are immediate. Our first project with Aramark used price discounts on zero-calorie beverages as a means to make the benefits of healthier beverage choice more immediate and tangible. At 4 Aramark hospital cafeteria sites, we discounted the price of zero-calorie beverages by 10% and sought to determine the impact on consumers choice of these beverages. At this time, the intervention has just completed, and data analysis is ongoing. Besides financial incentives, as we used in our first pilot project, conveying information can also make the value of future costs and benefits more immediate. It is this principle which we plan to test with the second pilot.
This pilot intervention will use a quasi-experimental, factorial design to test the impact of calorie information presented on posters in different formats on beverage choice (zero-calorie beverage versus other drinks). At each of 4 hospital cafeteria sites, we will conduct 3 separate, consecutive interventions in which we post the following displays for bottled beverages: (A) calorie information, (B) calories plus calories as exercise equivalents, (C) calories as exercise equivalents. Each intervention will last 3 weeks with a 1 week "washout" period (no display) in between interventions. Therefore, the interventions will run for a total of 11 weeks. The order of interventions will be randomized at each site to address ordering effects. Data on bottled beverage sales (zero-calorie vs. non-zero-calorie) will be collected and analyzed at the cafeteria-level. This includes point-of-sale data, inventory, and stock-keeping-units (SKU) data of zero-calorie and regular beverages sold weekly at each site, before, during and after the pilot. In order to make appropriate comparisons across cafeterias, already-conducted site-specific demographic market research analysis on customers (in aggregate) will also be considered. No individual-level consumer data will be collected, obtained, or analyzed in this study.
The unit of analysis for these studies are hospital cafeterias and cafes which are operated by Aramark, the food services company. The cafeterias and cafes are located in a variety of hospitals located nationwide. Through discussions with Aramark, these cafeterias have volunteered to participate in this study. Representatives from Aramark have been in contact with representatives from the hospitals regarding their participation. We expect 4 Aramark sites will participate, which in total will include 6 cafeterias and 3 convenience stores. During the intervention, customers at each site will see the calorie information displays but will be under no obligation to purchase any of the beverages involved in the study.
The 11 week intervention is set to begin in early February. Data on beverage sales at each site will be collected in the weeks and months leading up to the intervention and in the weeks and months following the intervention.
There will be no individual-level data collection, only aggregate monitoring of cafeteria beverage inventory. As such there is almost no risk to human subjects, their privacy, or confidentiality.
Potential risks to humans include altered food choice that negatively affects their health. Though we will be promoting healthier options, there is a very small possibility that such promotion paradoxically may influence individuals to seek out less healthy items. There is also a small risk of such promotions such as exercise labeling to effect individuals psychologically in unexpected ways. The likelihood of both of these is very small and the seriousness of these risks also are minor.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calorie information only | Experimental | Behavioral: Calorie informationPosting calorie information of sugar-sweetened and zero-calorie beverages prominently on a poster. |
| Exercise Equivalent Information | Experimental | Behavioral: Exercise Equivalent onlyPosting of only exercise equivalents (e.g. 45 minutes on a treadmill) for both sugar-sweetened and zero-calorie beverages, prominently on a poster. |
| Calorie and Exercise Equivalent information | Experimental | Behavioral: Calorie & Exercise equivalent informationPosting of both calorie and exercise equivalent information for both sugar-sweetened and zero-calorie beverages, prominently on a poster. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Aramark Hospital Cafeteria or Cafe with the ability to provide sales data
Key exclusion criteria (0 listed)
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 informationPosting of Calorie information for sugar-sweetened and zero-calorie beverages | Behavioural | Calorie information only |
| Exercise Equivalent onlyPosting of only exercise equivalents (e.g. 45 minutes on a treadmill) for both sugar-sweetened and zero-calorie beverages, prominently on a poster. | Behavioural | Exercise Equivalent Information |
| Calorie & Exercise equivalent informationPosting of both calorie and exercise equivalents information for both sugar-sweetened and zero-calorie beverages, prominently on a poster. | Behavioural | Calorie and Exercise Equivalent information |
Primary outcome
Primary outcome data will comprise of weekly sales and inventory reports provided by each cafeteria. Specifically, we will obtain total sales of the relevant beverages before, during, and after the study.
Time frame: Weekly sales data collected duing intervention from 2/8/10 through 5/23/10
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 16 Nov 2011.
- Background: PubMed 19124872Volpp KG, Pauly MV, Loewenstein G, Bangsberg D. P4P4P: an agenda for research on pay-for-performance for patients. Health Aff (Millwood). 2009 Jan-Feb;28(1):206-14. doi: 10.1377/hlthaff.28.1.206.
- Background: PubMed 18042920Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.
- Background: PubMed 19357400Brownell KD, Frieden TR. Ounces of prevention--the public policy case for taxes on sugared beverages. N Engl J Med. 2009 Apr 30;360(18):1805-8. doi: 10.1056/NEJMp0902392. Epub 2009 Apr 8. No abstract available.
- Results publication: PubMed 19213683Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.
- Results publication: PubMed 19102784Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
- Results publication: PubMed 19066383Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
- Results publication: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Results publication: PubMed 15840860Flegal KM, Graubard BI, Williamson DF, Gail MH. Excess deaths associated with underweight, overweight, and obesity. JAMA. 2005 Apr 20;293(15):1861-7. doi: 10.1001/jama.293.15.1861.
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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.
Kevin Volpp, MD, PhD principal investigator
University of Pennsylvania
J. Jane S. Jue, MD principal investigator
Robert Wood Johnson Foundation Clinical Scholars Program at the University of Pennsylvania
Matthew J Press, MD principal investigator
Robert Wood Johnson Foundation Clinical Scholars Program at the University of Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie information, Exercise Equivalent only and Calorie & Exercise equivalent information in people with Obesity and Overweight, run by University of Pennsylvania at 4 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 0 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 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Primary outcome data will comprise of weekly sales and inventory reports provided by each cafeteria. Specifically, we will obtain total sales of the relevant beverages before, during, and after the study. (time frame: Weekly sales data collected duing intervention from 2/8/10 through 5/23/10). 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 NCT01061905, which also lists 8 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 16 Nov 2011.