HealthyNCT02744859
Do Warning Labels Decrease Soda Purchasing?
A study testing Label Condition in people with Healthy, run by Harvard University.
Trial summary
Investigators will run a field study evaluating the impact different labels have on the purchasing of sugar sweetened beverages. This field study will take place in a hospital cafeteria. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Label Condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2016
- 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 the hospital cafeteria.
Who cannot join
- None
About this study
Investigators will run a field study evaluating the impact different labels have on the purchasing of sugar sweetened beverages. This field study will take place in a hospital cafeteria.
Read the detailed description
In a hospital cafeteria investigators will label all sugar sweetened beverages to evaluate their impact on purchasing.
Investigators will collect baseline data for two weeks on beverage sales at the hospital cafe. Following this data collection investigators will introduce a calorie label which reads "Each beverage contains [lower calorie bound]-[upper calorie bound] calories per container. 2,000 calories a day is used for general nutrition advice but calorie needs vary." These signs will be posted for two weeks and investigators will collect sales data. Following this intervention investigators will remove the signs and collect sales data for two weeks. At the end of this no label period, investigators will introduce the second intervention, a warning label. This label will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay." This label will also be posted for two weeks and investigators will collect sales data. Investigators will then remove these signs and collect sales data for two weeks. Finally, investigators will introduce the third intervention: a warning label with graphic labels. This label will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes and tooth decay." However this sign will also include a visual depiction of each health consequence. Investigators will collect sales data for this two week period. After this intervention investigators will collect sales data for an additional two weeks and then administer a brief survey to cafeteria customers to better understand their impressions of the labels.
- Conditions
- Healthy
- Being tested
- Label Condition
- Keywords
- Decision Making, Consumption, Economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Label ConditionOther
Labels will be presented in front of drinks. We will vary the messaging presented to the consumer.
| Study group | Role | What they receive |
|---|---|---|
| Calorie Label | Experimental | Labels will read "[lower calorie bound] - [upper calorie bound] calories per container. 2,000 calories a day is used for general nutrition advice but calorie needs vary." Receives: Other: Label Condition |
| Warning Label | Experimental | Labels will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay." Receives: Other: Label Condition |
| Warning Label with Graphics | Experimental | Labels will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay." These labels will also have graphic depictions of each health condition above the corresponding text. Receives: Other: Label Condition |
| No label | No intervention | We will also have a condition where no labels are presented-- business as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweetened beverages purchased
We will sum the total number of sugar sweetened beverages sold in each condition using the Universal Product Code (UPC) for bottled beverages and syrup weight for fountain beverages.
Measured: 2 week condition blocks
Secondary outcomes (3)
Unsweetened beverages purchased
We will sum the total number of unsweetened beverages sold in each condition using the Universal Product Code (UPC) for bottled beverages and syrup weight for fountain beverages.
Measured: 2 week condition blocks
Beverage calories sold
We will calculate the number of beverage calories sold during each condition, using the Universal Product Code (UPC) for bottled beverages, syrup weight for fountain beverages, and the products' nutritional information.
Measured: 2 week condition blocks
Changes in types of beverages purchased
We will examine any changes in the types of beverages purchased during each condition, using the Universal Product Code (UPC) for bottled beverages and syrup weight for fountain beverages. For example, if sugar-sweetened beverages sales decrease, do purchases of water increase?
Measured: 2 week condition blocks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie John, Harvard University
- Investigators
- Grant E Donnelly, MA, Principal investigator, Harvard UniversityLaura Y Zatz, MPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744859
- Sponsor's protocol ID
- IRB16-0222
- Status last verified
- Oct 2018
- First submitted
- 13 Apr 2016
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Donnelly GE, Zatz LY, Svirsky D, John LK. The Effect of Graphic Warnings on Sugary-Drink Purchasing. Psychol Sci. 2018 Aug;29(8):1321-1333. doi: 10.1177/0956797618766361. Epub 2018 Jun 18.
PubMed 29912624
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Warning Labels Decrease Soda Purchasing?
- ClinicalTrials.gov ID
- NCT02744859
- Acronym / sponsor ID
- IRB16-0222
- Conditions
- Healthy
- Keywords
- Decision Making, Consumption, Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Apr 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.
Investigators will run a field study evaluating the impact different labels have on the purchasing of sugar sweetened beverages. This field study will take place in a hospital cafeteria.
Detailed description
In a hospital cafeteria investigators will label all sugar sweetened beverages to evaluate their impact on purchasing.
Investigators will collect baseline data for two weeks on beverage sales at the hospital cafe. Following this data collection investigators will introduce a calorie label which reads "Each beverage contains [lower calorie bound]-[upper calorie bound] calories per container. 2,000 calories a day is used for general nutrition advice but calorie needs vary." These signs will be posted for two weeks and investigators will collect sales data. Following this intervention investigators will remove the signs and collect sales data for two weeks. At the end of this no label period, investigators will introduce the second intervention, a warning label. This label will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay." This label will also be posted for two weeks and investigators will collect sales data. Investigators will then remove these signs and collect sales data for two weeks. Finally, investigators will introduce the third intervention: a warning label with graphic labels. This label will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes and tooth decay." However this sign will also include a visual depiction of each health consequence. Investigators will collect sales data for this two week period. After this intervention investigators will collect sales data for an additional two weeks and then administer a brief survey to cafeteria customers to better understand their impressions of the labels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calorie Label | Experimental | Other: Label ConditionLabels will read "[lower calorie bound] - [upper calorie bound] calories per container. 2,000 calories a day is used for general nutrition advice but calorie needs vary." |
| Warning Label | Experimental | Other: Label ConditionLabels will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay." |
| Warning Label with Graphics | Experimental | Other: Label ConditionLabels will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay." These labels will also have graphic depictions of each health condition above the corresponding text. |
| No label | No intervention | –We will also have a condition where no labels are presented-- business as usual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Customers of the hospital cafeteria.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Label ConditionLabels will be presented in front of drinks. We will vary the messaging presented to the consumer. | Other | Calorie Label, Warning Label, Warning Label with Graphics |
Primary outcome
Sweetened beverages purchased
Time frame: 2 week condition blocks
We will sum the total number of sugar sweetened beverages sold in each condition using the Universal Product Code (UPC) for bottled beverages and syrup weight for fountain beverages.
3 secondary outcomes
Unsweetened beverages purchased
Time frame: 2 week condition blocks
Beverage calories sold
Time frame: 2 week condition blocks
Changes in types of beverages purchased
Time frame: 2 week condition blocks
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 4 Oct 2018.
- Derived from this study: PubMed 29912624Donnelly GE, Zatz LY, Svirsky D, John LK. The Effect of Graphic Warnings on Sugary-Drink Purchasing. Psychol Sci. 2018 Aug;29(8):1321-1333. doi: 10.1177/0956797618766361. Epub 2018 Jun 18.
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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.
Grant E Donnelly, MA principal investigator
Harvard University
Laura Y Zatz, MPH principal investigator
Harvard School of Public Health (HSPH)
Questions about this trial
What is this clinical trial studying?
A study testing Label Condition in people with Healthy, run by Harvard University.
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 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Sweetened beverages purchased (time frame: 2 week condition blocks). 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 NCT02744859, which also lists 1 linked publication.
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 4 Oct 2018.