ObesityNCT03648138
Testing the Influence of Different Sugary Drink Warning Label Designs
A study testing Sugary drink warning labels in people with Obesity and Weight Gain, run by University of Pennsylvania at 1 site in United States.
Trial summary
The aim of this study is to compare different sugary drink labels to see which most influence knowledge, beliefs, purchase intentions and choices. Parents of children ages 6-11 will shop in a virtual convenience store after being randomized to 1 of 4 conditions: 1) calorie labels; 2) text warning labels; 3) graphic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Weight Gain, Diabetes Type 2
- What is being tested?
- Sugary drink warning labels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,016 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2020to 28 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a primary caregiver of a child 6-to-11 years old;
- ≥18 years old; and
- can read and speak English
Who cannot join
- not a primary caregiver of a child 6-to-11 years old;
- <18 years old; and
- cannot read and/or speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Online study with GfK
Philadelphia, Pennsylvania, 19104
About this study
The aim of this study is to compare different sugary drink labels to see which most influence knowledge, beliefs, purchase intentions and choices. Parents of children ages 6-11 will shop in a virtual convenience store after being randomized to 1 of 4 conditions: 1) calorie labels; 2) text warning labels; 3) graphic sugar warning labels; or 4) graphic health warning. This study will provide data comparing the influence of sugary drink text warning labels and two kinds of graphic warning labels.
- Conditions
- Obesity, Weight Gain, Diabetes Type 2
- Being tested
- Sugary drink warning labels
- Medical subject headings
- Obesity, Weight Gain, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugary drink warning labelsBehavioural
This information appears in the description of the study arms.
| Study group | Role | What they receive |
|---|---|---|
| Calorie label | Active comparator | This arm will display a "Calories per Bottle" label on all beverages, not just sugary beverages. This label is identical to the American Beverage Association's current "Clear on Calories" labels (as of 2018). Receives: Behavioral: Sugary drink warning labels |
| Text warning label | Experimental | This arm will display similar text proposed in a recent sugary drink warning label bill in California. Sample text: WARNING: Drinking beverages with added sugar(s) contributes to obesity, type 2 diabetes, and tooth decay. The calorie label will also appear on all beverages. Receives: Behavioral: Sugary drink warning labels |
| Sugar graphic warning label | Experimental | This arm will graphically display the amount of sugar in each sugary beverage along with the same text used in the "text warning label" arm. The calorie label will also appear on all beverages. Receives: Behavioral: Sugary drink warning labels |
| Health graphic warning label | Experimental | This arm will graphically display potential negative health effects of over consuming sugary drinks for each sugary beverage, along with the same text used in the "text warning label" arm. The calorie label will also appear on all beverages. Receives: Behavioral: Sugary drink warning labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothetical beverage choice
Participants will select a beverage to purchase in the virtual store. Our outcome will be the percentage of parents choosing a 20-ounce sugary drink for their child
Measured: The survey will take up to 20 minutes
Secondary outcomes (13)
Likely to serve or buy these beverages:
Item: "How likely are you to serve or buy this product for your child in the next 4 weeks?" This will be answered on a 7-point Likert scale.
Measured: The survey will take up to 20 minutes
Parent feels good serving the beverages
Item: "Serving this product to my child would make me feel like I am doing something good for my child." This will be measured on a 7-point likert scale.
Measured: The survey will take up to 20 minutes
Child enjoyment of beverages
Item: "How much do you think your child would enjoy this product?" This will be answered on a 7-point likert scale.
Measured: The survey will take up to 20 minutes
Health beliefs and risk perceptions index
We will create this outcome by summing responses to the following 7 health perception questions 6 prompted with the statement "Drinking this product often would…". The statements end with the following health belief and risk perception language: "lead my child to gain weight," "increase my child's risk of heart disease," "increase my child's risk of diabetes," "make my child feel energized," "help my child focus at school", and "help my child live a healthy life." The other item is: "How healthy do you think this product is for your child?" Responses to questions about weight gain, heart disease, and diabetes will be reverse coded, so higher scores on the index will indicate a stronger positive health perception of the beverages. These will be scored on 7-point likert scales.
Measured: The survey will take up to 20 minutes
Estimate of how many teaspoons of added sugar are in the beverages
This variable will be measured continuously based on a text box provided to participants.
Measured: The survey will take up to 20 minutes
Perceived amount of added sugar in beverages
This variable will be measured on a 3-point Likert scale ranging from "too little for my child" to "too much for my child".
Measured: The survey will take up to 20 minutes
Noticing the label
Participants will respond "yes," "no," or "I don't know" to the item: "When you selected a beverage to buy for your child at the beginning of this survey, did you notice any labels on the beverages other than calorie information?"
Measured: The survey will take up to 20 minutes
Perceived label influence
Participants will respond: "yes", "no," or "I did not notice any labels" in response to the question of whether the label influenced their purchase.
Measured: The survey will take up to 20 minutes
Favor or oppose sugary drink warning label policy
We will compare the percentage of participants in favor of (combining somewhat favor and strongly favor), opposed to (combining somewhat oppose and strongly oppose), or neutral about the policy based on the following question: "Would you favor or oppose a government policy requiring a warning label to be placed on beverages with added sugars?" Ratings will be from -2 to 2.
Measured: The survey will take up to 20 minutes
Likelihood of label changing thoughts
Item: "If this government warning label were on a beverage, how much would it change your thoughts about the healthiness of that beverage for your child?" This will be measured on a 5-point Likert scale.
Measured: The survey will take up to 20 minutes
Encourage you to give fewer beverages to your child
Item: "If you saw this government warning label on a beverage, would the label encourage you to serve your child that beverage less often?" The responses will be measured on a 5-point Likert scale.
Measured: The survey will take up to 20 minutes
How much do you trust the information on this label
Item: "How much do you trust the information on this label?". Responses will be measured on a 7-point Likert scale.
Measured: The survey will take up to 20 minutes
Negative reactions to the label
We will examine the average negative emotional response to the label (said the warning label made them feel worried, fearful, guilty, or disgusted or grossed out). Each emotion will be scored on a 5-pt likert scale.
Measured: The survey will take up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start17 Jan 2020
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
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 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
- 1,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University, New York University, University of Connecticut, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Christina Roberto, University of Pennsylvania
- Investigators
- Christina A Roberto, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648138
- Sponsor's protocol ID
- 828087
- Other IDs
- R01DK111558
- Status last verified
- Mar 2020
- First submitted
- 7 Aug 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share a de-identified dataset via an online data storage website (e.g., open science framework, dataverse, research box)
Publications
Musicus AA, Gibson LA, Bellamy SL, Orr JA, Hammond D, Glanz K, Volpp KG, Schwartz MB, Bleakley A, Strasser AA, Roberto CA. Effects of Sugary Beverage Text and Pictorial Warnings: A Randomized Trial. Am J Prev Med. 2023 May;64(5):716-727. doi: 10.1016/j.amepre.2023.01.018. Epub 2023 Feb 8.
PubMed 36764835
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Influence of Different Sugary Drink Warning Label Designs
- ClinicalTrials.gov ID
- NCT03648138
- Acronym / sponsor ID
- 828087
- Conditions
- Obesity, Weight Gain, Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Drexel University, New York University, University of Connecticut, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- 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 aim of this study is to compare different sugary drink labels to see which most influence knowledge, beliefs, purchase intentions and choices. Parents of children ages 6-11 will shop in a virtual convenience store after being randomized to 1 of 4 conditions: 1) calorie labels; 2) text warning labels; 3) graphic sugar warning labels; or 4) graphic health warning. This study will provide data comparing the influence of sugary drink text warning labels and two kinds of graphic warning labels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calorie label | Active comparator | Behavioral: Sugary drink warning labelsThis arm will display a "Calories per Bottle" label on all beverages, not just sugary beverages. This label is identical to the American Beverage Association's current "Clear on Calories" labels (as of 2018). |
| Text warning label | Experimental | Behavioral: Sugary drink warning labelsThis arm will display similar text proposed in a recent sugary drink warning label bill in California. Sample text: WARNING: Drinking beverages with added sugar(s) contributes to obesity, type 2 diabetes, and tooth decay. The calorie label will also appear on all beverages. |
| Sugar graphic warning label | Experimental | Behavioral: Sugary drink warning labelsThis arm will graphically display the amount of sugar in each sugary beverage along with the same text used in the "text warning label" arm. The calorie label will also appear on all beverages. |
| Health graphic warning label | Experimental | Behavioral: Sugary drink warning labelsThis arm will graphically display potential negative health effects of over consuming sugary drinks for each sugary beverage, along with the same text used in the "text warning label" arm. The calorie label will also appear on all beverages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a primary caregiver of a child 6-to-11 years old;
- ≥18 years old; and
- can read and speak English
Key exclusion criteria (3 listed)
- not a primary caregiver of a child 6-to-11 years old;
- <18 years old; and
- cannot read and/or speak English
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 |
|---|---|---|
| Sugary drink warning labelsThis information appears in the description of the study arms. | Behavioural | Calorie label, Health graphic warning label, Sugar graphic warning label, Text warning label |
Primary outcome
Hypothetical beverage choice
Time frame: The survey will take up to 20 minutes
Participants will select a beverage to purchase in the virtual store. Our outcome will be the percentage of parents choosing a 20-ounce sugary drink for their child
13 secondary outcomes
Likely to serve or buy these beverages:
Time frame: The survey will take up to 20 minutes
Parent feels good serving the beverages
Time frame: The survey will take up to 20 minutes
Child enjoyment of beverages
Time frame: The survey will take up to 20 minutes
Health beliefs and risk perceptions index
Time frame: The survey will take up to 20 minutes
Estimate of how many teaspoons of added sugar are in the beverages
Time frame: The survey will take up to 20 minutes
Perceived amount of added sugar in beverages
Time frame: The survey will take up to 20 minutes
Noticing the label
Time frame: The survey will take up to 20 minutes
Perceived label influence
Time frame: The survey will take up to 20 minutes
Favor or oppose sugary drink warning label policy
Time frame: The survey will take up to 20 minutes
Likelihood of label changing thoughts
Time frame: The survey will take up to 20 minutes
Encourage you to give fewer beverages to your child
Time frame: The survey will take up to 20 minutes
How much do you trust the information on this label
Time frame: The survey will take up to 20 minutes
Negative reactions to the label
Time frame: The survey will take up to 20 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 11 Mar 2020.
- Derived from this study: PubMed 36764835Musicus AA, Gibson LA, Bellamy SL, Orr JA, Hammond D, Glanz K, Volpp KG, Schwartz MB, Bleakley A, Strasser AA, Roberto CA. Effects of Sugary Beverage Text and Pictorial Warnings: A Randomized Trial. Am J Prev Med. 2023 May;64(5):716-727. doi: 10.1016/j.amepre.2023.01.018. Epub 2023 Feb 8.
- Individual participant dataSharing planned: Yes. We will share a de-identified dataset via an online data storage website (e.g., open science framework, dataverse, research box)
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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.
Christina A Roberto, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugary drink warning labels in people with Obesity and Weight Gain, 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 3 inclusion and 3 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 11 Mar 2020. 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?
Hypothetical beverage choice (time frame: The survey will take up to 20 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 NCT03648138, 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 11 Mar 2020.