Food PreferencesNCT04259385
Effects of Sugary Drink Warning Labels on Parent Choices
A study testing Exposure to sugar-sweetened beverage warning labels and Exposure to beverage calorie information in people with Food Preferences, run by University of Pennsylvania at 1 site in United States.
Trial summary
Sugar-sweetened beverages (SSBs) are a significant contributor to adult and childhood obesity. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on how such labels influence people. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Preferences
- What is being tested?
- Exposure to sugar-sweetened beverage warning labels and Exposure to beverage calorie information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 12 Mar 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participant pairs must be:
- Primary caregiver of a child 6-11 years old; 18 years or older; can read and speak English; did not participate in related studies from our group
- Child is between 6 and 11 years old; drinks SSBs at least 12 times per month (~3 times per week)
Who cannot join
- Unable to participate in person in Philadelphia
- Parent did not purchase food and beverage for their child
- Parent or caregiver refused to give child permission to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effects of Sugary Drink Warning Labels on Parent Choices for 6-11 Year Olds
Sugar-sweetened beverages (SSBs) are a significant contributor to adult and childhood obesity. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on how such labels influence people. The proposed research will evaluate the impact of different types of sugar-sweetened beverage warning labels relative to standard calorie labels on the purchasing and consumption behaviors of parents and children.
Read the detailed description
The primary objective of this proposal is to determine, before wide-scale implementation, to what degree SSB warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB intake. The study is designed to answer two additional questions: 1) Do some warning labels work better than others? 3) If warning labels influence behavior, is it because they increase knowledge or simply provide a salient reminder that some drinks are less healthy? This aim is designed to test the effect of warning labels on total kilocalories (kcals) purchased and consumed by parents and children. We will examine how SSB warning labels influence snack and beverage purchases and intake among 405 racially and ethnically diverse parent-child pairs.
- Conditions
- Food Preferences
- Being tested
- Exposure to sugar-sweetened beverage warning labels, Exposure to beverage calorie information
- Keywords
- Food labeling, Child, Sugar-sweetened beverages, Eating, Drinking, Choice behavior
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to sugar-sweetened beverage warning labelsBehavioural
Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels
Exposure to beverage calorie informationBehavioural
Calories for sugar-sweetened and non-sugar-sweetened beverages
| Study group | Role | What they receive |
|---|---|---|
| Calorie/Control Label Condition | Active comparator | Beverages at the concession stand and in the parent survey in this arm will display solely a calorie label. Receives: Behavioral: Exposure to beverage calorie information |
| Text Warning Label Condition | Experimental | Sugary beverages at the concession stand and in the parent survey in this arm will display both a text warning and a calorie label. Receives: Behavioral: Exposure to sugar-sweetened beverage warning labels; Behavioral: Exposure to beverage calorie information |
| Sugar Graphic Label Condition | Experimental | Sugary beverages at the concession stand and in the parent survey in this arm will display a sugar graphic warning label depicting the amount of sugar in the product, the same text warning, and a calorie label. Receives: Behavioral: Exposure to sugar-sweetened beverage warning labels; Behavioral: Exposure to beverage calorie information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total beverage calories purchased for the child
Total number of calories for all beverages purchased for the child during the study visit
Measured: Study visit, one hour
Total calories purchased for the child
Total number of calories for all food and beverages (summed) purchased for the child during the study visit
Measured: Study visit, one hour
Total calories the child consumes
Total number of calories consumed by the child for all food and beverages (summed) during the study visit
Measured: Study visit, one hour
Secondary outcomes (5)
Total beverage calories purchased for the adult
Total number of calories for all beverages purchased for the adult during the study visit
Measured: Study visit, one hour
Total calories purchased for the adult
Total number of calories for all food and beverages (summed) purchased for the adult during the study visit
Measured: Study visit, one hour
Beverage calories the child consumes
Total number of calories consumed by the child for all beverages during the study visit
Measured: Study visit, one hour
Beverage calories the adult consumes
Total number of calories consumed by the adult for all beverages during the study visit
Measured: Study visit, one hour
Total calories the adult consumes
Total number of calories consumed by the adult for all food and beverages (summed) during the study visit
Measured: Study visit, one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start11 Mar 2020
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Study halted prematurely during COVID-19 outbreak (only 1 participant)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food PreferencesStudies 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
- Parallel groups
- Model description
- This randomized, controlled lab-based study will capture beverage and snack purchases from a concession stand and measure how much participants consume while watching a television show. Participants will be randomized to 1 of 3 groups: 1) calorie labels (control); 2) text warning labels; or 3) graphic warning labels displaying amounts of sugar.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Drexel University, University of Connecticut, New York University, University of Delaware
- Responsible party
- Principal investigator, Christina Roberto, PHD, University of Pennsylvania
- Investigators
- Christina A Roberto, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259385
- Sponsor's protocol ID
- R01DK111558_2
- Other IDs
- R01DK111558, 33648
- Status last verified
- Sep 2021
- First submitted
- 4 Feb 2020
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sugary Drink Warning Labels on Parent Choices for 6-11 Year Olds
- ClinicalTrials.gov ID
- NCT04259385
- Acronym / sponsor ID
- R01DK111558_2
- Conditions
- Food Preferences
- Keywords
- Food labeling, Child, Sugar-sweetened beverages, Eating, Drinking, Choice behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely during COVID-19 outbreak (only 1 participant)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Drexel University, University of Connecticut, New York University, University of Delaware
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 6 Feb 2020 (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.
Sugar-sweetened beverages (SSBs) are a significant contributor to adult and childhood obesity. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on how such labels influence people. The proposed research will evaluate the impact of different types of sugar-sweetened beverage warning labels relative to standard calorie labels on the purchasing and consumption behaviors of parents and children.
Detailed description
The primary objective of this proposal is to determine, before wide-scale implementation, to what degree SSB warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB intake. The study is designed to answer two additional questions: 1) Do some warning labels work better than others? 3) If warning labels influence behavior, is it because they increase knowledge or simply provide a salient reminder that some drinks are less healthy? This aim is designed to test the effect of warning labels on total kilocalories (kcals) purchased and consumed by parents and children. We will examine how SSB warning labels influence snack and beverage purchases and intake among 405 racially and ethnically diverse parent-child pairs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This randomized, controlled lab-based study will capture beverage and snack purchases from a concession stand and measure how much participants consume while watching a television show. Participants will be randomized to 1 of 3 groups: 1) calorie labels (control); 2) text warning labels; or 3) graphic warning labels displaying amounts of sugar.
| Arm | Type | Receives |
|---|---|---|
| Calorie/Control Label Condition | Active comparator | Behavioral: Exposure to beverage calorie informationBeverages at the concession stand and in the parent survey in this arm will display solely a calorie label. |
| Text Warning Label Condition | Experimental | Behavioral: Exposure to sugar-sweetened beverage warning labels, Behavioral: Exposure to beverage calorie informationSugary beverages at the concession stand and in the parent survey in this arm will display both a text warning and a calorie label. |
| Sugar Graphic Label Condition | Experimental | Behavioral: Exposure to sugar-sweetened beverage warning labels, Behavioral: Exposure to beverage calorie informationSugary beverages at the concession stand and in the parent survey in this arm will display a sugar graphic warning label depicting the amount of sugar in the product, the same text warning, and a calorie label. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participant pairs must be:
- Primary caregiver of a child 6-11 years old; 18 years or older; can read and speak English; did not participate in related studies from our group
- Child is between 6 and 11 years old; drinks SSBs at least 12 times per month (~3 times per week)
Key exclusion criteria (3 listed)
- Unable to participate in person in Philadelphia
- Parent did not purchase food and beverage for their child
- Parent or caregiver refused to give child permission to participate
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 |
|---|---|---|
| Exposure to sugar-sweetened beverage warning labelsGraphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels | Behavioural | Sugar Graphic Label Condition, Text Warning Label Condition |
| Exposure to beverage calorie informationCalories for sugar-sweetened and non-sugar-sweetened beverages | Behavioural | Calorie/Control Label Condition, Sugar Graphic Label Condition, Text Warning Label Condition |
Primary outcome
Total beverage calories purchased for the child
Time frame: Study visit, one hour
Total number of calories for all beverages purchased for the child during the study visit
Total calories purchased for the child
Time frame: Study visit, one hour
Total number of calories for all food and beverages (summed) purchased for the child during the study visit
Total calories the child consumes
Time frame: Study visit, one hour
Total number of calories consumed by the child for all food and beverages (summed) during the study visit
5 secondary outcomes
Total beverage calories purchased for the adult
Time frame: Study visit, one hour
Total calories purchased for the adult
Time frame: Study visit, one hour
Beverage calories the child consumes
Time frame: Study visit, one hour
Beverage calories the adult consumes
Time frame: Study visit, one hour
Total calories the adult consumes
Time frame: Study visit, one hour
Results and safety
The study was stopped early (reason given: Study halted prematurely during COVID-19 outbreak (only 1 participant)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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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 Exposure to sugar-sweetened beverage warning labels and Exposure to beverage calorie information in people with Food Preferences, 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: stopped early, as of the sponsor's last update on 20 Sep 2021. 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 was stopped early (reason given: Study halted prematurely during COVID-19 outbreak (only 1 participant)). Results are not available in the source record.
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 beverage calories purchased for the child (time frame: Study visit, one hour). The study lists 3 primary outcomes in all. 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 20 Sep 2021.