Dietary HabitsNCT04223687
Impact of Warnings on Sugar-Sweetened Beverages
A study testing Sugar-Sweetened Beverage Warning Label and Neutral label in people with Dietary Habits, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to determine whether pictorial warnings on sugar-sweetened beverages are more effective than neutral labels at reducing parents' purchases of sugar-sweetened beverages for their children. Participants will be parents or guardians of at least one child age 2-12. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Sugar-Sweetened Beverage Warning Label and Neutral label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to 24 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years or older
- Be able to read and speak English or Spanish
- Be able to take a computer survey in English or Spanish
- Be the parent or guardian to at least one child between the ages of 2 and 12 who consumed at least one sugar-sweetened beverage in the week prior to taking the screener
Who cannot join
- Cannot have participated in the investigator's previous study at the convenience store in the past year
- Cannot live in the same household as another enrolled study participant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Randomized Controlled Trial Evaluating the Impact of Warnings on Sugar-Sweetened Beverages
The purpose of this randomized controlled trial is to determine whether pictorial warnings on sugar-sweetened beverages are more effective than neutral labels at reducing parents' purchases of sugar-sweetened beverages for their children. Participants will be parents or guardians of at least one child age 2-12. The trial will take place in a mock convenience store. Participants will be randomly assigned to a pictorial warnings arm in which all sugar-sweetened beverages in the store are labeled with pictorial warnings, or to a control arm in which all sugar-sweetened beverages in the store are labeled with a neutral label. All participants will visit the mock convenience store setup based on their randomized trial arm and be instructed to engage in a shopping task. Participants will complete a computer survey after the shopping task.
Read the detailed description
Childhood obesity is a major public health problem in the US among racial and ethnic minorities, including among the US's growing Latino population. One promising but understudied policy for addressing childhood obesity is requiring pictorial warnings on the front of sugar-sweetened beverage containers. The impact of pictorial warnings in real-world food retail environments on parents' sugar-sweetened beverage purchasing behavior for their children is unknown. This study will assess the impact of pictorial warnings on parents' sugar-sweetened beverage purchases for their children in a real-world randomized controlled trial. The investigators focus on parents as they are the primary decision-makers and purchasers of food products for children and exert strong influence over their children's dietary intake and food attitudes. Half of participants will be Latino as childhood obesity is a major public health problem among the US's growing Latino population.
Setting: The trial will take place in a mock convenience store setting created for researchers to examine how store and product characteristics influence consumer purchases in a controlled but realistic environment. The store reflects a convenience store's characteristics, with foods, beverages, and household items set at real-world prices.
Recruitment: Participants will be recruited locally via methods including community subject pools, printed flyers posted, and online listings. Interested potential participants will complete a screening questionnaire online, in person, or over the phone to determine their eligibility. If eligible, they will be invited to schedule a time to visit the mock store for the trial.
Informed Consent: At the beginning of the in-person study visit, study staff will explain the consent form. The study staff will ask the participant if he or she has any questions; once the participant consents to the study, both parties will sign the consent form and the participant will receive a copy of the consent form.
Randomization: After the participant signs the consent form, study staff will randomly assign participants to one of the two study arms. Randomization order will be determined a priori. Participants will have an equal chance of being randomized to either arm of the trial.
Assessment: Using an established protocol, participants will visit the mock study convenience store and be given a shopping task to select 1 beverage and 1 snack to purchase for their child ages 2-12. If the participant has more than one child age 2-12, the investigators will randomly select the child they should shop for. At check-out, study staff will record the products selected. Participants will then complete 1 computer-based survey immediately after completing the shopping task. The visit will take approximately 45-60 minutes. At the end of the study, participants will receive an informational handout about sugar-sweetened beverages and healthier alternatives.
Detailed description of the trial arms: Participants will be assigned to either a pictorial warnings arm or a control arm. In the pictorial warnings arm, all sugar-sweetened beverage products in the mock store will be labeled with a pictorial warning label (two different warning labels will be displayed at the same time, but only 1 warning label per product). Investigators developed the text and design of these warning labels using a pre-test. In the control arm, all sugar-sweetened beverage products will be labeled with a neutral label, also developed by the investigators. In both arms, labels will be adhered directly on the front-of-package of sugar-sweetened beverage containers.
- Conditions
- Dietary Habits
- Being tested
- Sugar-Sweetened Beverage Warning Label, Neutral label
- Keywords
- Food and beverage purchases, Sugar-sweetened beverages, Beverages
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar-Sweetened Beverage Warning LabelOther
Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
Neutral labelOther
Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
| Study group | Role | What they receive |
|---|---|---|
| Sugar-Sweetened Beverage Warning Label | Experimental | Not described Receives: Other: Sugar-Sweetened Beverage Warning Label |
| Neutral label | Other | Not described Receives: Other: Neutral label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child
The primary outcome is the percent of participants who selected at least one sugar-sweetened beverage for their child during the shopping task. Purchases will be recorded by the experimenter when they complete the shopping task.
Measured: At completion of ~10 minute shopping task, during 1-time study visit
Secondary outcomes (13)
Mean Total Calories Purchased From Sugar-sweetened Beverages
Total calories purchased from sugar-sweetened beverages is defined as the total number of calories of sugar-sweetened beverages in the participant's basket when they complete the shopping task.
Measured: At completion of ~10 minute shopping task, during 1-time study visit
Mean Intention to Give Sugar-sweetened Beverages to Child
Intention to give sugar-sweetened beverages to child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher intention to give sugar-sweetened beverages to the participant's child.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Percentage of Participants Who Noticed Trial Label
Percent of participants who noticed the trial labels will be measured at post-test by survey.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Thinking About Harms of Drinking Sugar-sweetened Beverages
How much the participant reports thinking about the health problems caused by drinking sugar-sweetened beverages will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of thinking about harms of drinking sugar-sweetened beverages.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Negative Affective Reactions
Negative affect will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher negative affect reaction.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Anticipated Social Interactions
Anticipated social interactions about the study labels will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher likelihood of discussing the study labels with others.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Percentage of Participants Who Felt More in Control of Healthy Eating Decisions
Percent of participants indicating they felt more in control of healthy eating decisions will be measured at post-test by survey.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Perceived Amount of Added Sugar in Sugar-sweetened Beverages
Perceptions of added sugar content in sugar-sweetened beverages will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher perceived amount of added sugar in sugar-sweetened beverages.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Perceived Likelihood of Child Experiencing Health Problems Due to Sugar-sweetened Beverages
Perceived likelihood of child experiencing sugar-sweetened beverage related health outcomes will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher perceived likelihood of child experiencing health problems due to sugar-sweetened beverages.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Healthfulness of Sugar-sweetened Beverages for Child
Parents' perceptions about sugar-sweetened beverages' healthfulness for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher perceived healthfulness of sugar-sweetened beverages for their child.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Appeal of Sugar-sweetened Beverages for Child
Parents' perceptions about sugar-sweetened beverages appeal for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher perceived appeal of sugar-sweetened beverages for their child.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Tastiness of Sugar-sweetened Beverages for Child
Parents' perceptions of tastiness of sugar-sweetened beverages for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher perceived tastiness of sugar-sweetened beverages for their child.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Injunctive Norms About Limiting Child's Sugar-sweetened Beverages
Injunctive norms about limiting child's sugar-sweetened beverage consumption will be measured at post-test by survey. Injunctive norms refer to perceived approval from people important in the participant's life. Response options are on a 1 to 5 scale, with higher scores representing higher perceived approval about limiting their child's sugar-sweetened beverages.
Measured: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start29 Jan 2020
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marissa G. Hall, PhD, Principal investigator, University of North Carolina, Chapel HillLindsey S. Taillie, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223687
- Sponsor's protocol ID
- 19-0277b
- Other IDs
- RWJF76290, K01HL147713
- Status last verified
- Aug 2021
- First submitted
- 10 Dec 2019
- Last updated
- 1 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall MG, Grummon AH, Higgins ICA, Lazard AJ, Prestemon CE, Avendano-Galdamez MI, Taillie LS. The impact of pictorial health warnings on purchases of sugary drinks for children: A randomized controlled trial. PLoS Med. 2022 Feb 1;19(2):e1003885. doi: 10.1371/journal.pmed.1003885. eCollection 2022 Feb.
PubMed 35104297
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Impact of Warnings on Sugar-Sweetened Beverages
- ClinicalTrials.gov ID
- NCT04223687
- Acronym / sponsor ID
- 19-0277b
- Conditions
- Dietary Habits
- Keywords
- Food and beverage purchases, Sugar-sweetened beverages, Beverages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Posted 6 Aug 2021
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 this randomized controlled trial is to determine whether pictorial warnings on sugar-sweetened beverages are more effective than neutral labels at reducing parents' purchases of sugar-sweetened beverages for their children. Participants will be parents or guardians of at least one child age 2-12. The trial will take place in a mock convenience store. Participants will be randomly assigned to a pictorial warnings arm in which all sugar-sweetened beverages in the store are labeled with pictorial warnings, or to a control arm in which all sugar-sweetened beverages in the store are labeled with a neutral label. All participants will visit the mock convenience store setup based on their randomized trial arm and be instructed to engage in a shopping task. Participants will complete a computer survey after the shopping task.
Detailed description
Childhood obesity is a major public health problem in the US among racial and ethnic minorities, including among the US's growing Latino population. One promising but understudied policy for addressing childhood obesity is requiring pictorial warnings on the front of sugar-sweetened beverage containers. The impact of pictorial warnings in real-world food retail environments on parents' sugar-sweetened beverage purchasing behavior for their children is unknown. This study will assess the impact of pictorial warnings on parents' sugar-sweetened beverage purchases for their children in a real-world randomized controlled trial. The investigators focus on parents as they are the primary decision-makers and purchasers of food products for children and exert strong influence over their children's dietary intake and food attitudes. Half of participants will be Latino as childhood obesity is a major public health problem among the US's growing Latino population.
Setting: The trial will take place in a mock convenience store setting created for researchers to examine how store and product characteristics influence consumer purchases in a controlled but realistic environment. The store reflects a convenience store's characteristics, with foods, beverages, and household items set at real-world prices.
Recruitment: Participants will be recruited locally via methods including community subject pools, printed flyers posted, and online listings. Interested potential participants will complete a screening questionnaire online, in person, or over the phone to determine their eligibility. If eligible, they will be invited to schedule a time to visit the mock store for the trial.
Informed Consent: At the beginning of the in-person study visit, study staff will explain the consent form. The study staff will ask the participant if he or she has any questions; once the participant consents to the study, both parties will sign the consent form and the participant will receive a copy of the consent form.
Randomization: After the participant signs the consent form, study staff will randomly assign participants to one of the two study arms. Randomization order will be determined a priori. Participants will have an equal chance of being randomized to either arm of the trial.
Assessment: Using an established protocol, participants will visit the mock study convenience store and be given a shopping task to select 1 beverage and 1 snack to purchase for their child ages 2-12. If the participant has more than one child age 2-12, the investigators will randomly select the child they should shop for. At check-out, study staff will record the products selected. Participants will then complete 1 computer-based survey immediately after completing the shopping task. The visit will take approximately 45-60 minutes. At the end of the study, participants will receive an informational handout about sugar-sweetened beverages and healthier alternatives.
Detailed description of the trial arms: Participants will be assigned to either a pictorial warnings arm or a control arm. In the pictorial warnings arm, all sugar-sweetened beverage products in the mock store will be labeled with a pictorial warning label (two different warning labels will be displayed at the same time, but only 1 warning label per product). Investigators developed the text and design of these warning labels using a pre-test. In the control arm, all sugar-sweetened beverage products will be labeled with a neutral label, also developed by the investigators. In both arms, labels will be adhered directly on the front-of-package of sugar-sweetened beverage containers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar-Sweetened Beverage Warning Label | Experimental | Other: Sugar-Sweetened Beverage Warning Label |
| Neutral label | Other | Other: Neutral label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18 years or older
- Be able to read and speak English or Spanish
- Be able to take a computer survey in English or Spanish
- Be the parent or guardian to at least one child between the ages of 2 and 12 who consumed at least one sugar-sweetened beverage in the week prior to taking the screener
Key exclusion criteria (2 listed)
- Cannot have participated in the investigator's previous study at the convenience store in the past year
- Cannot live in the same household as another enrolled study participant
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 |
|---|---|---|
| Sugar-Sweetened Beverage Warning LabelLabels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research. | Other | Sugar-Sweetened Beverage Warning Label |
| Neutral labelNeutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels. | Other | Neutral label |
Primary outcome
Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child
Time frame: At completion of ~10 minute shopping task, during 1-time study visit
The primary outcome is the percent of participants who selected at least one sugar-sweetened beverage for their child during the shopping task. Purchases will be recorded by the experimenter when they complete the shopping task.
13 secondary outcomes
Mean Total Calories Purchased From Sugar-sweetened Beverages
Time frame: At completion of ~10 minute shopping task, during 1-time study visit
Mean Intention to Give Sugar-sweetened Beverages to Child
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Percentage of Participants Who Noticed Trial Label
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Thinking About Harms of Drinking Sugar-sweetened Beverages
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Negative Affective Reactions
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Anticipated Social Interactions
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Percentage of Participants Who Felt More in Control of Healthy Eating Decisions
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Perceived Amount of Added Sugar in Sugar-sweetened Beverages
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Perceived Likelihood of Child Experiencing Health Problems Due to Sugar-sweetened Beverages
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Healthfulness of Sugar-sweetened Beverages for Child
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Appeal of Sugar-sweetened Beverages for Child
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Tastiness of Sugar-sweetened Beverages for Child
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Injunctive Norms About Limiting Child's Sugar-sweetened Beverages
Time frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35104297Hall MG, Grummon AH, Higgins ICA, Lazard AJ, Prestemon CE, Avendano-Galdamez MI, Taillie LS. The impact of pictorial health warnings on purchases of sugary drinks for children: A randomized controlled trial. PLoS Med. 2022 Feb 1;19(2):e1003885. doi: 10.1371/journal.pmed.1003885. eCollection 2022 Feb.
- Individual participant dataSharing planned: No
Related trials for Dietary Habits
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
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.
Marissa G. Hall, PhD principal investigator
University of North Carolina, Chapel Hill
Lindsey S. Taillie, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar-Sweetened Beverage Warning Label and Neutral label in people with Dietary Habits, run by University of North Carolina, Chapel Hill 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 4 inclusion and 2 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 1 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?
Yes. Results are posted in the registry (first posted 6 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child (time frame: At completion of ~10 minute shopping task, during 1-time study visit). 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 NCT04223687, 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 1 Sep 2021.