Last reviewed · How we verify

NCT04223687

Impact of Warnings on Sugar-Sweetened Beverages

Completed NA Results posted Last updated 1 September 2021
What this trial tests

NA trial testing Sugar-Sweetened Beverage Warning Label in Dietary Habits in 326 participants. Completed in 24 March 2021.

Timeline
29 January 2020
Primary endpoint
24 March 2021
24 March 2021

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment326
Start date29 January 2020
Primary completion24 March 2021
Estimated completion24 March 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Dietary Habits. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child Primary · 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.

GroupValue95% CI
Neutral Label45
Sugar-Sweetened Beverage Warning Label28
Mean Total Calories Purchased From Sugar-sweetened Beverages Secondary · At completion of ~10 minute shopping task, during 1-time study visit

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.

GroupValue95% CI
Neutral Label82.1± 97.22
Sugar-Sweetened Beverage Warning Label51.72± 86.82
Mean Intention to Give Sugar-sweetened Beverages to Child Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

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.

GroupValue95% CI
Neutral Label1.85± 0.8
Sugar-Sweetened Beverage Warning Label1.65± 0.6
Percentage of Participants Who Noticed Trial Label Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Percent of participants who noticed the trial labels will be measured at post-test by survey.

GroupValue95% CI
Neutral Label47
Sugar-Sweetened Beverage Warning Label52
Mean Thinking About Harms of Drinking Sugar-sweetened Beverages Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

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.

GroupValue95% CI
Neutral Label1.90± 1.25
Sugar-Sweetened Beverage Warning Label4.21± 0.95
Mean Negative Affective Reactions Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

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.

GroupValue95% CI
Neutral Label1.51± 0.82
Sugar-Sweetened Beverage Warning Label3.38± 1.12
Mean Anticipated Social Interactions Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

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.

GroupValue95% CI
Neutral Label2.16± 1.32
Sugar-Sweetened Beverage Warning Label3.89± 1.24
Percentage of Participants Who Felt More in Control of Healthy Eating Decisions Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Percent of participants indicating they felt more in control of healthy eating decisions will be measured at post-test by survey.

GroupValue95% CI
Neutral Label30
Sugar-Sweetened Beverage Warning Label73
Mean Perceived Amount of Added Sugar in Sugar-sweetened Beverages Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

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.

GroupValue95% CI
Neutral Label3.99± 0.67
Sugar-Sweetened Beverage Warning Label4.08± 0.77
Mean Perceived Likelihood of Child Experiencing Health Problems Due to Sugar-sweetened Beverages Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

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.

GroupValue95% CI
Neutral Label3.95± 0.99
Sugar-Sweetened Beverage Warning Label4.07± 0.92
Mean Healthfulness of Sugar-sweetened Beverages for Child Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

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.

GroupValue95% CI
Neutral Label2.24± 0.80
Sugar-Sweetened Beverage Warning Label1.98± 0.82
Mean Appeal of Sugar-sweetened Beverages for Child Secondary · Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

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.

GroupValue95% CI
Neutral Label3.32± 0.96
Sugar-Sweetened Beverage Warning Label3.24± 0.98

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The impact of pictorial health warnings on purchases of sugary drinks for children: A randomized controlled trial.
    Hall MG, Grummon AH, Higgins ICA, Lazard AJ, et al · · 2022 · cited 30× · PMID 35104297 · DOI 10.1371/journal.pmed.1003885

Verify or expand the search:

Other recruiting trials for Dietary Habits

Currently open trials in the same condition.

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04223687.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing