Impact of Warnings on Sugar-Sweetened Beverages

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.

Study Overview

• Status: Completed
• Conditions: Dietary Habits
• Intervention / Treatment: Other: Sugar-Sweetened Beverage Warning Label; Other: Neutral label

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 Type: Interventional
• Enrollment (Actual): 326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugar-Sweetened Beverage Warning Label	Other: Sugar-Sweetened Beverage Warning Label; 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.
Other: Neutral label	Other: Neutral label; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At completion of ~10 minute shopping task, during 1-time study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Anticipated Avoidance of Label	Avoidance of 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 amount of avoidance of looking at the study labels.	Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Perceived Message Effectiveness	Perceived message effectiveness of 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 perceived message effectiveness of the study labels.	Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Mean Policy Support	Support for sugar-sweetened beverage health warning labels will be measured at post-test by survey. Response options are on a 1 to 4 scale, with higher scores representing a higher amount of support for a sugar-sweetened beverage health warning label policy.	Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Marissa G. Hall, PhD, University of North Carolina, Chapel Hill; Principal Investigator: Lindsey S. Taillie, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): March 24, 2021
• Study Completion (Actual): March 24, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Sugar-sweetened beverages; Beverages; Food and beverage purchases
• Other Study ID Numbers: 19-0277b; K01HL147713 (U.S. NIH Grant/Contract); RWJF76290 (Other Grant/Funding Number: Robert Wood Johnson Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No