Impact of Warnings on Sugar-Sweetened Beverages

Dietary Habits Clinical Trial

Official title:

Randomized Controlled Trial Evaluating the Impact of Warnings on Sugar-Sweetened Beverages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223687
• Other study ID #: 19-0277b
• Secondary ID: RWJF76290K01HL14
• Status: Completed
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: March 24, 2021

Study information

• Verified date: August 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: March 24, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dietary Habits

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Heart, Lung, and Blood Institute (NHLBI), Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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