Clinical trial NCT04223687: Impact of Warnings on Sugar-Sweetened Beverages
Official title: Randomized Controlled Trial Evaluating the Impact of Warnings on Sugar-Sweetened Beverages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Keywords: Food and beverage purchases
Sugar-sweetened beverages
Beverages
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-01-10
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child
timeFrame: At completion of ~10 minute shopping task, during 1-time study visit
Secondary outcomes:
measure: Mean Total Calories Purchased From Sugar-sweetened Beverages
timeFrame: At completion of ~10 minute shopping task, during 1-time study visit
measure: Mean Intention to Give Sugar-sweetened Beverages to Child
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Percentage of Participants Who Noticed Trial Label
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Thinking About Harms of Drinking Sugar-sweetened Beverages
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Negative Affective Reactions
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Anticipated Social Interactions
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Percentage of Participants Who Felt More in Control of Healthy Eating Decisions
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Perceived Amount of Added Sugar in Sugar-sweetened Beverages
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Perceived Likelihood of Child Experiencing Health Problems Due to Sugar-sweetened Beverages
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Healthfulness of Sugar-sweetened Beverages for Child
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Appeal of Sugar-sweetened Beverages for Child
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Tastiness of Sugar-sweetened Beverages for Child
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Injunctive Norms About Limiting Child's Sugar-sweetened Beverages
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Other outcomes:
measure: Mean Anticipated Avoidance of Label
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Perceived Message Effectiveness
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
measure: Mean Policy Support
timeFrame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Marissa G. Hall, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Lindsey S. Taillie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.