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Clinical Trials/NCT04223687
NCT04223687CompletedNot Applicable

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

University of North Carolina, Chapel Hill2 sites in 1 country326 target enrollmentStarted: January 29, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
326
Locations
2
Primary Endpoint
Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Mean Total Calories Purchased From Sugar-sweetened Beverages(At completion of ~10 minute shopping task, during 1-time study visit)
  • Mean Intention to Give Sugar-sweetened Beverages to Child(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Percentage of Participants Who Noticed Trial Label(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean 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(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Anticipated Social Interactions(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(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean 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(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Healthfulness of Sugar-sweetened Beverages for Child(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Appeal of Sugar-sweetened Beverages for Child(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Tastiness of Sugar-sweetened Beverages for 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(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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