NCT04223687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

January 29, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 6, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

December 10, 2019

Results QC Date

July 14, 2021

Last Update Submit

August 6, 2021

Conditions

Keywords

Food and beverage purchasesSugar-sweetened beveragesBeverages

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • 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

  • +8 more secondary outcomes

Other Outcomes (3)

  • Mean Anticipated Avoidance of Label

    Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

  • Mean Perceived Message Effectiveness

    Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

  • Mean Policy Support

    Post-test computer survey within 30 minutes following completion of ~10 minute shopping task

Study Arms (2)

Sugar-Sweetened Beverage Warning Label

EXPERIMENTAL
Other: Sugar-Sweetened Beverage Warning Label

Neutral label

OTHER
Other: Neutral label

Interventions

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.

Sugar-Sweetened Beverage Warning 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.

Neutral label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Results Point of Contact

Title
Marissa Hall, PhD
Organization
University of North Carolina at Chapel Hill

Study Officials

  • Marissa G. Hall, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Lindsey S. Taillie, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2019

First Posted

January 10, 2020

Study Start

January 29, 2020

Primary Completion

March 24, 2021

Study Completion

March 24, 2021

Last Updated

September 1, 2021

Results First Posted

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations