NCT04259385

Brief Summary

Sugar-sweetened beverages (SSBs) are a significant contributor to adult and childhood obesity. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on how such labels influence people. The proposed research will evaluate the impact of different types of sugar-sweetened beverage warning labels relative to standard calorie labels on the purchasing and consumption behaviors of parents and children.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

1 day

First QC Date

February 4, 2020

Last Update Submit

September 13, 2021

Conditions

Keywords

Food labelingChildSugar-sweetened beveragesEatingDrinkingChoice behavior

Outcome Measures

Primary Outcomes (3)

  • Total beverage calories purchased for the child

    Total number of calories for all beverages purchased for the child during the study visit

    Study visit, one hour

  • Total calories purchased for the child

    Total number of calories for all food and beverages (summed) purchased for the child during the study visit

    Study visit, one hour

  • Total calories the child consumes

    Total number of calories consumed by the child for all food and beverages (summed) during the study visit

    Study visit, one hour

Secondary Outcomes (5)

  • Total beverage calories purchased for the adult

    Study visit, one hour

  • Total calories purchased for the adult

    Study visit, one hour

  • Beverage calories the child consumes

    Study visit, one hour

  • Beverage calories the adult consumes

    Study visit, one hour

  • Total calories the adult consumes

    Study visit, one hour

Other Outcomes (10)

  • Parent sugary beverage purchase intentions for the child

    Study visit, 1 hour

  • Parent non-sugary beverage purchase intentions for the child

    Study visit, 1 hour

  • Sugary beverage health beliefs and risk perceptions for the child

    Study visit, 1 hour

  • +7 more other outcomes

Study Arms (3)

Calorie/Control Label Condition

ACTIVE COMPARATOR

Beverages at the concession stand and in the parent survey in this arm will display solely a calorie label.

Behavioral: Exposure to beverage calorie information

Text Warning Label Condition

EXPERIMENTAL

Sugary beverages at the concession stand and in the parent survey in this arm will display both a text warning and a calorie label.

Behavioral: Exposure to sugar-sweetened beverage warning labelsBehavioral: Exposure to beverage calorie information

Sugar Graphic Label Condition

EXPERIMENTAL

Sugary beverages at the concession stand and in the parent survey in this arm will display a sugar graphic warning label depicting the amount of sugar in the product, the same text warning, and a calorie label.

Behavioral: Exposure to sugar-sweetened beverage warning labelsBehavioral: Exposure to beverage calorie information

Interventions

Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels

Sugar Graphic Label ConditionText Warning Label Condition

Calories for sugar-sweetened and non-sugar-sweetened beverages

Calorie/Control Label ConditionSugar Graphic Label ConditionText Warning Label Condition

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participant pairs must be:
  • Primary caregiver of a child 6-11 years old; 18 years or older; can read and speak English; did not participate in related studies from our group
  • Child is between 6 and 11 years old; drinks SSBs at least 12 times per month (\~3 times per week)

You may not qualify if:

  • Unable to participate in person in Philadelphia
  • Parent did not purchase food and beverage for their child
  • Parent or caregiver refused to give child permission to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Christina A Roberto, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This randomized, controlled lab-based study will capture beverage and snack purchases from a concession stand and measure how much participants consume while watching a television show. Participants will be randomized to 1 of 3 groups: 1) calorie labels (control); 2) text warning labels; or 3) graphic warning labels displaying amounts of sugar.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medical Ethics & Health Policy

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

March 11, 2020

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations