Effects of Sugary Drink Warning Labels on Parent Choices

September 13, 2021 updated by: Christina Roberto, PHD, University of Pennsylvania

Effects of Sugary Drink Warning Labels on Parent Choices for 6-11 Year Olds

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this proposal is to determine, before wide-scale implementation, to what degree SSB warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB intake. The study is designed to answer two additional questions: 1) Do some warning labels work better than others? 3) If warning labels influence behavior, is it because they increase knowledge or simply provide a salient reminder that some drinks are less healthy? This aim is designed to test the effect of warning labels on total kilocalories (kcals) purchased and consumed by parents and children. We will examine how SSB warning labels influence snack and beverage purchases and intake among 405 racially and ethnically diverse parent-child pairs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Calorie/Control Label Condition
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
Calories for sugar-sweetened and non-sugar-sweetened beverages
Experimental: Text Warning Label Condition
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 labels
Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels
Behavioral: Exposure to beverage calorie information
Calories for sugar-sweetened and non-sugar-sweetened beverages
Experimental: Sugar Graphic Label Condition
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 labels
Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels
Behavioral: Exposure to beverage calorie information
Calories for sugar-sweetened and non-sugar-sweetened beverages

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total beverage calories purchased for the child
Time Frame: Study visit, one hour
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
Time Frame: Study visit, one hour
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
Time Frame: Study visit, one hour
Total number of calories consumed by the child for all food and beverages (summed) during the study visit
Study visit, one hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total beverage calories purchased for the adult
Time Frame: Study visit, one hour
Total number of calories for all beverages purchased for the adult during the study visit
Study visit, one hour
Total calories purchased for the adult
Time Frame: Study visit, one hour
Total number of calories for all food and beverages (summed) purchased for the adult during the study visit
Study visit, one hour
Beverage calories the child consumes
Time Frame: Study visit, one hour
Total number of calories consumed by the child for all beverages during the study visit
Study visit, one hour
Beverage calories the adult consumes
Time Frame: Study visit, one hour
Total number of calories consumed by the adult for all beverages during the study visit
Study visit, one hour
Total calories the adult consumes
Time Frame: Study visit, one hour
Total number of calories consumed by the adult for all food and beverages (summed) during the study visit
Study visit, one hour

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent sugary beverage purchase intentions for the child
Time Frame: Study visit, 1 hour
Average of intentions for 4 sugary beverages (1 (not at all likely) - 5 (extremely likely))
Study visit, 1 hour
Parent non-sugary beverage purchase intentions for the child
Time Frame: Study visit, 1 hour
Average of intentions for 3 non-sugary beverages (1 (not at all likely) - 5 (extremely likely))
Study visit, 1 hour
Sugary beverage health beliefs and risk perceptions for the child
Time Frame: Study visit, 1 hour
Average of 9 summed items for 4 sugary beverages (1 (strongly disagree) - 5 (strongly agree))
Study visit, 1 hour
Non-sugary beverage health beliefs and risk perceptions for the child
Time Frame: Study visit, 1 hour
Average of 9 summed items for 3 non-sugary beverages (1 (strongly disagree) - 5 (agree))
Study visit, 1 hour
Sugary beverage accuracy of calorie knowledge
Time Frame: Study visit, 1 hour
Average of difference between actual calories in each item from the calories reported by participants across 4 sugary beverages (larger numbers = overestimation)
Study visit, 1 hour
Non-sugary beverage accuracy of calorie knowledge
Time Frame: Study visit, 1 hour
Average of difference between actual calories in each item from the calories reported by participants across 3 non-sugary beverages (larger numbers = overestimation)
Study visit, 1 hour
Sugary beverage accuracy of sugar knowledge
Time Frame: Study visit, 1 hour
Average of difference between actual teaspoons of sugar in each item from the number of teaspoons reported by participants across 4 sugary beverages (larger numbers = overestimation)
Study visit, 1 hour
Non-sugary beverage accuracy of sugar knowledge
Time Frame: Study visit, 1 hour
Average of difference between actual teaspoons of sugar in each item from the number of teaspoons reported by participants across 3 non-sugary beverages (larger numbers = overestimation)
Study visit, 1 hour
Sugary beverage categorical perception of amount of sugar
Time Frame: Study visit, 1 hour
Proportion of 4 sugary beverages coded as just right or too much vs. none or too little
Study visit, 1 hour
Non-sugary beverage categorical perception of amount of sugar
Time Frame: Study visit, 1 hour
Proportion of 3 non-sugary beverages coded as none vs. all other options
Study visit, 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New York University
University of Connecticut
University of Delaware
Drexel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DK111558_2
  • R01DK111558 (U.S. NIH Grant/Contract)
  • 33648 (Registry Identifier: AsPredicted)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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