Testing the Influence of Different Sugary Drink Warning Label Designs

March 10, 2020 updated by: Christina Roberto, University of Pennsylvania
The aim of this study is to compare different sugary drink labels to see which most influence knowledge, beliefs, purchase intentions and choices. Parents of children ages 6-11 will shop in a virtual convenience store after being randomized to 1 of 4 conditions: 1) calorie labels; 2) text warning labels; 3) graphic sugar warning labels; or 4) graphic health warning. This study will provide data comparing the influence of sugary drink text warning labels and two kinds of graphic warning labels.

Study Overview

Status

Status

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

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.

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.
1016

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
        • Online study with GfK

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. a primary caregiver of a child 6-to-11 years old;
  2. ≥18 years old; and
  3. can read and speak English

Exclusion Criteria:

  1. not a primary caregiver of a child 6-to-11 years old;
  2. <18 years old; and
  3. cannot read and/or speak English

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: FACTORIAL
  • Masking: NONE

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 label
This arm will display a "Calories per Bottle" label on all beverages, not just sugary beverages. This label is identical to the American Beverage Association's current "Clear on Calories" labels (as of 2018).
Behavioral: Sugary drink warning labels
This information appears in the description of the study arms.
EXPERIMENTAL: Text warning label
This arm will display similar text proposed in a recent sugary drink warning label bill in California. Sample text: WARNING: Drinking beverages with added sugar(s) contributes to obesity, type 2 diabetes, and tooth decay. The calorie label will also appear on all beverages.
Behavioral: Sugary drink warning labels
This information appears in the description of the study arms.
EXPERIMENTAL: Sugar graphic warning label
This arm will graphically display the amount of sugar in each sugary beverage along with the same text used in the "text warning label" arm. The calorie label will also appear on all beverages.
Behavioral: Sugary drink warning labels
This information appears in the description of the study arms.
EXPERIMENTAL: Health graphic warning label
This arm will graphically display potential negative health effects of over consuming sugary drinks for each sugary beverage, along with the same text used in the "text warning label" arm. The calorie label will also appear on all beverages.
Behavioral: Sugary drink warning labels
This information appears in the description of the study arms.

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
Hypothetical beverage choice
Time Frame: The survey will take up to 20 minutes
Participants will select a beverage to purchase in the virtual store. Our outcome will be the percentage of parents choosing a 20-ounce sugary drink for their child
The survey will take up to 20 minutes

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
Likely to serve or buy these beverages:
Time Frame: The survey will take up to 20 minutes
Item: "How likely are you to serve or buy this product for your child in the next 4 weeks?" This will be answered on a 7-point Likert scale.
The survey will take up to 20 minutes
Parent feels good serving the beverages
Time Frame: The survey will take up to 20 minutes
Item: "Serving this product to my child would make me feel like I am doing something good for my child." This will be measured on a 7-point likert scale.
The survey will take up to 20 minutes
Child enjoyment of beverages
Time Frame: The survey will take up to 20 minutes
Item: "How much do you think your child would enjoy this product?" This will be answered on a 7-point likert scale.
The survey will take up to 20 minutes
Health beliefs and risk perceptions index
Time Frame: The survey will take up to 20 minutes
We will create this outcome by summing responses to the following 7 health perception questions 6 prompted with the statement "Drinking this product often would…". The statements end with the following health belief and risk perception language: "lead my child to gain weight," "increase my child's risk of heart disease," "increase my child's risk of diabetes," "make my child feel energized," "help my child focus at school", and "help my child live a healthy life." The other item is: "How healthy do you think this product is for your child?" Responses to questions about weight gain, heart disease, and diabetes will be reverse coded, so higher scores on the index will indicate a stronger positive health perception of the beverages. These will be scored on 7-point likert scales.
The survey will take up to 20 minutes
Estimate of how many teaspoons of added sugar are in the beverages
Time Frame: The survey will take up to 20 minutes
This variable will be measured continuously based on a text box provided to participants.
The survey will take up to 20 minutes
Perceived amount of added sugar in beverages
Time Frame: The survey will take up to 20 minutes
This variable will be measured on a 3-point Likert scale ranging from "too little for my child" to "too much for my child".
The survey will take up to 20 minutes
Noticing the label
Time Frame: The survey will take up to 20 minutes
Participants will respond "yes," "no," or "I don't know" to the item: "When you selected a beverage to buy for your child at the beginning of this survey, did you notice any labels on the beverages other than calorie information?"
The survey will take up to 20 minutes
Perceived label influence
Time Frame: The survey will take up to 20 minutes
Participants will respond: "yes", "no," or "I did not notice any labels" in response to the question of whether the label influenced their purchase.
The survey will take up to 20 minutes
Favor or oppose sugary drink warning label policy
Time Frame: The survey will take up to 20 minutes
We will compare the percentage of participants in favor of (combining somewhat favor and strongly favor), opposed to (combining somewhat oppose and strongly oppose), or neutral about the policy based on the following question: "Would you favor or oppose a government policy requiring a warning label to be placed on beverages with added sugars?" Ratings will be from -2 to 2.
The survey will take up to 20 minutes
Likelihood of label changing thoughts
Time Frame: The survey will take up to 20 minutes
Item: "If this government warning label were on a beverage, how much would it change your thoughts about the healthiness of that beverage for your child?" This will be measured on a 5-point Likert scale.
The survey will take up to 20 minutes
Encourage you to give fewer beverages to your child
Time Frame: The survey will take up to 20 minutes
Item: "If you saw this government warning label on a beverage, would the label encourage you to serve your child that beverage less often?" The responses will be measured on a 5-point Likert scale.
The survey will take up to 20 minutes
How much do you trust the information on this label
Time Frame: The survey will take up to 20 minutes
Item: "How much do you trust the information on this label?". Responses will be measured on a 7-point Likert scale.
The survey will take up to 20 minutes
Negative reactions to the label
Time Frame: The survey will take up to 20 minutes
We will examine the average negative emotional response to the label (said the warning label made them feel worried, fearful, guilty, or disgusted or grossed out). Each emotion will be scored on a 5-pt likert scale.
The survey will take up to 20 minutes

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
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.
January 17, 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.
January 28, 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.
January 28, 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).
August 7, 2018

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.
August 24, 2018

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.
August 27, 2018

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.
March 11, 2020

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.
March 10, 2020

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.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 828087
  • R01DK111558 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share a de-identified dataset via an online data storage website (e.g., open science framework, dataverse, research box)

IPD Sharing Time Frame

The data will be made available soon after the paper is published in a peer-reviewed journal.

IPD Sharing Access Criteria

All researchers will be able to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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.

Clinical Trials on Obesity

Clinical Trials on Sugary drink warning labels

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings