- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648138
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1016
Phase
- 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
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Online study with GfK
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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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a primary caregiver of a child 6-to-11 years old;
- ≥18 years old; and
- can read and speak English
Exclusion Criteria:
- not a primary caregiver of a child 6-to-11 years old;
- <18 years old; and
- 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 |
Intervention / Treatment |
---|---|
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).
|
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.
|
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.
|
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.
|
This information appears in the description of the study arms.
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What is the study measuring?
Primary Outcome Measures
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
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?"
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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
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Encourage you to give fewer beverages to your child
Time Frame: The survey will take up to 20 minutes
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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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 17, 2020
Primary Completion (ACTUAL)
January 28, 2020
Study Completion (ACTUAL)
January 28, 2020
Study Registration Dates
First Submitted
August 7, 2018
First Submitted That Met QC Criteria
August 24, 2018
First Posted (ACTUAL)
August 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 10, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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