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Testing the Influence of Different Sugary Drink Warning Label Designs

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ClinicalTrials.gov Identifier: NCT03648138
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Drexel University
New York University
University of Connecticut
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Christina Roberto, University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Weight Gain Diabetes Type 2 Behavioral: Sugary drink warning labels Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Masking Description: Although participants are not blinded to the study arm to which they are randomized, they are not told the true purpose of the study until after completing the study.
Primary Purpose: Prevention
Official Title: Testing the Influence of Different Sugary Drink Warning Label Designs
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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).
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, 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 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.




Primary Outcome Measures :
  1. 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

  2. Beverage coupon [ Time Frame: The survey will take up to 20 minutes ]
    The outcome will be the percentage of parents choosing a discount coupon for a 20-ounce sugary drink.


Secondary Outcome Measures :
  1. 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 drink for your child in the next 4 weeks?" This will be answered on a 7-point Likert scale.

  2. Parent feels good serving the beverages [ Time Frame: The survey will take up to 20 minutes ]
    We will create this outcome by averaging responses to the following two questions: "Serving this drink to my child would make me feel like a good parent" AND "Serving this drink to my child would make me feel like I am doing something good for my child." These will be measured on a 7-point likert scales.

  3. 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 drink?" This will be answered on a 7-point likert scale.

  4. Beverages' influence on child's energy and focus [ Time Frame: The survey will take up to 20 minutes ]
    This variable will be created by averaging responses to the following two statements: "Drinking this beverage often would make my child feel energized" and "Drinking this beverage often would help my child focus at school." These will be measured on 7-point likert scales.

  5. Perceived healthiness of beverages [ Time Frame: The survey will take up to 20 minutes ]
    Item: "How healthy do you think this drink is for your child?." This will be answered on a 7-point likert scale.

  6. 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 health perception questions prompted with the statement "Drinking this beverage 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," "increase my child's risk of cancer," and "help my child live a healthier life." Responses to questions about weight gain, heart disease, diabetes, and cancer 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.

  7. Estimate of how many calories 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.

  8. Estimate of how many teaspoons of 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.

  9. Perceived amount of 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" to "too much".

  10. 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 from the shelf at the beginning of this survey to buy for your child, did you notice any labels next to the beverages?"

  11. 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.

  12. 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.

  13. 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.

  14. Encourage you to give fewer beverages to your child [ Time Frame: The survey will take up to 20 minutes ]
    Item: "If this government warning label were on beverages with a lot of added sugars, would the label encourage you to give fewer of those beverages to your child?" The responses will be measured on a 5-point Likert scale.

  15. 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 5-point Likert scale.

  16. Positive and negative reactions to the label [ Time Frame: The survey will take up to 20 minutes ]
    We will examine the percentage of people that had a predominantly positive reaction to the label (percentage of people that said the warning label predominantly made them feel cheerful, pleased, stimulated, or soothed) and we will examine the percentage of people that had a predominantly negative reaction to the label (percentage of people that said the warning label predominantly made them feel insulted, irritated, or repulsed). Each emotion will be scored on a 5-pt likert scale. We will consider scores of 4 and 5 as reflecting "predominantly positive" or "predominantly negative."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) a primary caregiver of a child 6-to-11 years old; 2) ≥18 years old; 3) can read and speak English; and 4) their child drinks sugary drinks at least twelve times per month (~three times per week).

Exclusion Criteria:

1) not a primary caregiver of a child 6-to-11 years old; 2) <18 years old; 3) cannot read and/or speak English; and 4) their child drinks sugary drinks less than twelve times per month (~three times per week).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648138


Contacts
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Contact: Christina Roberto, PhD 6315138799 croberto@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Online study with GfK Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Makenzie Wood, MSEd    215-898-7547      
Sponsors and Collaborators
University of Pennsylvania
Drexel University
New York University
University of Connecticut
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Christina A Roberto, PhD University of Pennsylvania

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Responsible Party: Christina Roberto, Assistant Professor of Medical Ethics and Health Policy, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03648138     History of Changes
Other Study ID Numbers: 828087
R01DK111558 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share a de-identified dataset via an online data storage website (e.g., open science framework, dataverse, research box)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: The data will be made available soon after the paper is published in a peer-reviewed journal.
Access Criteria: All researchers will be able to access the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases