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ObesityNCT03648138

Testing the Influence of Different Sugary Drink Warning Label Designs

A study testing Sugary drink warning labels in people with Obesity and Weight Gain, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Weight Gain, Diabetes Type 2
What is being tested?
Sugary drink warning labels
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,016 participants
Where
1 siteUnited States
Study dates
17 Jan 2020to 28 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • a primary caregiver of a child 6-to-11 years old;
  • ≥18 years old; and
  • can read and speak English

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Online study with GfK

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Being tested
Sugary drink warning labels
Medical subject headings
Obesity, Weight Gain, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sugary drink warning labelsBehavioural

    This information appears in the description of the study arms.

Study groups in NCT03648138
Study groupRoleWhat they receive
Calorie labelActive comparatorThis 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).
Receives: Behavioral: Sugary drink warning labels
Text warning labelExperimentalThis 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.
Receives: Behavioral: Sugary drink warning labels
Sugar graphic warning labelExperimentalThis 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.
Receives: Behavioral: Sugary drink warning labels
Health graphic warning labelExperimentalThis 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.
Receives: Behavioral: Sugary drink warning labels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypothetical beverage choice

    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

    Measured: The survey will take up to 20 minutes

Secondary outcomes (13)
  1. Likely to serve or buy these beverages:

    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.

    Measured: The survey will take up to 20 minutes

  2. Parent feels good serving the beverages

    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.

    Measured: The survey will take up to 20 minutes

  3. Child enjoyment of beverages

    Item: "How much do you think your child would enjoy this product?" This will be answered on a 7-point likert scale.

    Measured: The survey will take up to 20 minutes

  4. Health beliefs and risk perceptions index

    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.

    Measured: The survey will take up to 20 minutes

  5. Estimate of how many teaspoons of added sugar are in the beverages

    This variable will be measured continuously based on a text box provided to participants.

    Measured: The survey will take up to 20 minutes

  6. Perceived amount of added sugar in beverages

    This variable will be measured on a 3-point Likert scale ranging from "too little for my child" to "too much for my child".

    Measured: The survey will take up to 20 minutes

  7. Noticing the label

    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?"

    Measured: The survey will take up to 20 minutes

  8. Perceived label influence

    Participants will respond: "yes", "no," or "I did not notice any labels" in response to the question of whether the label influenced their purchase.

    Measured: The survey will take up to 20 minutes

  9. Favor or oppose sugary drink warning label policy

    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.

    Measured: The survey will take up to 20 minutes

  10. Likelihood of label changing thoughts

    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.

    Measured: The survey will take up to 20 minutes

  11. Encourage you to give fewer beverages to your child

    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.

    Measured: The survey will take up to 20 minutes

  12. How much do you trust the information on this label

    Item: "How much do you trust the information on this label?". Responses will be measured on a 7-point Likert scale.

    Measured: The survey will take up to 20 minutes

  13. Negative reactions to the label

    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.

    Measured: The survey will take up to 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start17 Jan 2020
  3. Primary completion28 Jan 2020
  4. Study completion28 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,016 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03648138
Sponsor's protocol ID
828087
Other IDs
R01DK111558
Status last verified
Mar 2020
First submitted
7 Aug 2018
Last updated
11 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share a de-identified dataset via an online data storage website (e.g., open science framework, dataverse, research box)

Publications

  • Musicus AA, Gibson LA, Bellamy SL, Orr JA, Hammond D, Glanz K, Volpp KG, Schwartz MB, Bleakley A, Strasser AA, Roberto CA. Effects of Sugary Beverage Text and Pictorial Warnings: A Randomized Trial. Am J Prev Med. 2023 May;64(5):716-727. doi: 10.1016/j.amepre.2023.01.018. Epub 2023 Feb 8.

    PubMed 36764835

Questions about this trial

What is this clinical trial studying?

A study testing Sugary drink warning labels in people with Obesity and Weight Gain, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypothetical beverage choice (time frame: The survey will take up to 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03648138, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.

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