- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04259385
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
Terminated
Conditions
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
Interventional
Enrollment (Actual)
1
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
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels
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.
|
Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels
Calories for sugar-sweetened and non-sugar-sweetened beverages
|
What is the study measuring?
Primary Outcome Measures
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
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
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.
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)
March 11, 2020
Primary Completion (Actual)
March 12, 2020
Study Completion (Actual)
March 12, 2020
Study Registration Dates
First Submitted
February 4, 2020
First Submitted That Met QC Criteria
February 4, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Actual)
September 20, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID 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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