- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03654586
Effects of Sugary Drink Warning Labels
April 20, 2021 updated by: Christina Roberto, PHD, University of Pennsylvania
A Randomized-controlled Experiment on the Effects of Sugary Drink Warning Labels
The primary objective of this study is to determine to what degree sugary drink warning labels increase consumers' knowledge about the potential health harms of sugary drinks and reduce sugary drink intake.
The study is designed to answer three additional questions: 1) Do some warning labels work better than others?
2) What is the effect of warning labels over time? 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 study will test the effect of repeated exposure to warning labels on total calories purchased over time and assess whether knowledge or salience better explain label effects.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
337
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, 19103
- Blockley Hall
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: Participants must:
- be a primary caregiver of a child under 12 years old;
- be ≥18 years old;
- read and speak English;
- drink sugary drinks at least twelve times per month (~three times per week) and have a child who does the same
- be the primary grocery shopper for their family;
- have regular internet access.
Exclusion Criteria:
- not a primary caregiver of a child under 12 years old
- <18 years old
- cannot read and speak English
- does not drink sugary drinks at least 12 times per month and have a child who does the same
- is not the primary grocery shopper for their family
- does not have regular internet access
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
Calorie label (control) will display a "Calories per Bottle" label on all beverages, not just sugary drinks.
This is modeled after the American Beverage Association's current "Clear on Calories" labels.
|
The description of each intervention appears in the descriptions of the experimental arms.
|
EXPERIMENTAL: Text warning label
Text warning labels will display the following text on sugary beverages: WARNING: drinking beverages with added sugars contributes to obesity, diabetes, and tooth decay
|
The description of each intervention appears in the descriptions of the experimental arms.
|
EXPERIMENTAL: Sugar graphic warning label
Sugar graphic warning labels will display the same text as "text warning labels" along with graphics depicting the amount of sugar in the beverage
|
The description of each intervention appears in the descriptions of the experimental arms.
|
EXPERIMENTAL: Health graphic warning label
Health graphic warning label will display the same text as "text warning labels" along with graphics depicting the potential negative health consequences of over-consuming sugary drinks.
|
The description of each intervention appears in the descriptions of the experimental arms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total calories purchased
Time Frame: four weeks
|
total calories purchased over four weeks in an online store.
|
four weeks
|
Total calories purchased in last two weeks of study
Time Frame: six weeks
|
total calories purchased in the last two weeks of the study, after the labels are removed from the store.
|
six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Noticing the calorie label
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
We will compare the percentage reporting "yes," "no," or "I don't know" to the question: "When you were buying beverages in the online store, did you notice any calorie labels next to the beverages?"
|
These will be assessed at one time point at the end of the 6-week study
|
Perceived calorie label influence
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
We will compare the percent responding "yes", "no," or "I did not notice any labels" in response to the question of whether the calorie label influenced their purchase.
|
These will be assessed at one time point at the end of the 6-week study
|
Noticing the warning label
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
We will compare the percent responding "yes", "no," or "I did not notice any labels" in response to the question, "When you were buying beverages in the online store, did you notice any warning labels next to the beverages?"
|
These will be assessed at one time point at the end of the 6-week study
|
Perceived warning label influence
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
We will compare the percent responding "yes", "no," or "I did not notice any labels" in response to the question of whether the warning label influenced their purchase.
|
These will be assessed at one time point at the end of the 6-week study
|
Label message recall
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
Participants will be prompted to remember the message on the warning labels in response to the following question: "If you saw warning labels, please type what you think the label said in the text box below."
If participants cannot remember what the label said, they will be encouraged to respond with their best guess.
If participants believe they did not see a label, they will be instructed to respond with "I did not see a warning label."
We will examine the percent correctly recalling the label message.
|
These will be assessed at one time point at the end of the 6-week study
|
Likelihood of buying the beverage
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
Item: "How likely are you to buy this beverage in the next 4 weeks?"
Responses will be measured on a 5-point Likert scale ranging from 'Not at all' to 'Extremely'.
|
These will be assessed at one time point at the end of the 6-week study
|
Parent affect around serving non-sugary beverages
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' affect toward serving their child non-sugary beverages.
We will create this outcome by averaging responses to the following two questions separately for all non-sugary beverages: "Serving this beverage to my child would make me feel like a good parent" AND "Serving this beverage to my child would make me feel like I am doing something good for my child."
These will be measured on 5-point Likert scales.
The average non-sugary response for each participant will yield a scale ranging 1 (worse outcome) to 5 (better outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Parent affect around serving sugary beverages
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' affect toward serving their child sugary beverages.
We will create this outcome by averaging responses to the following two questions separately for all sugary beverages: "Serving this beverage to my child would make me feel like a good parent" AND "Serving this beverage to my child would make me feel like I am doing something good for my child."
These will be measured on 5-point Likert scales.
The average sugary response for each participant will yield a scale ranging 1 (better outcome) to 5 (worse outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Enjoyment of non-sugary beverages
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' enjoyment of non-sugary beverages.
We will create this outcome by averaging responses to "How delicious is this beverage?"
separately for all non-sugary beverages.
These will be measured on 5-point Likert scales.
The average non-sugary response for each participant will yield a scale ranging 1 (worse outcome) to 5 (better outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Enjoyment of sugary beverages
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' enjoyment of sugary beverages.
We will create this outcome by averaging responses to "How delicious is this beverage?"
separately for all sugary beverages.
These will be measured on 5-point Likert scales.
The average sugary response for each participant will yield a scale ranging 1 (better outcome) to 5 (worse outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Healthiness of non-sugary beverages
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' belief in the healthiness of non-sugary beverages.
We will create this outcome by averaging responses to "How healthy is this beverage?"
separately for all non-sugary beverages.
These will be measured on 5-point Likert scales.
The average non-sugary response for each participant will yield a scale ranging 1 (worse outcome) to 5 (better outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Healthiness of sugary beverages
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' belief in the healthiness of sugary beverages.
We will create this outcome by averaging responses to "How healthy is this beverage?"
separately for all sugary beverages.
These will be measured on 5-point Likert scales.
The average sugary response for each participant will yield a scale ranging 1 (better outcome) to 5 (worse outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Non-sugary beverage influence on child's energy and focus
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' belief that drinking non-sugary beverages improves their child's energy and focus.
We will create this outcome by averaging responses to the following two questions separately for all non-sugary beverages: "Drinking this beverage often would make my child feel energized" and "Drinking this product often would help my child focus at school."
These will be measured on 5-point Likert scales.
The average non-sugary response for each participant will yield a scale ranging 1 (worse outcome) to 5 (better outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Sugary beverage influence on child's energy and focus
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' belief that drinking sugary beverages improves their child's energy and focus.
We will create this outcome by averaging responses to the following two questions separately for all sugary beverages: "Drinking this beverage often would make my child feel energized" and "Drinking this product often would help my child focus at school."
These will be measured on 5-point Likert scales.
The average sugary response for each participant will yield a scale ranging 1 (better outcome) to 5 (worse outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Non-sugary drink health beliefs and risk perceptions index
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' health beliefs and risk perceptions about their child's drinking non-sugary beverages.
We will create this outcome by averaging the responses to the following health perception questions prompted with the statement "If my child drank this beverage often it would…" across all non-sugary beverages.
The statements end with the following health belief and risk perception language: "cause 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 non-sugary beverages.
All variables will be measured on a 5-point Likert scale.
The average non-sugary response for each participant will yield a scale ranging 1 (worse outcome) to 5 (better outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Sugary drink health beliefs and risk perceptions index
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This scale measures parents' health beliefs and risk perceptions about their child's drinking sugary beverages.
We will create this outcome by averaging the responses to the following health perception questions prompted with the statement "If my child drank this beverage often it would…" across all sugary beverages.
The statements end with the following health belief and risk perception language: "cause 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 sugary beverages.
All variables will be measured on a 5-point Likert scale.
The average sugary response for each participant will yield a scale ranging 1 (better outcome) to 5 (worse outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Estimate of calories per non-sugary drink bottle
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This variable will be the average across all responses to non-sugary beverages measured continuously based on open-ended text box provided to participants.
Responses will be limited to a maximum of 4-digits.
Numbers closer to the true average will be the better outcome.
|
These will be assessed at one time point at the end of the 6-week study
|
Estimate of calories per sugary drink bottle
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This variable will be the average across all responses to sugary beverages measured continuously based on open-ended text box provided to participants.
Responses will be limited to a maximum of 4-digits.
Numbers closer to the true average will be the better outcome.
|
These will be assessed at one time point at the end of the 6-week study
|
Estimate of teaspoons of added sugar per non-sugary drink bottle
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This variable will be an average across all non-sugary beverages of a 4-point Likert scale ranging from 'None' (1; better outcome) to 'A lot' (4; worse outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Estimate of teaspoons of added sugar per sugary drink bottle
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
This variable will be an average across all sugary beverages of a 4-point Likert scale ranging from 'None' (1; worse outcome) to 'A lot' (4; better outcome).
|
These will be assessed at one time point at the end of the 6-week study
|
Perceived amount of sugar
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
Item: "Do you think this amount of sugar for your child is…?"
This variable will be measured on a 3-point Likert scale ranging from "too little" (1; worse outcome) to "too much" (3; better outcome)
|
These will be assessed at one time point at the end of the 6-week study
|
Label trust
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
Item: "How much do you trust the information on this label?".
Responses will be measured on a 5-point Likert scale.
|
These will be assessed at one time point at the end of the 6-week study
|
Label purchase influence
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
Item: "When you saw this label next to an item in the store, to what extent were you less or more likely to buy the item?"
The responses will be measured on a 5-point Likert scale.
|
These will be assessed at one time point at the end of the 6-week study
|
Positive and negative reactions to the label
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
We will compare 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 hopeful or happy.
We will average across these ratings and define this as an average score >3 on a 1-5 Likert scale)
|
These will be assessed at one time point at the end of the 6-week study
|
Negative reactions to the label
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
We will compare 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 depressed, fearful, guilty, discouraged, annoyed, scared, disgusted or grossed out, sad, angry, or afraid.
We will average across these ratings and define this as an average score >3 on a 1-5 Likert scale)
|
These will be assessed at one time point at the end of the 6-week study
|
Newest vital sign measure
Time Frame: These will be assessed at one time point at the end of the 6-week study
|
Participants will be shown a nutrition label and asked to answer some questions that will require them to read and understand the information presented on the label.
This is a publically available, validated assessment.
We will examine this as a moderator of label effects.
|
These will be assessed at one time point at the end of the 6-week study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 30, 2018
Primary Completion (ACTUAL)
March 12, 2020
Study Completion (ACTUAL)
March 12, 2020
Study Registration Dates
First Submitted
August 7, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (ACTUAL)
August 31, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 23, 2021
Last Update Submitted That Met QC Criteria
April 20, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DK111558-01A1 (NIH)
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
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Sugary drink warning labels
-
University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); New... and other collaboratorsCompletedObesity | Weight Gain | Diabetes Type 2United States
-
University of North Carolina, Chapel HillStanford UniversityCompletedWeight StigmaUnited States
-
University of North Carolina, Chapel HillThe Bloomberg Family Foundation, Inc.CompletedDietary ExposureUnited States
-
Duke-NUS Graduate Medical SchoolWorld Bank; Public Health Authority of Saudi ArabiaCompleted
-
University of California, San DiegoNot yet recruitingE Cigarette Use
-
Abramson Cancer Center of the University of PennsylvaniaNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI); Wellcome Trust; University...Completed
-
Georgetown UniversityCompleted
-
University of California, DavisActive, not recruitingAttitude | IntentionUnited States
-
Instituto Nacional de Salud Publica, MexicoCompleted