Online Study of the Effects of Sugary Drink Warning Labels on Consumption

March 6, 2024 updated by: University of Pennsylvania

Communicating the Health Risks of Sugar-Sweetened Beverages: A Randomized-controlled Experiment of Different Nutrition Labels on Purchases and Consumption

The aim of this study is to determine the degree to which sugar-sweetened beverages (SSB) warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB purchases and consumption. 216 racially and ethnically diverse parents of children 6-11 years old will be recruited to buy snacks and beverages for four weeks via an online store that ships participants their purchases. Participants will be randomized to either 1) calorie labels (control); or 2) sugar graphic warning labels. The investigators hypothesize that sugar graphic warning labels displayed in an online store in weeks 2-4 will lead to the greatest reductions from week 1 across both primary outcomes compared to the control group that will only see calorie labels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During this study, participants will shop in an online store created using Shopify for four weeks. In this within-participant design, the first week of shopping is baseline. Participants will then be randomized to different store interfaces for the remaining three weeks based on one of two warning label conditions: 1) calorie labels (control); or 2) sugar graphic warning labels. Participants will complete a brief survey at the start of the study to assess demographic information, information about parent and child beverage consumption, and their online shopping experiences. At the end they will complete another survey about their beverage consumption, their experience shopping in the store, whether they noticed and used the warning labels, and their ability to recall the warning label message. Participants will also be asked about their perceptions of a specific type of warning label in this final survey. Upon completion of the survey, participants will be shown a debriefing statement explaining the study purpose. After they read the information, they will be asked whether or not they consent to allow their data to be used in this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • a primary caregiver of a child 6-to-11 years old;
  • >=18 years old;
  • can read and speak English;
  • primary grocery shopper for their household;
  • have regular Internet access; and
  • report that the oldest of their children between 6 and 11 years old is consuming sugar sweetened beverages at least twelve times per month or approximately three times a week

Exclusion Criteria:

  • not a primary caregiver of a child 6-to-11 years old;
  • <18 years old;
  • cannot read and/or speak English;
  • not the primary grocery shopper for their household;
  • does not have regular Internet access; and
  • does not report that the oldest of their children between 6 and 11 years old is consuming sugar sweetened beverages at least twelve times per month or approximately three times a week

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Calorie label
Calorie label (control) will display a calories per package label on all beverages, not just sugary drinks. This is modeled after the American Beverage Association's current "Clear on Calories" labels. Additionally, all snack items will have a calories per serving label.
Behavioral: Exposure to calorie information
Calories for all beverages and foods
Experimental: Sugar graphic warning label
All products in this arm will also have calorie labels. Beverages with added sugar will also have sugar graphic warning labels with the text: "WARNING: drinking beverages with added sugars contributes to obesity, diabetes, and tooth decay" along with graphics depicting the amount of sugar in the beverage.
Behavioral: Exposure to calorie information
Calories for all beverages and foods
Behavioral: Exposure to sugar-sweetened beverage warning labels
Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Beverage Calories Purchased, Week 1
Time Frame: one week
Logged beverage calories/100mL purchased. Number of servings per item and number of items per package varied by product; therefore, calorie amounts were standardized to calories/100mL for beverages.
one week
Beverage Calories Purchased, Weeks 2-4
Time Frame: three weeks
Logged average beverage calories/100mL purchased per week over Weeks 2-4. Number of servings per item and number of items per package varied by product; therefore, calorie amounts were standardized to calories/100mL for beverages.
three weeks
Beverage Added Sugars Purchased, Week 1
Time Frame: one week
Beverage grams of added sugars/100mL purchased. Number of servings per item and number of items per package varied by product; therefore, added sugar amounts were standardized to grams of added sugar/100mL for beverages.
one week
Beverage Added Sugars Purchased, Weeks 2-4
Time Frame: three weeks
Average beverage grams of added sugars/100mL purchased per week over Weeks 2-4. Number of servings per item and number of items per package varied by product; therefore, added sugar amounts were standardized to grams of added sugar/100mL for beverages.
three weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number Purchasing a Sweetened Beverage, Week 1
Time Frame: one week
Number of parents buying a sweetened beverage within each condition
one week
Number Purchasing a Sweetened Beverage, Weeks 2-4
Time Frame: three weeks
Number of parents buying a sweetened beverage at any point during Weeks 2-4, within each condition
three weeks
Snack Calories Purchased, Week 1
Time Frame: one week
Logged snack calories/100g purchased. Number of servings per item and number of items per package varied by product; therefore, calorie amounts were standardized to calories/100g for snacks.
one week
Snack Calories Purchased, Weeks 2-4
Time Frame: three weeks
Logged average snack calories/100g purchased per week over Weeks 2-4. Number of servings per item and number of items per package varied by product; therefore, calorie amounts were standardized to calories/100g for snacks.
three weeks
Snack Added Sugars Purchased, Week 1
Time Frame: one week
Snack grams of added sugars/100g purchased. Number of servings per item and number of items per package varied by product; therefore, added sugar amounts were standardized to grams of added sugar/100g for snacks.
one week
Snack Added Sugars Purchased, Weeks 2-4
Time Frame: three weeks
Average snack grams of added sugars/100g purchased per week over Weeks 2-4. Number of servings per item and number of items per package varied by product; therefore, added sugar amounts were standardized to grams of added sugar/100g for snacks.
three weeks
Total Calories Purchased, Week 1
Time Frame: one week
Log of the summed beverage and snack calories purchased
one week
Total Calories Purchased, Weeks 2-4
Time Frame: three weeks
Log of the average summed beverage and snack calories purchased per week over Weeks 2-4
three weeks
Total Added Sugars Purchased, Week 1
Time Frame: one week
Summed grams of beverage and snack added sugars purchased
one week
Total Added Sugars Purchased, Weeks 2-4
Time Frame: three weeks
Average summed grams of beverage and snack added sugars purchased per week over Weeks 2-4
three weeks
Volume of Sweetened Beverages Consumed by Child, Baseline
Time Frame: baseline
Ounces of sweetened beverages (labeled in sugar condition) consumed per day in the last month by the child as measured by the Beverage Intake Questionnaire (BEV-Q) parent self-report survey.
baseline
Volume of Sweetened Beverages Consumed by Child, Final
Time Frame: Week 4
Ounces of sweetened beverages (labeled in sugar condition) consumed per day in the last month by the child as measured by the Beverage Intake Questionnaire (BEV-Q) parent self-report survey.
Week 4
Volume of Sweetened Beverages Consumed by Parent, Baseline
Time Frame: baseline
Ounces of sweetened beverages (labeled in sugar condition) consumed per day in the last month by the parent as measured by the Beverage Intake Questionnaire (BEV-Q) self-report survey.
baseline
Volume of Sweetened Beverages Consumed by Parent, Final
Time Frame: Week 4
Ounces of sweetened beverages (labeled in sugar condition) consumed per day in the last month by the parent as measured by the Beverage Intake Questionnaire (BEV-Q) self-report survey.
Week 4
Noticing the Label
Time Frame: Week 4
Participants will respond "yes," "no," or "I don't know" to the item: "When you selected a beverage to purchase in the store, did you notice any labels on the beverages other than calorie information?"
Week 4
Perceived Label Influence
Time Frame: Week 4
Participants will respond: "yes", "no," or "I did not notice any labels" in response to the question of whether the label influenced their purchase.
Week 4
How Much do You Trust the Information on This Label
Time Frame: Week 4
"How much do you trust the information on this label?". Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater trust in the label.
Week 4
Likelihood of Label Changing Thoughts
Time Frame: Week 4
"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?" Responses will be measured with a 5-point Likert scale where 1=Not at all and 5=A lot. Higher numbers indicate the label would be more likely to change perceptions of beverage healthiness.
Week 4
Encourage You to Give Fewer Beverages to Your Child
Time Frame: Week 4
"If you saw this government warning label on a beverage, would the label encourage you to serve your child that beverage less often?" Responses will be measured with a 5-point Likert scale where 1=Definitely no and 5=Definitely yes. Higher numbers indicate greater likelihood of serving unhealthy beverages less often.
Week 4
Negative Reactions to the Label
Time Frame: Week 4
Average negative emotional response to the label will be examined (said the warning label made them feel worried, fearful, guilty, or disgusted or grossed out). Responses will be measured with a 5-point Likert scale averaging across the 4 negative emotions where 1=Not at all and 5=Extremely. Higher numbers indicate more negative reactions.
Week 4
Child Enjoyment of Water
Time Frame: Week 4
"How much do you think your child would enjoy this product?" Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater enjoyment of the product.
Week 4
Child Enjoyment of Orange Juice
Time Frame: Week 4
"How much do you think your child would enjoy this product?" Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater enjoyment of the product.
Week 4
Child Enjoyment of Soda
Time Frame: Week 4
"How much do you think your child would enjoy this product?" Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater enjoyment of the product.
Week 4
Child Enjoyment of Sports Drink
Time Frame: Week 4
"How much do you think your child would enjoy this product?" Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater enjoyment of the product.
Week 4
Likely to Serve or Buy Water
Time Frame: Week 4
"How likely are you to serve or buy this product for your child in the next 4 weeks?" Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater likelihood of serving or buying the product for their child.
Week 4
Likely to Serve or Buy Orange Juice
Time Frame: Week 4
"How likely are you to serve or buy this product for your child in the next 4 weeks?" Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater likelihood of serving or buying the product for their child.
Week 4
Likely to Serve or Buy Soda
Time Frame: Week 4
"How likely are you to serve or buy this product for your child in the next 4 weeks?" Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater likelihood of serving or buying the product for their child.
Week 4
Likely to Serve or Buy Sports Drinks
Time Frame: Week 4
"How likely are you to serve or buy this product for your child in the next 4 weeks?" Responses will be measured with a 7-point Likert scale where 1=Not at all and 7=Extremely. Higher numbers indicate greater likelihood of serving or buying the product for their child.
Week 4
Health Beliefs and Risk Perceptions Index for Water
Time Frame: Week 4
Summed responses to the following 7 health perception questions, 6 of which are 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 summed index will indicate a stronger positive health perception of the beverages. This index ranges 7 to 49.
Week 4
Health Beliefs and Risk Perceptions Index for Orange Juice
Time Frame: Week 4
Summed responses to the following 7 health perception questions, 6 of which are 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 summed index will indicate a stronger positive health perception of the beverages. This index ranges 7 to 49.
Week 4
Health Beliefs and Risk Perceptions Index for Soda
Time Frame: Week 4
Summed responses to the following 7 health perception questions, 6 of which are 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 summed index will indicate a stronger positive health perception of the beverages. This index ranges 7 to 49.
Week 4
Health Beliefs and Risk Perceptions Index for Sports Drinks
Time Frame: Week 4
Summed responses to the following 7 health perception questions, 6 of which are 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 summed index will indicate a stronger positive health perception of the beverages. This index ranges 7 to 49.
Week 4
Estimate of How Many Teaspoons of Added Sugar Are in Water
Time Frame: Week 4
This variable will be measured continuously based on a text box provided to participants. Median teaspoons in each condition will be assessed
Week 4
Estimate of How Many Teaspoons of Added Sugar Are in Orange Juice
Time Frame: Week 4
This variable will be measured continuously based on a text box provided to participants. Median teaspoons in each condition will be assessed
Week 4
Estimate of How Many Teaspoons of Added Sugar Are in Soda
Time Frame: Week 4
This variable will be measured continuously based on a text box provided to participants. Median teaspoons in each condition will be assessed
Week 4
Estimate of How Many Teaspoons of Added Sugar Are in Sports Drinks
Time Frame: Week 4
This variable will be measured continuously based on a text box provided to participants. Median teaspoons in each condition will be assessed
Week 4
Perceived Amount of Added Sugar in Water
Time Frame: Week 4
This variable will be measured with a 3-point ordinal Likert scale with values: 1 = "too little for my child", 2 = "just right for my child" and 3 = "too much for my child". Higher scores indicate beverage is perceived as having too much added sugar.
Week 4
Perceived Amount of Added Sugar in Orange Juice
Time Frame: Week 4
This variable will be measured with a 3-point ordinal Likert scale with values: 1 = "too little for my child", 2 = "just right for my child" and 3 = "too much for my child". Higher scores indicate beverage is perceived as having too much added sugar.
Week 4
Perceived Amount of Added Sugar in Soda
Time Frame: Week 4
This variable will be measured with a 3-point ordinal Likert scale with values: 1 = "too little for my child", 2 = "just right for my child" and 3 = "too much for my child". Higher scores indicate beverage is perceived as having too much added sugar.
Week 4
Perceived Amount of Added Sugar in Sports Drinks
Time Frame: Week 4
This variable will be measured with a 3-point ordinal Likert scale with values: 1 = "too little for my child", 2 = "just right for my child" and 3 = "too much for my child". Higher scores indicate beverage is perceived as having too much added sugar.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina A Roberto, PhD, University of Pennsylvania

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 844786
  • R01DK111558 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In the consenting process, participants agreed that de-identified data produced from this project may be distributed for future research studies without additional informed consent. Any de-identified data shared will be done so via PennBox, a secure method to transfer files.

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

The PI will review requests to use de-identified study data.

IPD Sharing Supporting Information Type

  • SAP

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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