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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05079477
Other study ID # 844786
Secondary ID R01DK111558
Status Completed
Phase N/A
First received
Last updated
Start date October 6, 2021
Est. completion date January 17, 2023

Study information

Verified date March 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date January 17, 2023
Est. primary completion date January 17, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Exposure to calorie information
Calories for all beverages and foods

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Beverage Calories Purchased, Week 1 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
Primary Beverage Calories Purchased, Weeks 2-4 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
Primary Beverage Added Sugars Purchased, Week 1 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
Primary Beverage Added Sugars Purchased, Weeks 2-4 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 Number Purchasing a Sweetened Beverage, Week 1 Number of parents buying a sweetened beverage within each condition one week
Secondary Number Purchasing a Sweetened Beverage, Weeks 2-4 Number of parents buying a sweetened beverage at any point during Weeks 2-4, within each condition three weeks
Secondary Snack Calories Purchased, Week 1 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
Secondary Snack Calories Purchased, Weeks 2-4 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
Secondary Snack Added Sugars Purchased, Week 1 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
Secondary Snack Added Sugars Purchased, Weeks 2-4 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
Secondary Total Calories Purchased, Week 1 Log of the summed beverage and snack calories purchased one week
Secondary Total Calories Purchased, Weeks 2-4 Log of the average summed beverage and snack calories purchased per week over Weeks 2-4 three weeks
Secondary Total Added Sugars Purchased, Week 1 Summed grams of beverage and snack added sugars purchased one week
Secondary Total Added Sugars Purchased, Weeks 2-4 Average summed grams of beverage and snack added sugars purchased per week over Weeks 2-4 three weeks
Secondary Volume of Sweetened Beverages Consumed by Child, 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
Secondary Volume of Sweetened Beverages Consumed by Child, Final 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
Secondary Volume of Sweetened Beverages Consumed by Parent, 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
Secondary Volume of Sweetened Beverages Consumed by Parent, Final 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
Secondary Noticing the Label 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
Secondary 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. Week 4
Secondary How Much do You Trust the Information on This Label "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
Secondary Likelihood of Label Changing Thoughts "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
Secondary Encourage You to Give Fewer Beverages to Your Child "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
Secondary Negative Reactions to the Label 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
Secondary Child Enjoyment of Water "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
Secondary Child Enjoyment of Orange Juice "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
Secondary Child Enjoyment of Soda "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
Secondary Child Enjoyment of Sports Drink "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
Secondary Likely to Serve or Buy Water "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
Secondary Likely to Serve or Buy Orange Juice "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
Secondary Likely to Serve or Buy Soda "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
Secondary Likely to Serve or Buy Sports Drinks "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
Secondary Health Beliefs and Risk Perceptions Index for Water 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
Secondary Health Beliefs and Risk Perceptions Index for Orange Juice 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
Secondary Health Beliefs and Risk Perceptions Index for Soda 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
Secondary Health Beliefs and Risk Perceptions Index for Sports Drinks 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
Secondary Estimate of How Many Teaspoons of Added Sugar Are in Water This variable will be measured continuously based on a text box provided to participants. Median teaspoons in each condition will be assessed Week 4
Secondary Estimate of How Many Teaspoons of Added Sugar Are in Orange Juice This variable will be measured continuously based on a text box provided to participants. Median teaspoons in each condition will be assessed Week 4
Secondary Estimate of How Many Teaspoons of Added Sugar Are in Soda This variable will be measured continuously based on a text box provided to participants. Median teaspoons in each condition will be assessed Week 4
Secondary Estimate of How Many Teaspoons of Added Sugar Are in Sports Drinks This variable will be measured continuously based on a text box provided to participants. Median teaspoons in each condition will be assessed Week 4
Secondary Perceived Amount of Added Sugar in Water 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
Secondary Perceived Amount of Added Sugar in Orange Juice 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
Secondary Perceived Amount of Added Sugar in Soda 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
Secondary Perceived Amount of Added Sugar in Sports Drinks 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
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