Effects of Sugary Drink Warning Labels

Obesity Clinical Trial

Official title:

A Randomized-controlled Experiment on the Effects of Sugary Drink Warning Labels

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03654586
• Other study ID #: 1R01DK111558-01A1
• Status: Terminated
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: March 12, 2020

Study information

• Verified date: April 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 337
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Weight Gain

Intervention

Behavioral:
• Sugary drink warning labels
The description of each intervention appears in the descriptions of the experimental arms.

Locations

Country	Name	City	State
United States	Blockley Hall	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Drexel University, New York University, University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total calories purchased	total calories purchased over four weeks in an online store.	four weeks
Primary	Total calories purchased in last two weeks of study	total calories purchased in the last two weeks of the study, after the labels are removed from the store.	six weeks
Secondary	Noticing the calorie label	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
Secondary	Perceived calorie label influence	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
Secondary	Noticing the warning label	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
Secondary	Perceived warning label influence	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
Secondary	Label message recall	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
Secondary	Likelihood of buying the beverage	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
Secondary	Parent affect around serving non-sugary beverages	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
Secondary	Parent affect around serving sugary beverages	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
Secondary	Enjoyment of non-sugary beverages	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
Secondary	Enjoyment of sugary beverages	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
Secondary	Healthiness of non-sugary beverages	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
Secondary	Healthiness of sugary beverages	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
Secondary	Non-sugary beverage influence on child's energy and focus	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
Secondary	Sugary beverage influence on child's energy and focus	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
Secondary	Non-sugary drink health beliefs and risk perceptions index	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
Secondary	Sugary drink health beliefs and risk perceptions index	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
Secondary	Estimate of calories per non-sugary drink bottle	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
Secondary	Estimate of calories per sugary drink bottle	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
Secondary	Estimate of teaspoons of added sugar per non-sugary drink bottle	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
Secondary	Estimate of teaspoons of added sugar per sugary drink bottle	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
Secondary	Perceived amount of sugar	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
Secondary	Label trust	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
Secondary	Label purchase influence	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
Secondary	Positive and negative reactions to the label	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
Secondary	Negative reactions to the label	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
Secondary	Newest vital sign measure	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