Effects of Sugary Drink Warning Labels

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Obesity, Diabetes, Weight Gain

Intervention / Treatment
-----------------
* Behavioral: Sugary drink warning labels


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: There was no answer option for our study design, but factorial is most similar. Participants will be randomly assigned to one of four conditions described below. 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. Text warning labels will display the following text on sugary beverages: WARNING: drinking beverages with added sugars contributes to obesity, diabetes, and tooth decay Sugar graphic warning labels will display the same text as text warning labels along with graphics depicting the amount of sugar in the beverage 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calorie label<br>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. | Behavioral: Sugary drink warning labels<br>* The description of each intervention appears in the descriptions of the experimental arms.<br>|
| Experimental: Text warning label<br>Text warning labels will display the following text on sugary beverages: WARNING: drinking beverages with added sugars contributes to obesity, diabetes, and tooth decay | Behavioral: Sugary drink warning labels<br>* The description of each intervention appears in the descriptions of the experimental arms.<br>|
| Experimental: Sugar graphic warning label<br>Sugar graphic warning labels will display the same text as text warning labels along with graphics depicting the amount of sugar in the beverage | Behavioral: Sugary drink warning labels<br>* The description of each intervention appears in the descriptions of the experimental arms.<br>|
| Experimental: Health graphic warning label<br>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. | Behavioral: Sugary drink warning labels<br>* The description of each intervention appears in the descriptions of the experimental arms.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total calories purchased | total calories purchased over four weeks in an online store. | four weeks | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |