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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03654586
Other study ID # 1R01DK111558-01A1
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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