Clinical trial NCT03654586: Effects of Sugary Drink Warning Labels
Official title: A Randomized-controlled Experiment on the Effects of Sugary Drink Warning Labels
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Diabetes
Weight Gain
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Drexel University
name: New York University
name: University of Connecticut
First posted: 2018-08-31
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.

1. 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.
2. Text warning labels will display the following text on sugary beverages: WARNING: drinking beverages with added sugars contributes to obesity, diabetes, and tooth decay
3. Sugar graphic warning labels will display the same text as "text warning labels" along with graphics depicting the amount of sugar in the beverage
4. 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Total calories purchased
timeFrame: four weeks
measure: Total calories purchased in last two weeks of study
timeFrame: six weeks
Secondary outcomes:
measure: Noticing the calorie label
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Perceived calorie label influence
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Noticing the warning label
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Perceived warning label influence
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Label message recall
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Likelihood of buying the beverage
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Parent affect around serving non-sugary beverages
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Parent affect around serving sugary beverages
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Enjoyment of non-sugary beverages
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Enjoyment of sugary beverages
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Healthiness of non-sugary beverages
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Healthiness of sugary beverages
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Non-sugary beverage influence on child's energy and focus
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Sugary beverage influence on child's energy and focus
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Non-sugary drink health beliefs and risk perceptions index
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Sugary drink health beliefs and risk perceptions index
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Estimate of calories per non-sugary drink bottle
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Estimate of calories per sugary drink bottle
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Estimate of teaspoons of added sugar per non-sugary drink bottle
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Estimate of teaspoons of added sugar per sugary drink bottle
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Perceived amount of sugar
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Label trust
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Label purchase influence
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Positive and negative reactions to the label
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Negative reactions to the label
timeFrame: These will be assessed at one time point at the end of the 6-week study
measure: Newest vital sign measure
timeFrame: These will be assessed at one time point at the end of the 6-week study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Blockley Hall
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Christina A Roberto, PhD
role: PRINCIPAL_INVESTIGATOR
References: