Effects of Sugary Drink Warning Labels

NCT03654586 | Terminated DMC

• 1 other identifier: 1R01DK111558-01A1
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes; Weight Gain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (26)

• Noticing the calorie label

  These will be assessed at one time point at the end of the 6-week study

• Perceived calorie label influence

  These will be assessed at one time point at the end of the 6-week study

• Noticing the warning label

  These will be assessed at one time point at the end of the 6-week study

• Perceived warning label influence

  These will be assessed at one time point at the end of the 6-week study

• Label message recall

  These will be assessed at one time point at the end of the 6-week study

Study Arms (4)

Calorie label

ACTIVE COMPARATOR

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

Text warning label

EXPERIMENTAL

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

Sugar graphic warning label

EXPERIMENTAL

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

Health graphic warning label

EXPERIMENTAL

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

Interventions

Sugary drink warning labels BEHAVIORAL

The description of each intervention appears in the descriptions of the experimental arms.

Calorie label; Health graphic warning label; Sugar graphic warning label; Text warning label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Drexel University: collaborator
• New York University: collaborator
• University of Connecticut: collaborator

Study Sites (1)

Blockley Hall

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• Christina A Roberto, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Ethics and Health Policy

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 31, 2018
• Study Start: July 30, 2018
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be made available soon after the paper is published in a peer-reviewed journal.
• Access Criteria: All researchers will be able to access the data

Locations

US (1)