Front-of-package Marketing on Fruit Drinks: Online RCT

July 26, 2021 updated by: Eric B. Rimm, Harvard School of Public Health (HSPH)

Testing the Impact of Front-of-package Claims, Imagery, Nutrition Disclosures, and Added Sugar Warning Labels on Fruit Drinks in an Online Store: A Randomized Controlled Trial

This study will test the independent and combined effects of front-of-package claims, imagery, nutrition disclosures, and added sugar warning labels on parents' purchases and perceptions of beverages for their children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fruit drinks are widely consumed by 0-5-year-olds. Parents purchase these drinks for their children in part due to misperceptions that they are healthful, which may be driven by front-of-package (FOP) marketing. The FDA is considering changes to FOP marketing regulations but lacks data on how label elements influence consumer behavior. Our study will test the independent and combined effects of FOP claims, imagery, nutrition disclosures, and added sugar warning labels on parents' purchases and perceptions of beverages for their children.

We will conduct an online randomized controlled trial with 5,000 racially/ethnically diverse primary caregivers of children aged 0-5 years. Participants will choose a beverage for their child in an online store and rate health perceptions of different fruit drinks. Participants will be randomized to see high-added-sugar beverages (>20% DV added sugar/serving) with 1 of 7 FOP label conditions: 1) vitamin C claim and fruit imagery (control); 2) imagery only; 3) claim only; 4) no claim or imagery; 5) claim, imagery, and % juice disclosure; 6) claim, imagery, and added sugar warning; or 7) claim, imagery, and added sugar warning w/teaspoons of added sugar.

Primary outcomes will include total calories and added sugar (grams) from chosen online store beverages. Secondary outcomes will include health perceptions and knowledge of added sugar and % juice content in low- and high-added-sugar fruit drinks.

This research will inform federal regulation to correct health misperceptions of sugary drinks.

Study Type

Interventional

Enrollment (Actual)

5028

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Online Recruitment, run via Harvard T.H. Chan School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary caregiver of a child 0-5 years old
  • >= 18 years old
  • U.S. citizen

Exclusion Criteria:

  • Participants who complete the survey in less than 1/3 of the median completion time
  • Observations from duplicate IP addresses (keep first observation that is unique)
  • Participants who answer data integrity check incorrectly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: claim and imagery
control condition (status quo) showing a front-of-package (FOP) vitamin C claim and fruit imagery on all fruit-flavored drinks.
Behavioral: front-of-package modification
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
Experimental: imagery only
FOP fruit imagery on all fruit-flavored drinks, no vitamin C claim on drinks high in added sugars (>=20 %DV)
Behavioral: front-of-package modification
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
Experimental: claim only
FOP vitamin C claim on all fruit-flavored drinks, no fruit imagery on drinks high in added sugars
Behavioral: front-of-package modification
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
Experimental: no claim or imagery
No FOP vitamin C claim or fruit imagery on drinks high in added sugars
Behavioral: front-of-package modification
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
Experimental: claim, imagery, and % juice disclosure
FOP fruit imagery, vitamin C claim, and % juice disclosure on all fruit-flavored drinks
Behavioral: front-of-package modification
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
Experimental: claim, imagery, and added sugar warning
FOP fruit imagery and vitamin C claim on all fruit-flavored drinks; added sugar warning on drinks high in added sugar
Behavioral: front-of-package modification
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
Experimental: claim, imagery, and added sugar warning with teaspoons of added sugar disclosure
FOP fruit imagery and vitamin C claim on all fruit-flavored drinks; added sugar warning with teaspoons of added sugar disclosure on drinks high in added sugar
Behavioral: front-of-package modification
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calories in beverage chosen in online store task
Time Frame: through study completion, an average of 15 minutes
Calories in beverage chosen in online store task
through study completion, an average of 15 minutes
Added sugar content (grams) of beverage chosen in online store task
Time Frame: through study completion, an average of 15 minutes
Added sugar content (grams) of beverage chosen in online store task
through study completion, an average of 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants that chose a drink high in added sugars in online store task
Time Frame: through study completion, an average of 15 minutes
Percentage of participants that chose a drink high in added sugars (>=20%DV) in online store task
through study completion, an average of 15 minutes
Percentage of participants that chose each drink category in online store task
Time Frame: through study completion, an average of 15 minutes
Percentage of participants that chose each drink category (e.g., 100% juice, fruit drinks) in online store task
through study completion, an average of 15 minutes
Fruit drink perceptions: likelihood to purchase for child, how healthy for child, how appealing to child, disease risk perceptions for child
Time Frame: through study completion, an average of 15 minutes
Fruit drink perceptions: likelihood to purchase for child, how healthy for child, how appealing to child, disease risk perceptions for child
through study completion, an average of 15 minutes
Knowledge of juice and added sugar content in beverage
Time Frame: through study completion, an average of 15 minutes
Knowledge of % juice and added sugar content (categorical and continuous in grams) in beverage
through study completion, an average of 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Eric Rimm, ScD, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Actual)

July 21, 2021

Study Completion (Actual)

July 21, 2021

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 76336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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