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

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ClinicalTrials.gov Identifier: NCT04811690
Recruitment Status : Completed
First Posted : March 23, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Eric B. Rimm, Harvard School of Public Health (HSPH)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Consumer Behavior Consumer Preference Behavioral: front-of-package modification Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5028 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 19, 2021
Actual Primary Completion Date : July 21, 2021
Actual Study Completion Date : July 21, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811690


Locations
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United States, Massachusetts
Online Recruitment, run via Harvard T.H. Chan School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Public Health (HSPH)
Robert Wood Johnson Foundation
Investigators
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Principal Investigator: Eric Rimm, ScD Harvard School of Public Health (HSPH)
More Information
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Responsible Party: Eric B. Rimm, Professor of Nutrition and Epidemiology, Harvard School of Public Health (HSPH)
ClinicalTrials.gov Identifier: NCT04811690    
Other Study ID Numbers: 76336
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No