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Clinical Trials/NCT04811690
NCT04811690CompletedNot Applicable

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

Harvard School of Public Health (HSPH)2 sites in 1 country5,028 target enrollmentStarted: May 19, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
5,028
Locations
2
Primary Endpoint
Added sugar content (grams) of beverage chosen in online store task

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Percentage of participants that chose each drink category in online store task(through study completion, an average of 15 minutes)
  • Percentage of participants that chose a drink high in added sugars 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(through study completion, an average of 15 minutes)
  • Knowledge of juice and added sugar content in beverage(through study completion, an average of 15 minutes)

Investigators

Sponsor
Harvard School of Public Health (HSPH)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eric B. Rimm

Professor of Nutrition and Epidemiology

Harvard School of Public Health (HSPH)

Study Sites (2)

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