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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04811690
Other study ID # 76336
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 19, 2021
Est. completion date July 21, 2021

Study information

Verified date July 2021
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5028
Est. completion date July 21, 2021
Est. primary completion date July 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
front-of-package modification
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks

Locations

Country Name City State
United States Online Recruitment, run via Harvard T.H. Chan School of Public Health Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Harvard School of Public Health Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Calories in beverage chosen in online store task Calories in beverage chosen in online store task through study completion, an average of 15 minutes
Primary Added sugar content (grams) of beverage chosen in online store task Added sugar content (grams) of beverage chosen in online store task through study completion, an average of 15 minutes
Secondary Percentage of participants that chose a drink high in added sugars in online store task 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
Secondary Percentage of participants that chose each drink category in online store task 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
Secondary Fruit drink perceptions: likelihood to purchase for child, how healthy for child, how appealing to child, disease risk perceptions for child 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
Secondary Knowledge of juice and added sugar content in beverage Knowledge of % juice and added sugar content (categorical and continuous in grams) in beverage through study completion, an average of 15 minutes
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