NCT04811690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,028

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

March 18, 2021

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Calories in beverage chosen in online store task

    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

    Added sugar content (grams) of beverage chosen in online store task

    through study completion, an average of 15 minutes

Secondary Outcomes (4)

  • Percentage of participants that chose a drink high in added sugars in online store task

    through study completion, an average of 15 minutes

  • Percentage of participants that chose each drink category 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

Study Arms (7)

claim and imagery

EXPERIMENTAL

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

imagery only

EXPERIMENTAL

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

claim only

EXPERIMENTAL

FOP vitamin C claim on all fruit-flavored drinks, no fruit imagery on drinks high in added sugars

Behavioral: front-of-package modification

no claim or imagery

EXPERIMENTAL

No FOP vitamin C claim or fruit imagery on drinks high in added sugars

Behavioral: front-of-package modification

claim, imagery, and % juice disclosure

EXPERIMENTAL

FOP fruit imagery, vitamin C claim, and % juice disclosure on all fruit-flavored drinks

Behavioral: front-of-package modification

claim, imagery, and added sugar warning

EXPERIMENTAL

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

claim, imagery, and added sugar warning with teaspoons of added sugar disclosure

EXPERIMENTAL

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

Interventions

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

claim and imageryclaim onlyclaim, imagery, and % juice disclosureclaim, imagery, and added sugar warningclaim, imagery, and added sugar warning with teaspoons of added sugar disclosureimagery onlyno claim or imagery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online Recruitment, run via Harvard T.H. Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Musicus AA, Roberto CA, Moran AJ, Sorscher S, Greenthal E, Rimm EB. Effect of Front-of-Package Information, Fruit Imagery, and High-Added Sugar Warning Labels on Parent Beverage Choices for Children: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236384. doi: 10.1001/jamanetworkopen.2022.36384.

MeSH Terms

Conditions

Consumer Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Eric Rimm, ScD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Epidemiology

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 23, 2021

Study Start

May 19, 2021

Primary Completion

July 21, 2021

Study Completion

July 21, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations