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

Sponsor
Harvard School of Public Health (HSPH) (Other)
Overall Status
Completed
CT.gov ID
NCT04811690
Collaborator
Robert Wood Johnson Foundation (Other)
5,028
1
7
2.1
2429.2

Study Details

Study Description

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
  • Behavioral: front-of-package modification
N/A

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
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 :
Jul 21, 2021
Actual Study Completion Date :
Jul 21, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Calories in beverage chosen in online store task [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 [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 [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 [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 [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 [through study completion, an average of 15 minutes]

    Knowledge of % juice and added sugar content (categorical and continuous in grams) in beverage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Mar 23, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 28, 2021