Consumer BehaviorNCT04811690
Front-of-package Marketing on Fruit Drinks: Online RCT
A study testing front-of-package modification in people with Consumer Behavior and Consumer Preference, run by Harvard School of Public Health (HSPH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Consumer Behavior, Consumer Preference
- What is being tested?
- front-of-package modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,028 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 21 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary caregiver of a child 0-5 years old
- >= 18 years old
- U.S. citizen
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Online Recruitment, run via Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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.
- Conditions
- Consumer Behavior, Consumer Preference
- Being tested
- front-of-package modification
- Medical subject headings
- Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
front-of-package modificationBehavioural
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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 Receives: Behavioral: front-of-package modification |
| no claim or imagery | Experimental | No FOP vitamin C claim or fruit imagery on drinks high in added sugars Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: front-of-package modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories in beverage chosen in online store task
Calories in beverage chosen in online store task
Measured: 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
Measured: 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
Percentage of participants that chose a drink high in added sugars (>=20%DV) in online store task
Measured: through study completion, an average of 15 minutes
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
Measured: 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
Fruit drink perceptions: likelihood to purchase for child, how healthy for child, how appealing to child, disease risk perceptions for child
Measured: through study completion, an average of 15 minutes
Knowledge of juice and added sugar content in beverage
Knowledge of % juice and added sugar content (categorical and continuous in grams) in beverage
Measured: through study completion, an average of 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start19 May 2021
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Consumer BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Eric B. Rimm, Harvard School of Public Health (HSPH)
- Investigators
- Eric Rimm, ScD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811690
- Sponsor's protocol ID
- 76336
- Status last verified
- Jul 2021
- First submitted
- 18 Mar 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36227595
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04811690
- Acronym / sponsor ID
- 76336
- Conditions
- Consumer Behavior, Consumer Preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,028 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 19 May 2021 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| claim and imagery | Experimental | Behavioral: front-of-package modificationcontrol condition (status quo) showing a front-of-package (FOP) vitamin C claim and fruit imagery on all fruit-flavored drinks. |
| imagery only | Experimental | Behavioral: front-of-package modificationFOP fruit imagery on all fruit-flavored drinks, no vitamin C claim on drinks high in added sugars (>=20 %DV) |
| claim only | Experimental | Behavioral: front-of-package modificationFOP vitamin C claim on all fruit-flavored drinks, no fruit imagery on drinks high in added sugars |
| no claim or imagery | Experimental | Behavioral: front-of-package modificationNo FOP vitamin C claim or fruit imagery on drinks high in added sugars |
| claim, imagery, and % juice disclosure | Experimental | Behavioral: front-of-package modificationFOP fruit imagery, vitamin C claim, and % juice disclosure on all fruit-flavored drinks |
| claim, imagery, and added sugar warning | Experimental | Behavioral: front-of-package modificationFOP fruit imagery and vitamin C claim on all fruit-flavored drinks; added sugar warning on drinks high in added sugar |
| claim, imagery, and added sugar warning with teaspoons of added sugar disclosure | Experimental | Behavioral: front-of-package modificationFOP 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary caregiver of a child 0-5 years old
- >= 18 years old
- U.S. citizen
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| front-of-package modificationtesting front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks | Behavioural | claim and imagery, claim only, claim, imagery, and % juice disclosure, claim, imagery, and added sugar warning, claim, imagery, and added sugar warning with teaspoons of added sugar disclosure, imagery only, no claim or imagery |
Primary outcome
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
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
4 secondary outcomes
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 each drink category in online store task
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
Time frame: through study completion, an average of 15 minutes
Knowledge of juice and added sugar content in beverage
Time frame: through study completion, an average of 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 36227595Musicus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Rimm, ScD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing front-of-package modification in people with Consumer Behavior and Consumer Preference, run by Harvard School of Public Health (HSPH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calories in beverage chosen in online store task (time frame: through study completion, an average of 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04811690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.