- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04811690
Front-of-package Marketing on Fruit Drinks: Online RCT
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Online Recruitment, run via Harvard T.H. Chan School of Public Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: claim and imagery
control condition (status quo) showing a front-of-package (FOP) vitamin C claim and fruit imagery on all fruit-flavored drinks.
|
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
|
|
Eksperimentell: imagery only
FOP fruit imagery on all fruit-flavored drinks, no vitamin C claim on drinks high in added sugars (>=20 %DV)
|
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
|
|
Eksperimentell: claim only
FOP vitamin C claim on all fruit-flavored drinks, no fruit imagery on drinks high in added sugars
|
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
|
|
Eksperimentell: no claim or imagery
No FOP vitamin C claim or fruit imagery on drinks high in added sugars
|
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
|
|
Eksperimentell: claim, imagery, and % juice disclosure
FOP fruit imagery, vitamin C claim, and % juice disclosure on all fruit-flavored drinks
|
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
|
|
Eksperimentell: 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
|
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
|
|
Eksperimentell: 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
|
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Calories in beverage chosen in online store task
Tidsramme: through study completion, an average of 15 minutes
|
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
Tidsramme: through study completion, an average of 15 minutes
|
Added sugar content (grams) of beverage chosen in online store task
|
through study completion, an average of 15 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants that chose a drink high in added sugars in online store task
Tidsramme: 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
|
through study completion, an average of 15 minutes
|
|
Percentage of participants that chose each drink category in online store task
Tidsramme: 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
|
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
Tidsramme: 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
Tidsramme: through study completion, an average of 15 minutes
|
Knowledge of % juice and added sugar content (categorical and continuous in grams) in beverage
|
through study completion, an average of 15 minutes
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Eric Rimm, ScD, Harvard School of Public Health (HSPH)
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 76336
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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