- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Online Recruitment, run via Harvard T.H. Chan School of Public Health
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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)
|
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
|
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
|
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
|
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
|
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
|
testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Calories in beverage chosen in online store task
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of participants that chose a drink high in added sugars in online store task
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eric Rimm, ScD, Harvard School of Public Health (HSPH)
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 76336
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .