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- Ensayo clínico NCT03892733
Improving the Impact of Calorie Labeling Policies
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
By the year 2030, 50% of American adults could be obese. Increasingly, Americans are consuming more foods away from home and most of these foods are consumed in fast-food restaurants. Menu calorie labeling provides calorie information at the point of purchase in fast-food restaurants and is one strategy employed to promote lower calorie, healthier food choices. Initial studies of the impact of calorie labeling, however, suggest that posting calories may only affect calories purchased in a minority of consumers.
The Patient Protection and Affordable Care Act (PPACA) mandates that calorie labeling be implemented nationally and fast-food restaurants throughout the U.S. will begin to post calorie information. With an overarching goal of improving the impact of calorie labeling policies; this proposal will develop and pilot test a brief intervention that is complementary to the posted calorie information, and will explore potential barriers to reducing calories among an urban clinic population. The study aims are: (Aim 1) To develop the Complementary Calorie Labeling (CCL) intervention, an individual single-session intervention that can be delivered in primary care settings. Semi-structured interviews will be conducted among 40 overweight or obese participants to guide development of intervention components and materials. (Aim 2) To conduct a pilot randomized controlled trial of the CCL intervention among 188 overweight or obese participants. The CCL intervention will be compared to a control group that receives an educational brochure about calories. The primary outcome will be weekly calories purchased at fast-food restaurants as measured by fast-food receipts and food logs. (Aim 3) To examine whether calorie knowledge, health literacy, numeracy, and motivation are barriers to using calorie information and whether these variables moderate intervention efficacy.
The proposed study will be conducted in a primarily low-income, minority clinic population in the Bronx NYC. NYC was the first major city to implement calorie labeling. Preliminary data from NYC suggest that fast-food consumers in the Bronx may be less likely to reduce their calories purchased when calorie information is posted, compared to other consumers in NYC. Developing interventions that may improve the impact of calorie labeling policies within this population will have important implications as these policies are implemented in urban communities throughout the U.S.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Eats at Fast-food restaurant at least once per week BMI>25
Exclusion Criteria:
- inability to keep food logs or fast-food receipts
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention
CHEKS (calorie health, education, knowledge and skills) intervention will educate participants about calories in fast-food and teach skills to select lower calorie fast-food items.
|
45 minute intervention done by health educator to give participants skills to use calorie information posted in fast-food restaurants
|
Sin intervención: Control
Participants will receive a brochure about healthier choices in fast-food restaurants.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
fast-food calories per week
Periodo de tiempo: 4 weeks
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change in fast-food calories purchased
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4 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nichola Davis, NYC Health + Hospitals
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
- 2011-579
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. .