- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01982279
Longitudinal Measurement of Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
One Year Change in Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices.
Three series of measurements of caloric compensation (CC) and eating in the absence of hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of measurement was composed of three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Dijon, Francia, 21000
- Centre des Sciences du Goût et de l'Alimentation
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- To be registered to the school canteen, to provide parental approval at inclusion and at the FU15M
Exclusion Criteria:
- Chronic disease or food allergies
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Transversal
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in caloric compensation in 15 months
Periodo de tiempo: one week
|
To evaluate the change in caloric compensation across time, caloric compensation was measured at baseline, 3 and 15 months after baseline, in the same conditions.
At each time point to assess caloric compensation, children were offered a chocolate bun 30 minutes before the lunch.
The food intake at lunch was recorded.
We calculated if children compensated the chocolate bun, by comparing energy intake at this lunch with energy intake from a control lunch which took place one week before.
|
one week
|
Control measurement of energy intake at baseline
Periodo de tiempo: One week
|
We conducted a control lunch and recorded food intake of each child.
This measurement was conducted a week before measuring caloric compensation.
|
One week
|
Change in eating in the absence of hunger in 15 months
Periodo de tiempo: one week.
|
In order to evaluate the change in eating in the absence of hunger across time, a measurement was conducted at baseline, 3 months and 15 months after baseline.
To collect the measurement of eating in the absence of hunger, we offered palatable foods to children 10 minutes after their lunch.
We recorded the energy intake from these post-meal foods.
At each time point, this measurement was conducted one week after the measurement of caloric compensation.
|
one week.
|
Control measurement of energy intake three months after baseline
Periodo de tiempo: One week
|
We conducted a control lunch and recorded food intake of each child.
This measurement was conducted a week before measuring caloric compensation.
|
One week
|
Control measurement of energy intake fifteen months after baseline
Periodo de tiempo: One week
|
We conducted a control lunch and recorded food intake of each child.
This measurement was conducted a week before measuring caloric compensation.
|
One week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maternal feeding practices and eating behavior
Periodo de tiempo: one month after inclusion
|
Using a validated questionnaire, we collected information about maternal feeding practices (Comprehensive Feeding Practices Questionnaire, Musher-Eizenman & Holub, 2007) and eating behaviour (Dutch Eating Behaviour Questionnaire, Van Strien, 1986).
|
one month after inclusion
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nicklaus Sophie, phD, Centre des Sciences du Goût et de l'Alimentation
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HabEat WP31 Follow up
- INRA WP31 FU
- WP31.FU. INRA (Otro identificador: INRA)
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.
producto fabricado y exportado desde los 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. .