- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00994487
Breastfeeding in Infancy and Food Intake in Preschool-Aged Children
Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Research reports that children who were breastfed as infants have a decreased risk of becoming obese. However, it is not clear how breastfeeding may prevent the development of obesity. Breastfeeding may support the maintenance of sensitivity to internal hunger/fullness cues, which helps with self-regulating energy intake. Additionally, breastfeeding may facilitate the development of a parental feeding style low in control or restriction. This type of feeding style is also associated with greater ability to self-regulate energy intake. Bottle-feeding shifts feeding control to parents, and may lead to a parental feeding style high in control or restriction, impairing children's self-regulation abilities.
The aims of this study are to determine in females aged 3-5 years if: 1.) breastfed children have greater energy self- regulation capabilities; 2.) parents of breastfed children demonstrate a parental feeding style characterized by less control or restriction; and 3.) children with the greatest energy self-regulation capabilities were breastfed and have parents with feeding styles lowest in control or restriction. It is hypothesized that female, preschool-aged children breastfed and/or parented with a feeding style low in control or restriction self-regulate intake better than females not breastfed and/or parented with a feeding style high in control or restriction.
A within-subjects, counterbalanced design, using a standard preloading paradigm, will measure children's ability to self-regulate intake to preloads of differing energy densities. Children and a parent will participate in two trials, with children consuming preloads high and low in energy followed by a lunch in which energy intake is measured. Lunch will be videotaped so parental feeding style during the child's lunch can be coded for restriction and control. Results will provide information about potential mechanisms by which breastfeeding reduces the risk of obesity and obesity related diseases in children.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37996
- University of Tennessee
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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:
Children will be eligible for study participation if they meet the following criteria:
- female
- BMI between the 5th and the 85th percentile
- were of normal birth weight (>2500 g)
- full-term
- have no chronic disease conditions effecting growth and intake
- have not been in foster care for longer than one month (if at all)
- are between 3 and 5 years of age
- are willing to consume and are not allergic to the preloads and meals used in the study
- are not lactose-intolerant
- have a parent who is able to recall mode of feeding in infancy and was either exclusively breast-fed from birth to 3 months of age (defined as being fed from a bottle on average < 1 time per week from birth to 3 months of age, with all other feedings from the breast) or was exclusively bottle-fed from birth to 3 months of age (defined as being completely bottle-fed, with feedings comprised of formula and/or breastmilk)
- have a parent willing to transport child to the University of Tennessee lab at two different times during their participation in the project
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Breastfed child
Female, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age
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Each child with a parent will attend a lunch session.
In these sessions children will drink a liquid preload that is high in energy density and then they will consume an ad libitum lunch.
The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles
Each child with a parent will attend a lunch session.
In these sessions children will drink a liquid preload that is low in energy density and then they will consume an ad libitum lunch.
The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles.
|
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Comparador activo: Bottle Fed Child
Female, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age
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Each child with a parent will attend a lunch session.
In these sessions children will drink a liquid preload that is high in energy density and then they will consume an ad libitum lunch.
The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles
Each child with a parent will attend a lunch session.
In these sessions children will drink a liquid preload that is low in energy density and then they will consume an ad libitum lunch.
The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Compensation for high energy density and low energy density preloads
Periodo de tiempo: 2 days
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2 days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Parental feeding style
Periodo de tiempo: 2 days
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2 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hollie A Raynor, PhD, University of Tennessee
- Silla de estudio: Katie Kavanagh, PhD, Univerisity of Tennessee
- Silla de estudio: Hiliary Fouts, PhD, University of Tennessee
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 7828B
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