- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07818382
Assessing the Relationships Between Parent-child Eating in the Absence of Hunger, Appetitive Traits, and Food Parenting.
Eating Together Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Buffalo, New York, Estados Unidos, 14214
- Reclutamiento
- State University of New York at Buffalo (South Campus)
-
Contacto:
- Hannah E Kolpack, BS
- Número de teléfono: 7168295820
- Correo electrónico: hkolpack@buffalo.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Parent/ guardian:
- Age > 18 years old.
- Have a child between the ages of 5 - 11.
- Must be responsible for feeding their eligible child at least 50% of the time.
- Willing and able to eat the meal and snacks provided.
- Fluent in English.
Children:
- If parent/ guardian is eligible and participating in the study.
- Child is aged 5 - 11 years.
- Child is not currently diagnosed with a clinical eating disorder (ED).
- Willing and able to eat the meal and snacks provided.
- Child is not on any medications or has any condition that could influence the child's taste, appetite, or olfactory sensory responsiveness.
Exclusion Criteria:
Parent/ guardian:
- Age is >18 years old.
- Their child is determined ineligible (based on age).
- Is responsible for feeding their eligible child < 50% of the time.
- Not fluent in English.
- On medication that could influence their eating or feeding behaviors.
- If the parent/ guardian is pregnant
- Allergic or unable to eat the study food presented.
- History of choking (without gagging).
Children:
- Their parent/ guardian is not eligible nor participating in the study.
- Below the age of 5 and above the age of 11.
- Current diagnosis of a clinical eating disorder (ED).
- Allergic or unable to eat the study food presented.
- Medications or conditions that could influence the child's taste, appetite, or olfactory sensory responsiveness.
- History of choking (without gagging).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Eating in Absence of Hunger (EAH) paradigm
Participating dyads will be asked to eat until full at a standardized meal while being video and audio recorded.
Dyads will then be separated and undergo a "taste test".
This taste test introduces the EAH paradigm, whereas participants will be presented with 8 different highly palatable snack foods and seated activities.
They are given 15 minutes of free time to eat and/or engage in these activities.
They will be left alone during this time and are informed to not use electronic devices.
Their Eating in Absence of Hunger energy intake will be measured by weighing the remaining snack foods.
Multiple hunger, thirst, and liking forms throughout the paradigm.
The nature of the EAH paradigm is not disclosed until the end of the session, where there is a formal debriefing.
|
Participating dyads will be asked to eat until full at a standardized meal while being video and audio recorded.
Dyads will then be separated and undergo a "taste test".
This taste test introduces the EAH paradigm, whereas participants will be presented with 8 different highly palatable snack foods and seated activities.
They are given 15 minutes of free time to eat and/or engage in these activities.
They will be left alone during this time and are informed to not use electronic devices.
Their Eating in Absence of Hunger energy intake will be measured by weighing the remaining snack foods.
Multiple hunger, thirst, and liking forms throughout the paradigm.
The nature of the EAH paradigm is not disclosed until the end of the session, where there is a formal debriefing.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation between parent EAH intake and child EAH intake
Periodo de tiempo: Up to 120 minutes
|
Parent EAH intake will be measured by weighing the amount of snacks (in kcal) consumed at the parent EAH paradigm (0kcal to 2400kcal). Child EAH intake will be measured by weighing the amount of snacks (in kcal) consumed at the child EAH paradigm (0kcal to 2400kcal). Correlation will be assessed by comparing the parent EAH intake (kcal) and child EAH intake (kcal). If both parent EAH intake (kcal) and child EAH intake (kcal) are high/low, there exists a positive correlation between them. On the other hand, if parent EAH intake (kcal) is high and child EAH intake (kcal) is low or vice versa, there exists a negative correlation between them. |
Up to 120 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation between the parental pressure to eat score and child EAH intake
Periodo de tiempo: Up to 120 minutes
|
Child EAH intake will be measured as the amount of snacks consumed during the EAH paradigm (0-2,400 kcal). Parental pressure to eat score will be assessed using the Pressure to Eat subscale of the Structure and Control in Parent Feeding (SCPF) Questionnaire, with scores ranging from 1-5. Lower scores indicate less parental pressure to eat, while higher scores indicate greater parental pressure to eat. The correlation between child EAH intake and parental pressure to eat score will be assessed. A positive correlation indicates that higher parental pressure to eat score is associated with higher EAH intake, whereas a negative correlation indicates that higher parental pressure to eat score is associated with lower EAH intake. |
Up to 120 minutes
|
|
Correlation between the parental restriction score and child EAH intake
Periodo de tiempo: Up to 120 minutes
|
Child EAH intake will be measured as the amount of snacks consumed during the EAH paradigm (0-2,400 kcal). Parental restriction score will be assessed using the restriction subscale of the Structure and Control in Parent Feeding (SCPF) Questionnaire, with scores ranging from 1-5. Lower scores indicate less parental restriction, while higher scores indicate greater parental restriction. The correlation between child EAH intake and parental restriction score will be assessed. A positive correlation indicates that higher parental restriction score is associated with higher EAH intake, whereas a negative correlation indicates that higher parental restricton score is associated with lower EAH intake. |
Up to 120 minutes
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Katherine N Balantekin, PhD, RD, University at Buffalo
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00010477
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.
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