- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
7 de enero de 2021 actualizado por: Kathleen Loralee Keller, Penn State University
Understanding Decision-Making and the Relationship to Food Intake in Children 7 to 11 Years Old
The purpose of this 18-month project is to investigate how decision-making influences food choice and consumption in children ages 7 to 11 years old.
Although several studies suggest that the ability to make good decisions relates to eating behaviors, no studies have looked at how food reward influences the decision-making process to impact actual food intake.
This proposal will answer these questions and bridge this gap in knowledge, which could lead to the development of more effective interventions for childhood obesity.
To accomplish this, the investigators have assembled a diverse team with expertise in food intake, nutrition, and decision sciences.
First, the investigators will establish if there are differences in decision-making between children varying in weight status.
Second, the investigators will determine if performance on behavioral decision-making tasks relates to food consumption in the laboratory.
Third, the investigators will examine response functional magnetic resonance imaging (fMRI) blood-oxygen-level-dependent (BOLD) response to various rewards (i.e.
food and money) and determine if this is influenced by child weight status.
Fourth, the investigators will examine differences in fMRI BOLD at rest in decision-making regions are correlated with food intake and weight status.
Eighty-two children will participate in our study.
The long-term goal of this project is to investigate if there are differences in brain regions corresponding to these behaviors in overweight children and if these differences relate to eating behaviors in this population.
Children will undergo fMRI while playing a reward task as well as consume meals in our laboratory.
Decision-making will also be assessed by having children complete various behavioral measurements of reward and inhibitory control.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
142
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pennsylvania
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University Park, Pennsylvania, Estados Unidos, 16802
- The Pennsylvania State University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
7 años a 11 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Children aged 7-11 years old.
Descripción
Inclusion Criteria:
- Right-handed
- English as native language
- Reading at/above grade level
- Not Claustrophobic
- Generally Healthy
Exclusion Criteria:
- Left-handedness
- Metal in or on body that cannot be removed
- Claustrophobia
- Medication usage that may alter brain activity or blood flow
- Medical disorder that may impact comfort of safety in MRI scanner
- Food Allergies
- Dietary Restrictions
- Learning Disabilities
- Psychiatric Disorders
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Periodo de tiempo: Collected at fMRI scan at week 4
|
Regions of interest BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at fMRI scan at week 4
|
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Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at rest (resting-state fMRI)
Periodo de tiempo: Collected at fMRI scan at week 4
|
Regions of interest BOLD analysis of resting-state fMRI to examine differences in brain regions of interest at rest
|
Collected at fMRI scan at week 4
|
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Behavioral inhibitory control task
Periodo de tiempo: Collected at either week 1-3 (randomized)
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Measured by performance on a go/nogo task
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Collected at either week 1-3 (randomized)
|
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Behavioral reward inhibitory control task
Periodo de tiempo: Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
|
Measured by performance on a go/nogo task with a reward incentive
|
Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
|
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Behavioral risk-taking and reward task
Periodo de tiempo: Collected at either week 1-3 (randomized)
|
Measured by performance on the hungry donkey task
|
Collected at either week 1-3 (randomized)
|
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Behavioral dietary self-control assessment
Periodo de tiempo: Collected at either week 1-3 (randomized)
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Measured by performance on a dietary self-control task
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Collected at either week 1-3 (randomized)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Energy intake at baseline
Periodo de tiempo: Collected at either week 1-3 (randomized)
|
Measured at an objective laboratory test-meal (kcal and grams)
|
Collected at either week 1-3 (randomized)
|
|
Energy intake at a buffet meal
Periodo de tiempo: Collected at either week 1-3 (randomized)
|
Measured at an objective laboratory test-meal (kcal and grams)
|
Collected at either week 1-3 (randomized)
|
|
Energy intake after a meal preload
Periodo de tiempo: Collected at either week 1-3 (randomized) following the baseline meal
|
Measured at an objective laboratory test-meal (kcal and grams)
|
Collected at either week 1-3 (randomized) following the baseline meal
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Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Periodo de tiempo: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at baseline
Periodo de tiempo: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Altura
Periodo de tiempo: Recolectado en la semana 1
|
Altura en cm medida por estadiómetro
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Recolectado en la semana 1
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Porcentaje de grasa corporal
Periodo de tiempo: Recolectado en la semana 1
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Evaluado por escala de análisis de impedancia bioeléctrica
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Recolectado en la semana 1
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Rasgos apetitivos
Periodo de tiempo: Recolectado en la semana 1
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Cuestionario informado por los padres sobre estilos de alimentación habituales en niños
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Recolectado en la semana 1
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Liking of foods
Periodo de tiempo: Collected after each meal at multiple time points during weeks 1-4
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Ratings of how much the child likes each food in the meal on a visual analog scale
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Collected after each meal at multiple time points during weeks 1-4
|
|
Fullness feelings
Periodo de tiempo: Collected at multiple time points during weeks 1-4
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Ratings of how full the child feels measured on a child-friendly visual analog scale
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Collected at multiple time points during weeks 1-4
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Pubertal Development
Periodo de tiempo: Collected at week 1
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Child report of pubertal status questionnaire
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Collected at week 1
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Weight
Periodo de tiempo: Collected at week 1
|
Weight in kg measured by a standard digital scale
|
Collected at week 1
|
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Body mass index
Periodo de tiempo: Collected at week 1
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Calculated from height, age, sex
|
Collected at week 1
|
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BMI percentile
Periodo de tiempo: Collected at week 1
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Calculated from height, weight, age and sex - according to the Center for Disease Control (CDC) standards
|
Collected at week 1
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BMI z-score
Periodo de tiempo: Collected at week 1
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Calculated from height, weight, age and sex - according to CDC standards
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Collected at week 1
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Fat mass index
Periodo de tiempo: Collected at week 1
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Calculated from height, weight, age, sex
|
Collected at week 1
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Fat-free mass index
Periodo de tiempo: Collected at week 1
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Calculated from height, weight, age, sex
|
Collected at week 1
|
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Parental feeding strategies
Periodo de tiempo: Collected at week 1
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Parent-reported questionnaire of feeding practices
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Collected at week 1
|
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Family demographics
Periodo de tiempo: Collected at week 1
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Parent-report questionnaire
|
Collected at week 1
|
|
Loss of control eating
Periodo de tiempo: Collected at week 4
|
Loss of control when eating is frequently reported in middle childhood.
Loss of control when eating was assessed via interview-style questionnaire to determine pre-clinical binge-like eating behaviors that may influence the primary outcome of energy intake at the 4 conditions of test-meals.
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Collected at week 4
|
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Inhibitory control and reward sensitivity questionnaires
Periodo de tiempo: Collected on either week 1-3 (randomized)
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Parent and child report of inhibitory control and reward sensitivity on a questionnaire
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Collected on either week 1-3 (randomized)
|
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Age
Periodo de tiempo: Collected at the week 1
|
Age of participant
|
Collected at the week 1
|
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Sex
Periodo de tiempo: collected at week 1
|
sex of participant
|
collected at week 1
|
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Parent height
Periodo de tiempo: collected at week 1
|
height in cm of parent measured by a stadiometer
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collected at week 1
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Parent weight
Periodo de tiempo: collected at week 1
|
weight in kg of parent measured by a standard digital scale
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collected at week 1
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parent body fat
Periodo de tiempo: collected at week 1
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measured by bioelectrical impedance
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collected at week 1
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Puberty Assessment Parental Report
Periodo de tiempo: Collected at week 1
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Parent report of pubertal status questionnaire
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Collected at week 1
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Shana Adise, B.S., The Pennsylvania State University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Adise S, White CN, Roberts NJ, Geier CF, Keller KL. Children's inhibitory control abilities in the presence of rewards are related to weight status and eating in the absence of hunger. Appetite. 2021 Dec 1;167:105610. doi: 10.1016/j.appet.2021.105610. Epub 2021 Jul 26.
- Adise S, Geier CF, Roberts NJ, White CN, Keller KL. Is brain response to food rewards related to overeating? A test of the reward surfeit model of overeating in children. Appetite. 2018 Sep 1;128:167-179. doi: 10.1016/j.appet.2018.06.014. Epub 2018 Jun 8.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2015
Finalización primaria (Actual)
1 de octubre de 2016
Finalización del estudio (Actual)
1 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
29 de junio de 2016
Primero enviado que cumplió con los criterios de control de calidad
3 de agosto de 2016
Publicado por primera vez (Estimar)
4 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
7 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DecisionMakingEatingKids01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .