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Decision-Making and the Relationship to Food Intake in Kids (DMK)

7 de janeiro de 2021 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

142

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Pennsylvania
      • University Park, Pennsylvania, Estados Unidos, 16802
        • The Pennsylvania State University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

7 anos a 11 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Children aged 7-11 years old.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Prazo: 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
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at rest (resting-state fMRI)
Prazo: 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
Behavioral inhibitory control task
Prazo: Collected at either week 1-3 (randomized)
Measured by performance on a go/nogo task
Collected at either week 1-3 (randomized)
Behavioral reward inhibitory control task
Prazo: 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)
Behavioral risk-taking and reward task
Prazo: Collected at either week 1-3 (randomized)
Measured by performance on the hungry donkey task
Collected at either week 1-3 (randomized)
Behavioral dietary self-control assessment
Prazo: Collected at either week 1-3 (randomized)
Measured by performance on a dietary self-control task
Collected at either week 1-3 (randomized)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Energy intake at baseline
Prazo: 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
Prazo: 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
Prazo: 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
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Prazo: 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
Prazo: Collected at week 4
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
Collected at week 4

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Altura
Prazo: Coletado na semana 1
Altura em cm medida pelo estadiômetro
Coletado na semana 1
Percentual de gordura corporal
Prazo: Coletado na semana 1
Avaliado por escala de análise de impedância bioelétrica
Coletado na semana 1
Traços apetitosos
Prazo: Coletado na semana 1
Questionário relatado pelos pais sobre estilos alimentares habituais em crianças
Coletado na semana 1
Liking of foods
Prazo: Collected after each meal at multiple time points during weeks 1-4
Ratings of how much the child likes each food in the meal on a visual analog scale
Collected after each meal at multiple time points during weeks 1-4
Fullness feelings
Prazo: Collected at multiple time points during weeks 1-4
Ratings of how full the child feels measured on a child-friendly visual analog scale
Collected at multiple time points during weeks 1-4
Pubertal Development
Prazo: Collected at week 1
Child report of pubertal status questionnaire
Collected at week 1
Weight
Prazo: Collected at week 1
Weight in kg measured by a standard digital scale
Collected at week 1
Body mass index
Prazo: Collected at week 1
Calculated from height, age, sex
Collected at week 1
BMI percentile
Prazo: Collected at week 1
Calculated from height, weight, age and sex - according to the Center for Disease Control (CDC) standards
Collected at week 1
BMI z-score
Prazo: Collected at week 1
Calculated from height, weight, age and sex - according to CDC standards
Collected at week 1
Fat mass index
Prazo: Collected at week 1
Calculated from height, weight, age, sex
Collected at week 1
Fat-free mass index
Prazo: Collected at week 1
Calculated from height, weight, age, sex
Collected at week 1
Parental feeding strategies
Prazo: Collected at week 1
Parent-reported questionnaire of feeding practices
Collected at week 1
Family demographics
Prazo: Collected at week 1
Parent-report questionnaire
Collected at week 1
Loss of control eating
Prazo: 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.
Collected at week 4
Inhibitory control and reward sensitivity questionnaires
Prazo: Collected on either week 1-3 (randomized)
Parent and child report of inhibitory control and reward sensitivity on a questionnaire
Collected on either week 1-3 (randomized)
Age
Prazo: Collected at the week 1
Age of participant
Collected at the week 1
Sex
Prazo: collected at week 1
sex of participant
collected at week 1
Parent height
Prazo: collected at week 1
height in cm of parent measured by a stadiometer
collected at week 1
Parent weight
Prazo: collected at week 1
weight in kg of parent measured by a standard digital scale
collected at week 1
parent body fat
Prazo: collected at week 1
measured by bioelectrical impedance
collected at week 1
Puberty Assessment Parental Report
Prazo: Collected at week 1
Parent report of pubertal status questionnaire
Collected at week 1

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Shana Adise, B.S., The Pennsylvania State University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de abril de 2015

Conclusão Primária (Real)

1 de outubro de 2016

Conclusão do estudo (Real)

1 de dezembro de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

29 de junho de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de agosto de 2016

Primeira postagem (Estimativa)

4 de agosto de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de janeiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de janeiro de 2021

Última verificação

1 de janeiro de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • DecisionMakingEatingKids01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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