- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02855398
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.
Publicações Gerais
- 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.
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DecisionMakingEatingKids01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .