- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
2021년 1월 7일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
관찰
등록 (실제)
142
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
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Pennsylvania
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University Park, Pennsylvania, 미국, 16802
- The Pennsylvania State University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
7년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Children aged 7-11 years old.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
기간: 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)
기간: 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
기간: Collected at either week 1-3 (randomized)
|
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
기간: Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
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Measured by performance on a go/nogo task with a reward incentive
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Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
|
Behavioral risk-taking and reward task
기간: 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
기간: Collected at either week 1-3 (randomized)
|
Measured by performance on a dietary self-control task
|
Collected at either week 1-3 (randomized)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Energy intake at baseline
기간: Collected at either week 1-3 (randomized)
|
Measured at an objective laboratory test-meal (kcal and grams)
|
Collected at either week 1-3 (randomized)
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Energy intake at a buffet meal
기간: 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
기간: Collected at either week 1-3 (randomized) following the baseline meal
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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).
기간: 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
기간: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
키
기간: 1주차에 수집
|
스타디오미터로 측정한 높이(cm)
|
1주차에 수집
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체지방률
기간: 1주차에 수집
|
생체 전기 임피던스 분석 척도로 평가
|
1주차에 수집
|
식욕 특성
기간: 1주차에 수집
|
어린이의 습관적 식습관에 대한 부모보고 설문지
|
1주차에 수집
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Liking of foods
기간: 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
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Fullness feelings
기간: 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
|
Collected at multiple time points during weeks 1-4
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Pubertal Development
기간: 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
기간: Collected at week 1
|
Weight in kg measured by a standard digital scale
|
Collected at week 1
|
Body mass index
기간: Collected at week 1
|
Calculated from height, age, sex
|
Collected at week 1
|
BMI percentile
기간: 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
기간: Collected at week 1
|
Calculated from height, weight, age and sex - according to CDC standards
|
Collected at week 1
|
Fat mass index
기간: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
Fat-free mass index
기간: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
Parental feeding strategies
기간: Collected at week 1
|
Parent-reported questionnaire of feeding practices
|
Collected at week 1
|
Family demographics
기간: Collected at week 1
|
Parent-report questionnaire
|
Collected at week 1
|
Loss of control eating
기간: 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
기간: 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
기간: Collected at the week 1
|
Age of participant
|
Collected at the week 1
|
Sex
기간: collected at week 1
|
sex of participant
|
collected at week 1
|
Parent height
기간: collected at week 1
|
height in cm of parent measured by a stadiometer
|
collected at week 1
|
Parent weight
기간: collected at week 1
|
weight in kg of parent measured by a standard digital scale
|
collected at week 1
|
parent body fat
기간: collected at week 1
|
measured by bioelectrical impedance
|
collected at week 1
|
Puberty Assessment Parental Report
기간: Collected at week 1
|
Parent report of pubertal status questionnaire
|
Collected at week 1
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Shana Adise, B.S., The Pennsylvania State University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 4월 1일
기본 완료 (실제)
2016년 10월 1일
연구 완료 (실제)
2017년 12월 1일
연구 등록 날짜
최초 제출
2016년 6월 29일
QC 기준을 충족하는 최초 제출
2016년 8월 3일
처음 게시됨 (추정)
2016년 8월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 7일
마지막으로 확인됨
2021년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .