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临床试验/NCT03766191
NCT03766191已完成不适用

The Relation of Genetic Factors, Food Cues, and Self-Regulation With Excess Consumption and Adiposity in Children

Trustees of Dartmouth College1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2019年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
1
主要终点
Change in BMI

研究概览

简要总结

This study assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (EAH), and adiposity gain in children.

详细描述

The investigators will assess the associations between genetic factors, food-cue-related neural reactivity, eating in the absence of hunger (EAH) in response to food cues, and adiposity gain in children. They will also determine whether self-regulatory capacity modifies these associations. The genetic factors explored specifically include FTO, MC4R, polymorphisms in genes involved in dopaminergic pathways, and a composite genetic risk score built from genome-wide obesity-related loci.

[3/14/2020]: Study recruitment temporarily halted due to the COVID-19 pandemic

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •English fluency
  • •Willingness to participate in all study visits

排除标准

  • •Relevant food allergies or dietary restrictions
  • •Metal in or on the body
  • •Claustrophobia
  • •Psychiatric and neurological disorders
  • •Relative in the study
  • •Appetite- or attention-altering medications or disorders

研究组 & 干预措施

Food Ads and fMRI

Active Comparator

Exposure to food ads during an fMRI scan

干预措施: Food Ads (Behavioral)

Non-Food Ads and fMRI

Sham Comparator

Exposure to non-food ads during an fMRI scan

干预措施: Non-food Ads (Other)

Food Ads and TV show

Active Comparator

Exposure to food ads embedded in an age-appropriate TV program

干预措施: Food Ads (Behavioral)

Non-Food Ads and TV show

Sham Comparator

Exposure to non-food ads embedded in an age-appropriate TV program

干预措施: Non-food Ads (Other)

结局指标

主要结局

Change in BMI

时间窗: Baseline, 1-year followup

Difference between BMI z-score according to the Center for DiseaSe Control 2000 Growth Reference Curves assessed at baseline and follow-up. Investigators will assess the associations between genetic factors (polymorphisms in FTO, MC4R; and a genetic obesity risk score), food-cue-related neural activity and EAH with change in BMI.

Food-cue-related neural activity

时间窗: Baseline

Activation in brain reward regions in response to food vs. non-food cues, as measured by differences in the blood-oxygen-level dependent response during fMRI scans. Investigators will examine associations between polymorphisms in FTO, MC4R, as well as a genetic risk score with the differential neural activity.

Food-cue-related Eating in the Absence of Hunger (EAH)

时间窗: Baseline, 2 weeks, 4 weeks

Difference in kcals consumed in response to food vs. non-food cue exposure in the behavioral sessions. Investigators will examine how differential neural activity in response to food vs. non-food cues will relate to EAH. Investigators will also assess whether self-regulatory capacity diminishes this association between differential neural activity and EAH.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diane Gilbert-Diamond

Associate Professor

Trustees of Dartmouth College

研究点 (1)

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