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临床试验/NCT03254576
NCT03254576已完成不适用

Cue-Reward Learning and Weight Gain in Youth

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
147
试验地点
1
主要终点
Weight gain

研究概览

简要总结

The objective of the study is to compare children at low risk for obesity (two healthy weight parents) to children at high risk for obesity (two overweight parents) in their response rate to food taste and in their rate of learning using fMRI.

详细描述

The primary aim of this project is to conduct an adequately powered study that compares children at low risk for obesity to children at high risk for obesity on their brain responses to food tastes during a pavlovian learning task. Seven assessment visits will be conducted at three separate time points; baseline, 1-year follow up, and 2-year follow up. Assessments will include anthropometry, interviews, computer tasks, questionnaires, and an fMRI scan. This program of research tests a novel hypothesis regarding overeating and the development of obesity in children, and could provide critical data on individual vulnerabilities to overeating for further research. Furthermore, this study could provide mechanisms for intervention with regards to cue-reward learning in children, to ultimately prevent obesity in youth.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy weight children between the ages of 8 and 11 Years
  • BMI 5-75th percentile
  • Child must be right-handed
  • Child must be willing to participate in an fMRI scan
  • Either two biological parents who are overweight/obese or no biological parents that are overweight/obese
  • One biological parent willing to bring child to assessment visits
  • Child and participating parent Fluent in English for speaking, reading, and writing
  • Child must like cheese pizza and chocolate milkshake

排除标准

  • Child overweight (BMI≥85th percentile)
  • Child diagnoses of a serious chronic physical disease (e.g., diabetes) for which physician supervision of diet and exercise prescription are needed
  • Child who is taking medications that may impact brain responses (can take kids who are stable on meds)
  • Child with MRI contraindications (presence of metallic foreign object or device in body, piercings that cannot be removed, tattooed permanent makeup that contain metal, braces, head trauma, claustrophobia, use of Bigen permanent hair dye)
  • Child with an active eating disorder (reported on EDE interview) or with first degree relative with Anorexia Nervosa or Bulimia Nervosa
  • Cognitive impairment or disability determined through parent and child self-report measures, and parent reported child individual education plan
  • Vision problems uncorrectable with lenses
  • Food allergies related to cheese pizza, chocolate milkshake, or the snack foods used in the study
  • Menarche in female participants at time of enrollment
  • Children scoring within the midpubertal range or higher based on the Pubertal Development Scale

结局指标

主要结局

Weight gain

时间窗: Change from baseline at an average of 12 months and 24 months

Whether rate of cue reward and reward sensitivity predict weight gain

Cue-reward learning

时间窗: Baseline only

Whether rate of the shift in BOLD response from food cue to neutral cue is different between high and low-risk children

Reward Sensitivity

时间窗: Baseline only

Whether the BOLD response to food cue differs between high and low-risk children

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

Kerri Boutelle

Professor

University of California, San Diego

研究点 (1)

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