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临床试验/NCT07095166
NCT07095166招募中不适用

Monitoring Eating Across Locations (MEAL) - Timing, Intake, and Mealtime Evaluation (TIME)

Penn State University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Child body mass index

研究概览

简要总结

Increased availability of high-energy dense foods has contributed to a pediatric obesity epidemic, with 23% of United States children currently presenting with the disease. How children eat contributes to both overconsumption and greater adiposity. However, it is unclear if laboratory measures of children's eating style generalize to the home environment, where children consume two thirds of their total energy. The study will 1) test if child eating styles observed in the lab generalize to more ecologically valid home environments and 2) identify aspects of home food environment that amplify obesogenic eating behaviors. We will assess laboratory and home eating styles (e.g., bite rate) in 100 prepubertal 6-9-year-old children to constrain variability in energy requirements. Children will be video-recorded while consuming identical study-provided meals at home and in the laboratory (counter-balanced order) in addition to a 'typical' meal at home. To study how adiposity relates to "obesogenic" styles of eating, gold standard dual x-ray absorptiometry will be used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None (Participant)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children must be between the ages of 6-9 years-old
  • children are of good health with no learning disabilities (e.g., ADHD, determined by parent report)
  • children are not on any medications known to impact body weight, taste, food intake, behavior, or blood flow
  • parents report that children like and are willing to eat study foods

排除标准

  • Children are not within the age requirements (<6 years old or > 9 years old)
  • If children are taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow.
  • If children don't speak English.
  • If children are colorblind.
  • If children have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
  • If children have a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing's syndrome, Down's syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy.
  • If children are allergic to foods or ingredients used in the study.
  • child received an X-ray in the previous year (to avoid excess radiation exposure due to the DXA scans performed in the research)

研究组 & 干预措施

Home vs Lab Eating Behavior

Experimental

Examine differences in participants' eating at home versus in the lab

干预措施: Meal Location (Behavioral)

结局指标

主要结局

Child body mass index

时间窗: Day 1

child height and weight will be measured

Food intake in grams during a standard meal

时间窗: Day 1 and Day 2 or 3 depending on randomization

Intake in grams from standard meal

Food intake in grams during a snack buffet when not hungry

时间窗: Day 1

Intake in grams during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Food intake in kcal during a standard meal

时间窗: Day 1 and Day 2 or 3 depending on randomization

Intake in kcal during a standard meal

Food intake in kcal during a snack buffet when not hungry

时间窗: Day 1

Intake in kcal during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Food intake in grams during a Study Meal

时间窗: Day 2 or 3 depending on randomization and home meal administration

Intake in grams from Study Meal

Food intake in kcal during the Study Meal

时间窗: Day 2 or 3 depending on randomization and home meal administration

Intake in kcal during the Study Meal

Body Composition

时间窗: Day 1

Dual-energy X-ray absorptiometry to assess body composition including fat mass and fat-free mass in children

Video coding of the study meal

时间窗: Day 2 or 3 depending on randomization and home meal administration

A digital recording of the child eating a Study Meal will be saved. The study team have developed a behavior coding protocol to measure child meal microstructure (e.g., bites, bite size, meal duration) and have also validated a computational model to assess cumulative intake curves from video coded bite data.

Video coding of home meals

时间窗: Week 1 and Week 2

Digital recordings of the child eating a typical meals at home. The study team have developed a behavior coding protocol to measure child meal microstructure (e.g., bites, bite size, meal duration) and have also validated a computational model to assess cumulative intake curves from video coded bite data.

Video coding of standard meal

时间窗: Day 1 and Day 2 or 3 depending on randomization

A digital recording of the child eating a standard meal will be saved. The study team have developed a behavior coding protocol to measure child meal microstructure (e.g., bites, bite size, meal duration) and have also validated a computational model to assess cumulative intake curves from video coded bite data.

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

Alaina Pearce

PI

Penn State University

研究点 (1)

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