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临床试验/NCT05853393
NCT05853393已完成不适用

Sleep and Eating Behaviors in Rural Preadolescent Children (Tween SPACE [Sleep Patterns, Appetite Control, and Environment])

Penn State University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2023年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
Occurrence of eating in the absence of hunger (EAH) episodes

研究概览

简要总结

The goal of this study is to learn about how children's sleep is related to their eating behaviors the next day, and to learn about factors that relate to eating behaviors and sleep health that are specific to preadolescent children living in rural communities.

详细描述

The aims of this study are to a) describe the prevalence and characteristics of eating in the absence of hunger (EAH) in rural preadolescent children using a novel methodology, ecological momentary assessment (EMA); b) to examine the within-person temporal relationship between daily changes in sleep health (i.e., duration and quality) and EAH; and c) examine associations between family, child, and environmental characteristics, sleep, and eating behaviors in rural preadolescent children. Parent-child dyads will participate in the study via remote data collection methods including Zoom interviews, online surveys, EMA survey completed by smartphone, and actigraphy.

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 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 8 to 12 years
  • Primary residence is in a rural ZIP code in the United States, as defined by Health Resources & Services Administration
  • BMI for age ≥ 85th percentile OR BMI ≥ 15th percentile plus at least one biological parent with BMI ≥ 25 kg/m2
  • Able to read and answer questions in English
  • Parent Inclusion criteria:
  • Parent or caregiver of an eligible child
  • Age 18 years or older
  • Able to read and answer questions in English

排除标准

  • Any medical condition that significantly impacts eating, sleep, growth, or ability to operate the mEMA smartphone platform (e.g., eating disorder, Type I diabetes, blindness) (Child participants only)
  • Unable to connect to a Zoom session via internet or cell-phone data from home
  • Unable to receive and sign for package with study supplies

结局指标

主要结局

Occurrence of eating in the absence of hunger (EAH) episodes

时间窗: Multiple measurements per day for 2 weeks starting at enrollment through 2 weeks

Eating events where pre-meal hunger is less than 35 on a 100 point visual analogue scale, as reported on smartphone surveys that are completed multiple times a day over a 2 week period.

次要结局

  • Body mass index z-score(At enrollment)
  • Visual analogue scale rating of hunger(Multiple measurements per day for 2 weeks)
  • Visual analogue scale rating of fullness(Multiple measurements per day for 2 weeks)
  • Visual analogue scale rating of desire to eat(Multiple measurements per day for 2 weeks)
  • Child appetitive traits(At enrollment)
  • Child mindful eating(At enrollment)
  • Child eating motivations(At enrollment)
  • Child restrained and disinhibited eating(At enrollment)
  • Sleep duration(Daily over 2 weeks)
  • Sleep maintenance efficiency(Daily over 2 weeks)

研究者

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

Emily Hohman

Assistant Research Professor

Penn State University

研究点 (1)

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