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临床试验/NCT02451436
NCT02451436已完成不适用

Pilot Study of a Sleep and Media Intervention to Improve Adolescents' Metabolic Health and Weight Status

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2015年3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
87
试验地点
2
主要终点
Body composition

研究概览

简要总结

This study aims to assess the effects of a sleep and media intervention on adolescents' overall health.

详细描述

Introduction. Over the last 30 years, the obesity rate in adolescents has more than tripled, and more than one-third of adolescents were obese in 2010. Many of the complications associated with obesity, including glucose intolerance, hypertension, dyslipidemia and markers of inflammation such as interleukin-6 (IL-6) and C-reactive protein (CRP), are already present in adolescence. The incidence of type 2 diabetes in adolescents has also increased, especially in minorities. Current lifestyle interventions for obesity and type 2 diabetes focused on altering energy balance have not shown promising long-term outcomes. Further research is needed to better understand factors that alter metabolism in order to create more effective interventions.

As obesity and type 2 diabetes rates have risen, adolescents' sleep duration has decreased. Despite requiring more sleep than other children, adolescents often do not obtain adequate sleep. There are many reasons for this decrease in sleep, including delayed circadian rhythm, increased academic demands and extracurricular activities, minimal parental supervision and increased media use. Media use among adolescents has increased significantly over the last 5 years and has been shown to affect adolescents' sleep. It has also been found to be an etiological factor in adolescent obesity.

Experimental studies with adolescents and adults suggest that inadequate sleep duration and poor sleep quality are associated with insulin resistance, glucose intolerance, increased ghrelin and increased markers of inflammation. However, no previous study has successfully examined the effects of a longer-term sleep intervention on factors related to obesity and type 2 diabetes. We propose that short sleep and poor sleep quality may lead to obesity and type 2 diabetes through 2 mechanisms: 1) increased ghrelin, which can lead to increased food intake, decreased energy expenditure and impaired glycemic control, and 2) decreased insulin sensitivity, which also increases insulin. These changes in energy balance and metabolism could lead to weight gain over time and increase adolescents' risk for type 2 diabetes.

Methods. This study aims to assess the effects of a sleep and media use intervention on adolescent body composition, ghrelin and insulin sensitivity. In a randomized controlled trial, 15-17 year olds who are obese and who do not obtain adequate sleep will be randomized to one of two groups: a sleep intervention group or a study skills control group. The sleep intervention group will receive four sessions including cognitive behavioral training aimed at increasing sleep duration, education on the effects of media use on sleep and problem solving with the participant and parent about increasing sleep duration and decreasing nighttime media use. The control group will receive four sessions of study skills training. Sleep duration will be measured by actigraphy, television use will be measured by the TV Allowance device (Family Safe Media, Salt Lake City, UT), and cell phone use will be measured by cellular provider reports and the Break Free mobile application (Mobifolio). Blood draws will be performed 7 days before and after the intervention and at the 3-month follow-up. Body composition will be assessed by dual-energy X-ray absorptiometry (DXA).

Hypotheses and Specific Aims. Primary Aim. Conduct a two-arm parallel group randomized controlled trial of the relative effects of an intervention for adolescent sleep duration and media use on adolescents' sleep duration and quality, insulin sensitivity, appetite-regulating hormones and body composition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Males or females ages 15-17
  • BMI ≥85th percentile
  • Android cell phone
  • Average normal sleep duration ≤ 7.5 hours

排除标准

  • Sleep disorders
  • Severe intellectual disability
  • Severe mental illness
  • For the COVID-19 assessment, participants enrolled prior to COVID-19 were eligible for the COVID-19 follow-up visit.

结局指标

主要结局

Body composition

时间窗: Change from baseline body composition to 3 months after intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19

Assessed through DXA

Ghrelin

时间窗: Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19

Assessed through blood draw

Insulin

时间窗: Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19

Assessed through blood draw

Sleep Duration

时间窗: Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19

Assessed via Actigraphy

次要结局

  • Cell Phone Application Use(Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19)
  • hs-CRP(Change from baseline to 1 week after the intervention and 3 months after the intervention and during COVID-19 pandemic if they were enrolled prior to COVID-19)

研究者

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

Aaron Fobian

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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