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Effects of Interrupting Sedentary Behavior on Metabolic and Cognitive Outcomes in Children

Background:

- Some studies in adults have found that insulin and glucose blood levels are lower when a long period of sitting is broken up with walking, compared to sitting without breaks. This means that the body can better process sugars when there are walking breaks during the day. Researchers want to know if this is also true for children. Some studies have found that children s attention and memory might be better after exercise. Researchers want to know if short walking breaks have the same effects.

Objectives:

- To understand if breaking up sitting with walking helps children s bodies better use sugars and improves children s concentration.

Eligibility:

- Healthy children ages 7 to 11.

Design:

  • Participants will be screened with a physical exam, medical history, exercise test, picture vocabulary test, and medical tests including blood tests and X-rays.
  • Participants will return for two 7-hour visits. In the month before the visits, they will wear a physical activity monitor for one week so researchers know how active they are. Once they will take the sitting only test and once the sitting breaks test.
  • During the sitting only test, participants will sit for 3 hours.
  • During the sitting breaks test, they will sit for 3 hours with 3-minute walking breaks every 30 minutes.
  • Both days, they will drink sugar water. Then the participants will have blood drawn from a needle that is kept in place, and they will wear a heart monitor. They will take attention and working memory tests on a computer and answer questions about how they feel. They will eat a meal at the end of the test day.

研究概览

详细说明

Prevention of pediatric obesity and its complications are U.S. public health priorities. Promoting physical activity has been proposed as an intervention strategy. Apart from reducing excessive weight, physical activity improves cardiovascular fitness, insulin sensitivity, and academic performance. However, emerging evidence in adults suggests that increased physical activity may not entirely counteract the negative health effects of a sedentary lifestyle.

Sedentary behavior is defined as a set of low-intensity activities involving limited body movement (e.g.: TV viewing, prolonged sitting). TV viewing is associated with lower cognitive functioning and depressive symptoms. Some studies found higher levels of childhood sedentary behavior predicted higher body mass index (BMI) and cholesterol in adulthood, suggesting that negative health consequences may begin early. Dunstan et al. conducted the first lab-based study in adults investigating interrupting prolonged sedentary behavior with physical activity breaks. The authors found that for overweight adults, adding 2-minute moderate-intensity walking breaks every 20 minutes reduced postprandial insulin and glucose responses by 23.0% and 29.6%, respectively. Thus, interrupting sedentary behavior may be an intervention strategy to reduce health risks.

In children, cross-sectional observational studies indicate that sedentary behavior patterns characterized by short bouts of activity are not associated with increased cardiometabolic risk. However to date, no in-lab studies have manipulated sedentary behavior in children. Therefore, we propose to conduct a randomized crossover pilot feasibility study to assess whether interrupting sedentary behavior influences metabolic and executive function, attention, mood, anxiety, and dietary intake. Children, ages 7-11 years, will complete two conditions in random order: 3 hours of prolonged sitting and 3 hours of sitting interrupted with 3 minutes of moderate-intensity walking every 30 minutes. The specific aim of this project is to investigate whether interrupting sedentary behavior improves metabolic parameters and changes executive function, attention, mood, anxiety, and dietary intake. The primary hypothesis is that postprandial insulin incremental area under the curve (iAUC) will be lower in the interrupted sitting vs. the prolonged sitting condition. The exploratory secondary hypotheses are that glucose iAUC, executive function, attention, mood, anxiety, and dietary intake will differ between the two conditions.

This project will investigate if interrupting sedentary time affects potential negative health consequences of sedentary behavior in children. If interrupting sedentary time in short bouts has beneficial effects among children, interventions examining the frequency, duration, and intensity of such interruptions could be developed. Thus, these results have the potential to provide insight into novel behavioral intervention targets in youth.

研究类型

介入性

注册 (实际的)

89

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

7年 至 11年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

Participants will qualify for the study if they meet the following criteria:

  1. Good general health.
  2. Age greater than or equal to 7 and <11.99 years.
  3. Fasting plasma glucose < 100 mg/dL
  4. a) Phase 1: Body mass index (BMI) between the 5th and 85th percentiles, as determined by the CDC age- and sex- specific growth charts.

    b) Phase 2: BMI above the 85th percentile, as determined by the CDC age- and sex- specific growth charts.

EXCLUSION CRITERIA:

  1. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion.
  2. Evidence of impaired glucose tolerance or type 2 diabetes, including fasting plasma glucose greater than or equal to 100 mg/dL.
  3. Presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome).
  4. Participants who have, or whose parent/guardians have, current substance abuse or a psychiatric disorder or other condition that, in the opinion of the investigators, would impede competence, compliance, or prevent the completion of the study.
  5. Participants who have, or are currently receiving, anti-psychotic drugs that would affect metabolism, cognitive outcomes, and body habitus.
  6. Participants receiving medical treatment other than diet for hypertension or dyslipidemia.
  7. Participants with precocious puberty and/or receiving androgen and estrogen therapy.
  8. Participants currently taking medications for ADHD, or any disorder or use of medications known to affect body composition or weight.
  9. Presence of pre-existing neurocognitive disabilities, or an age-adjusted score below 85 on the Picture Vocabulary Test at the screening visit.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Lower insulin incremental area under the curve (iAUC) during 3 hours after the OGTT.
大体时间:3 hours
3 hours

次要结果测量

结果测量
大体时间
Lower postprandial glucose iAUC during 3 hours after the OGTT.
大体时间:3 hours
3 hours
Differences in executive functioning and attention scores.
大体时间:3 hours
3 hours
Differences in positive and negative affect scores.
大体时间:3 hours
3 hours
Differences in anxiety.
大体时间:3 hours
3 hours
Differences in post-test dietary intake.
大体时间:3 hours
3 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年6月26日

初级完成 (实际的)

2017年3月8日

研究完成 (实际的)

2018年1月29日

研究注册日期

首次提交

2013年6月26日

首先提交符合 QC 标准的

2013年6月26日

首次发布 (估计)

2013年6月28日

研究记录更新

最后更新发布 (实际的)

2018年1月31日

上次提交的符合 QC 标准的更新

2018年1月30日

最后验证

2018年1月29日

更多信息

与本研究相关的术语

其他研究编号

  • 130169
  • 13-CH-0169

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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