Health Effects of Reducing Sedentary Behavior
2018年10月23日 更新者：Martin Binks、Texas Tech University
A recent review indicated that sedentary behavior has been associated with increased morbidity and mortality but the intervention studies frequently focus only on changing sedentary behavior (reducing sedentary time) without measuring health-associated outcomes.
Elevated cortisol (related to stress) has been linked with health risks.
Improved physical fitness has been linked with improved cortisol responses to psychosocial stressors.
In addition, increased physical activity induced favorable effects upon low density lipoprotein, high density lipoprotein, and total cholesterol.
Previous study also indicated that increasing daily steps have positive effect on blood glucose in people with impaired glucose tolerance.
Ultimately, the investigators think that sedentary intervention and stress management may have benefits on these health indicators.
As such the investigators will examine whether sedentary intervention or stress management can have positive effect on human health by measuring salivary cortisol, blood lipid profile, fasting blood glucose, blood pressure, resting energy expenditure, and body composition.
研究概览
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
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
-
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Texas
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Lubbock、Texas、美国、79409
- Texas Tech University - Department of Nutritional Sciences
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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
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age: 18-65 years.
Exclusion Criteria:
- Unable/unwilling to provide informed consent.
- Having mobility impairment.
- Current severe untreated depression (i.e., score in the severe depression range on the Hospital Anxiety and Depression Scale; HADS).
- Women who are pregnant or nursing.
- Currently smoking (within last 12 months).
- Currently use medications that affect salivary cortisol level (i.e. prednisone, dexamethasone).
- Have been diagnosed Addison's disease.
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：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Control group (C)
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An educational handout for sedentary behavior and weekly neutral topic videos
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实验性的：Sedentary behavior group (SB)
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Educational handouts for sedentary behavior and strategies reducing sedentary behavior and weekly videos related to reduced sedentary behavior
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实验性的：Stress management group (SR)
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Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Daily steps
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in daily steps measured via pedometer.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Stress improvement in sedentary behavior group (SB)
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Improvement in stress as measured via Perceived Stress Scale (PSS) in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Stress improvement in sedentary behavior group (SB)
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Improvement in stress as measured via salivary cortisol in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Stress improvement in stress management group (SR)
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Improvement in stress as measured via Perceived Stress Scale (PSS) in SR.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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Stress improvement in stress management group (SR)
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Improvement in stress as measured via salivary cortisol in SR.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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Compare the changes of stress levels between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Compare the changes of stress levels as measured via Perceived Stress Scale (PSS) between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Compare the changes of stress levels between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Compare the changes of stress levels as measured via salivary cortisol between SB and SR.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in low density lipoprotein (LDL) in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in LDL as measured via finger stick in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in high density lipoprotein (HDL) in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in HDL as measured via finger stick in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in total cholesterol (TC) in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in TC as measured via finger stick in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Changes in triglyceride (TG) in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in TG as measured via finger stick in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Changes in fasting blood glucose in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in fasting blood glucose as measured via finger stick in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in body fat in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in body fat as measured via BODPOD in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in weight in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in weight as measured via BODPOD in SB.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Changes in blood pressure in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in blood pressure as measured via Omron Digital BP Monitor HEM-907XL in SB.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Changes in low density lipoprotein (LDL) in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in LDL as measured via finger stick in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Changes in high density lipoprotein (HDL) in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in HDL as measured via finger stick in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in total cholesterol (TC) in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in TC as measured via finger stick in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in triglyceride (TG) in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in TG as measured via finger stick in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in fasting blood glucose in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in fasting blood glucose as measured via finger stick in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in body fat in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in body fat as measured via BODPOD in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in weight in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in weight as measured via BODPOD in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in blood pressure in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Changes in blood pressure as measured via Omron Digital BP Monitor HEM-907XL in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Compared the changes in LDL between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Compared the changes in LDL between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Compared the changes in HDL between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Compared the changes in HDL between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Compared the changes in TC between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Compared the changes in TC between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Compared the changes in TG between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Compared the changes in TG between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Compared the changes in fasting blood glucose between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Compared the changes in fasting blood glucose between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Compared the changes in body fat between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Compared the changes in body fat between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Compared the changes in weight between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Compared the changes in weight between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Compared the changes in blood pressure between SB and SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Compared the changes in blood pressure between SB and SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Change in resting energy expenditure in SB
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Change in resting energy expenditure as measured by metabolic cart in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
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Change in resting energy expenditure in SR
大体时间：Baseline (pre-intervention) and 4 weeks (post-intervention)
|
Change in resting energy expenditure as measured by metabolic cart in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
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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。
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 (实际的)
2018年8月13日
初级完成 (实际的)
2018年10月8日
研究完成 (实际的)
2018年10月8日
研究注册日期
首次提交
2018年7月16日
首先提交符合 QC 标准的
2018年7月24日
首次发布 (实际的)
2018年8月1日
研究记录更新
最后更新发布 (实际的)
2018年10月24日
上次提交的符合 QC 标准的更新
2018年10月23日
最后验证
2018年10月1日
更多信息
与本研究相关的术语
其他研究编号
- TTUIRB2018-347
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
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.
Control的临床试验
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Devicare S.L.Clever Instruments S.L.; Fundacio Puigvert未知
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Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)招聘中
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Gonzalez-Heydrich, Joseph, M.D.Boston Children's Hospital; Harvard University完全的
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University of Puerto RicoNational Institutes of Health (NIH)招聘中
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Ananda Basu, MDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); DexCom, Inc.; Tandem...完全的
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United States Department of DefenseVirginia Commonwealth University; James J. Peters Veterans Affairs Medical Center; Hunter Holmes...完全的