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.
調査の概要
研究の種類
介入
入学 (実際)
21
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Texas
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Lubbock、Texas、アメリカ、79409
- Texas Tech University - Department of Nutritional Sciences
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Control group (C)
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An educational handout for sedentary behavior and weekly neutral topic videos
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Daily steps
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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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)
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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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)
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Improvement in stress as measured via salivary cortisol in SB.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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Stress improvement in stress management group (SR)
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Improvement in stress as measured via Perceived Stress Scale (PSS) in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
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Stress improvement in stress management group (SR)
時間枠：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
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Compare the changes of stress levels as measured via Perceived Stress Scale (PSS) between SB and 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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in low density lipoprotein (LDL) in SB
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in LDL as measured via finger stick in SB.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in high density lipoprotein (HDL) in SB
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in HDL as measured via finger stick in SB.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in total cholesterol (TC) in SB
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in TC as measured via finger stick in SB.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in triglyceride (TG) in SB
時間枠：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)
|
|
Changes in fasting blood glucose in SB
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in fasting blood glucose as measured via finger stick in SB.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in body fat in SB
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in body fat as measured via BODPOD in SB.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in weight in SB
時間枠：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
時間枠：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
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in LDL as measured via finger stick in SR.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Changes in high density lipoprotein (HDL) in SR
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in HDL as measured via finger stick in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
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Changes in total cholesterol (TC) in SR
時間枠：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)
|
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Changes in triglyceride (TG) in SR
時間枠：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)
|
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Changes in fasting blood glucose in SR
時間枠：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)
|
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Changes in body fat in SR
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Changes in body fat as measured via BODPOD in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
|
Changes in weight in SR
時間枠：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
時間枠：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)
|
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Compared the changes in LDL between SB and SR
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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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
時間枠：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
時間枠：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
時間枠：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)
|
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Compared the changes in fasting blood glucose between SB and SR
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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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
時間枠：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)
|
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Compared the changes in weight between SB and SR
時間枠：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
時間枠：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
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Change in resting energy expenditure as measured by metabolic cart in SB.
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Baseline (pre-intervention) and 4 weeks (post-intervention)
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Change in resting energy expenditure in SR
時間枠：Baseline (pre-intervention) and 4 weeks (post-intervention)
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Change in resting energy expenditure as measured by metabolic cart in SR.
|
Baseline (pre-intervention) and 4 weeks (post-intervention)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年8月13日
一次修了 (実際)
2018年10月8日
研究の完了 (実際)
2018年10月8日
試験登録日
最初に提出
2018年7月16日
QC基準を満たした最初の提出物
2018年7月24日
最初の投稿 (実際)
2018年8月1日
学習記録の更新
投稿された最後の更新 (実際)
2018年10月24日
QC基準を満たした最後の更新が送信されました
2018年10月23日
最終確認日
2018年10月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- TTUIRB2018-347
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Controlの臨床試験
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University of Southern MississippiMilitary Suicide Research Consortium招待による登録
-
Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)募集
-
University of British ColumbiaUniversity of Victoria; Social Sciences and Humanities Research Council of Canada完了
-
Johns Hopkins UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD); GN Otometrics完了
-
Devicare S.L.Clever Instruments S.L.; Fundacio Puigvertわからない
-
W.L.Gore & Associates完了胸部疾患スウェーデン, オランダ, スペイン, ドイツ, フランス, イギリス, イタリア
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Massachusetts General HospitalHarvard University; American Academy of Child Adolescent Psychiatry.わからない
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Singapore General HospitalDuke-NUS Graduate Medical Schoolわからない