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Health Effects of Reducing Sedentary Behavior

23. Oktober 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

21

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Texas
      • Lubbock, Texas, Vereinigte Staaten, 79409
        • Texas Tech University - Department of Nutritional Sciences

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Control group (C)
Verhalten: Control
An educational handout for sedentary behavior and weekly neutral topic videos
Experimental: Sedentary behavior group (SB)
Verhalten: Reducing sedentary behavior
Educational handouts for sedentary behavior and strategies reducing sedentary behavior and weekly videos related to reduced sedentary behavior
Experimental: Stress management group (SR)
Verhalten: Reducing stress
Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Daily steps
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in daily steps measured via pedometer.
Baseline (pre-intervention) and 4 weeks (post-intervention)
Stress improvement in sedentary behavior group (SB)
Zeitfenster: 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)
Stress improvement in sedentary behavior group (SB)
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
Improvement in stress as measured via salivary cortisol in SB.
Baseline (pre-intervention) and 4 weeks (post-intervention)
Stress improvement in stress management group (SR)
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
Improvement in stress as measured via Perceived Stress Scale (PSS) in SR.
Baseline (pre-intervention) and 4 weeks (post-intervention)
Stress improvement in stress management group (SR)
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
Improvement in stress as measured via salivary cortisol in SR.
Baseline (pre-intervention) and 4 weeks (post-intervention)
Compare the changes of stress levels between SB and SR
Zeitfenster: 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)
Compare the changes of stress levels between SB and SR
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
Compare the changes of stress levels as measured via salivary cortisol between SB and SR.
Baseline (pre-intervention) and 4 weeks (post-intervention)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in low density lipoprotein (LDL) in SB
Zeitfenster: 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
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
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
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in TC as measured via finger stick in SB.
Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in triglyceride (TG) in SB
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
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
Zeitfenster: 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
Zeitfenster: 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)
Changes in weight in SB
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in weight as measured via BODPOD in SB.
Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in blood pressure in SB
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in blood pressure as measured via Omron Digital BP Monitor HEM-907XL in SB.
Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in low density lipoprotein (LDL) in SR
Zeitfenster: 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)
Changes in high density lipoprotein (HDL) in SR
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Compared the changes in HDL between SB and SR
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Compared the changes in body fat between SB and SR
Zeitfenster: Baseline (pre-intervention) and 4 weeks (post-intervention)
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
Zeitfenster: 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
Zeitfenster: 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)
Change in resting energy expenditure in SB
Zeitfenster: 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)
Change in resting energy expenditure in SR
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Texas Tech University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. August 2018

Primärer Abschluss (Tatsächlich)

8. Oktober 2018

Studienabschluss (Tatsächlich)

8. Oktober 2018

Studienanmeldedaten

Zuerst eingereicht

16. Juli 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juli 2018

Zuerst gepostet (Tatsächlich)

1. August 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Oktober 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Oktober 2018

Zuletzt verifiziert

1. Oktober 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • TTUIRB2018-347

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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