- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03609255
Health Effects of Reducing Sedentary Behavior
23 oktober 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
21
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
-
Lubbock, Texas, Förenta staterna, 79409
- Texas Tech University - Department of Nutritional Sciences
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control group (C)
|
An educational handout for sedentary behavior and weekly neutral topic videos
|
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Experimentell: 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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Experimentell: Stress management group (SR)
|
Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Daily steps
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in low density lipoprotein (LDL) in SB
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 augusti 2018
Primärt slutförande (Faktisk)
8 oktober 2018
Avslutad studie (Faktisk)
8 oktober 2018
Studieregistreringsdatum
Först inskickad
16 juli 2018
Först inskickad som uppfyllde QC-kriterierna
24 juli 2018
Första postat (Faktisk)
1 augusti 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- TTUIRB2018-347
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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