- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03609255
Health Effects of Reducing Sedentary Behavior
23 ottobre 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
21
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Texas
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Lubbock, Texas, Stati Uniti, 79409
- Texas Tech University - Department of Nutritional Sciences
-
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Control group (C)
|
An educational handout for sedentary behavior and weekly neutral topic videos
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Sperimentale: 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
|
Sperimentale: Stress management group (SR)
|
Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Daily steps
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes in low density lipoprotein (LDL) in SB
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 agosto 2018
Completamento primario (Effettivo)
8 ottobre 2018
Completamento dello studio (Effettivo)
8 ottobre 2018
Date di iscrizione allo studio
Primo inviato
16 luglio 2018
Primo inviato che soddisfa i criteri di controllo qualità
24 luglio 2018
Primo Inserito (Effettivo)
1 agosto 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 ottobre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 ottobre 2018
Ultimo verificato
1 ottobre 2018
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- TTUIRB2018-347
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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