Health Effects of Reducing Sedentary Behavior
23 octobre 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
21
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Texas
-
Lubbock, Texas, États-Unis, 79409
- Texas Tech University - Department of Nutritional Sciences
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Control group (C)
|
An educational handout for sedentary behavior and weekly neutral topic videos
|
|
Expérimental: Sedentary behavior group (SB)
|
Educational handouts for sedentary behavior and strategies reducing sedentary behavior and weekly videos related to reduced sedentary behavior
|
|
Expérimental: Stress management group (SR)
|
Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Daily steps
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in low density lipoprotein (LDL) in SB
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 août 2018
Achèvement primaire (Réel)
8 octobre 2018
Achèvement de l'étude (Réel)
8 octobre 2018
Dates d'inscription aux études
Première soumission
16 juillet 2018
Première soumission répondant aux critères de contrôle qualité
24 juillet 2018
Première publication (Réel)
1 août 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 octobre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 octobre 2018
Dernière vérification
1 octobre 2018
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- TTUIRB2018-347
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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