Health Effects of Reducing Sedentary Behavior

General Population Clinical Trial

Official title:

Health Effects of Reducing Sedentary Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609255
• Other study ID #: TTUIRB2018-347
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: October 8, 2018

Study information

• Verified date: October 2018
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 8, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• General Population

Intervention

Behavioral:
• Reducing sedentary behavior
Educational handouts for sedentary behavior and strategies reducing sedentary behavior and weekly videos related to reduced sedentary behavior
• Reducing stress
Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management
• Control
An educational handout for sedentary behavior and weekly neutral topic videos

Locations

Country	Name	City	State
United States	Texas Tech University - Department of Nutritional Sciences	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily steps	Changes in daily steps measured via pedometer.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Primary	Stress improvement in sedentary behavior group (SB)	Improvement in stress as measured via Perceived Stress Scale (PSS) in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Primary	Stress improvement in sedentary behavior group (SB)	Improvement in stress as measured via salivary cortisol in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Primary	Stress improvement in stress management group (SR)	Improvement in stress as measured via Perceived Stress Scale (PSS) in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Primary	Stress improvement in stress management group (SR)	Improvement in stress as measured via salivary cortisol in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Primary	Compare the changes of stress levels between SB and SR	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)
Primary	Compare the changes of stress levels between SB and SR	Compare the changes of stress levels as measured via salivary cortisol between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in low density lipoprotein (LDL) in SB	Changes in LDL as measured via finger stick in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in high density lipoprotein (HDL) in SB	Changes in HDL as measured via finger stick in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in total cholesterol (TC) in SB	Changes in TC as measured via finger stick in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in triglyceride (TG) in SB	Changes in TG as measured via finger stick in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in fasting blood glucose in SB	Changes in fasting blood glucose as measured via finger stick in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in body fat in SB	Changes in body fat as measured via BODPOD in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in weight in SB	Changes in weight as measured via BODPOD in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in blood pressure in SB	Changes in blood pressure as measured via Omron Digital BP Monitor HEM-907XL in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in low density lipoprotein (LDL) in SR	Changes in LDL as measured via finger stick in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in high density lipoprotein (HDL) in SR	Changes in HDL as measured via finger stick in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in total cholesterol (TC) in SR	Changes in TC as measured via finger stick in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in triglyceride (TG) in SR	Changes in TG as measured via finger stick in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in fasting blood glucose in SR	Changes in fasting blood glucose as measured via finger stick in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in body fat in SR	Changes in body fat as measured via BODPOD in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in weight in SR	Changes in weight as measured via BODPOD in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Changes in blood pressure in SR	Changes in blood pressure as measured via Omron Digital BP Monitor HEM-907XL in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Compared the changes in LDL between SB and SR	Compared the changes in LDL between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Compared the changes in HDL between SB and SR	Compared the changes in HDL between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Compared the changes in TC between SB and SR	Compared the changes in TC between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Compared the changes in TG between SB and SR	Compared the changes in TG between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Compared the changes in fasting blood glucose between SB and SR	Compared the changes in fasting blood glucose between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Compared the changes in body fat between SB and SR	Compared the changes in body fat between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Compared the changes in weight between SB and SR	Compared the changes in weight between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Compared the changes in blood pressure between SB and SR	Compared the changes in blood pressure between SB and SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Change in resting energy expenditure in SB	Change in resting energy expenditure as measured by metabolic cart in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary	Change in resting energy expenditure in SR	Change in resting energy expenditure as measured by metabolic cart in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)