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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03609255
Other study ID # TTUIRB2018-347
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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