Clinical trial NCT03609255: Health Effects of Reducing Sedentary Behavior
Official title: Health Effects of Reducing Sedentary Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Population
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Daily steps
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Stress improvement in sedentary behavior group (SB)
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Stress improvement in sedentary behavior group (SB)
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Stress improvement in stress management group (SR)
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Stress improvement in stress management group (SR)
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compare the changes of stress levels between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compare the changes of stress levels between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
Secondary outcomes:
measure: Changes in low density lipoprotein (LDL) in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in high density lipoprotein (HDL) in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in total cholesterol (TC) in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in triglyceride (TG) in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in fasting blood glucose in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in body fat in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in weight in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in blood pressure in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in low density lipoprotein (LDL) in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in high density lipoprotein (HDL) in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in total cholesterol (TC) in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in triglyceride (TG) in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in fasting blood glucose in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in body fat in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in weight in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Changes in blood pressure in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compared the changes in LDL between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compared the changes in HDL between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compared the changes in TC between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compared the changes in TG between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compared the changes in fasting blood glucose between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compared the changes in body fat between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compared the changes in weight between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Compared the changes in blood pressure between SB and SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Change in resting energy expenditure in SB
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
measure: Change in resting energy expenditure in SR
timeFrame: Baseline (pre-intervention) and 4 weeks (post-intervention)
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University - Department of Nutritional Sciences
state: Texas
Study officials:
References: