Health Effects of Reducing Sedentary Behavior

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.

Study Overview

• Status: Completed
• Conditions: General Population
• Intervention / Treatment: Behavioral: Control; Behavioral: Reducing sedentary behavior; Behavioral: Reducing stress

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79409
      • Texas Tech University - Department of Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group (C)	Behavioral: Control; An educational handout for sedentary behavior and weekly neutral topic videos
Experimental: Sedentary behavior group (SB)	Behavioral: Reducing sedentary behavior; Educational handouts for sedentary behavior and strategies reducing sedentary behavior and weekly videos related to reduced sedentary behavior
Experimental: Stress management group (SR)	Behavioral: Reducing stress; Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily steps	Changes in daily steps measured via pedometer.	Baseline (pre-intervention) and 4 weeks (post-intervention)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Changes in triglyceride (TG) in SB	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	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	Changes in body fat as measured via BODPOD in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in weight in SB	Changes in weight as measured via BODPOD in SB.	Baseline (pre-intervention) and 4 weeks (post-intervention)
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)
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)
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)
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)
Changes in triglyceride (TG) in SR	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	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	Changes in body fat as measured via BODPOD in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
Changes in weight in SR	Changes in weight as measured via BODPOD in SR.	Baseline (pre-intervention) and 4 weeks (post-intervention)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Texas Tech University

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): October 8, 2018
• Study Completion (Actual): October 8, 2018

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: TTUIRB2018-347

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No