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Completed

NCT Number: NCT03609255

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.

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Key information

Conditions

General Population

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reducing Sedentary Behavior

Behavioral

Educational handouts for sedentary behavior and strategies reducing sedentary behavior and weekly videos related to reduced sedentary behavior

Reducing stress

Behavioral

Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management

Control

Behavioral

An educational handout for sedentary behavior and weekly neutral topic videos

Primary outcomes

  1. Daily steps

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in daily steps measured via pedometer.

  2. Stress improvement in sedentary behavior group (SB)

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Improvement in stress as measured via Perceived Stress Scale (PSS) in SB.

  3. Stress improvement in sedentary behavior group (SB)

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Improvement in stress as measured via salivary cortisol in SB.

  4. Stress improvement in stress management group (SR)

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Improvement in stress as measured via Perceived Stress Scale (PSS) in SR.

  5. Stress improvement in stress management group (SR)

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Improvement in stress as measured via salivary cortisol in SR.

  6. Compare the changes of stress levels between SB and SR

    Time frame: 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.

  7. Compare the changes of stress levels between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compare the changes of stress levels as measured via salivary cortisol between SB and SR.

Secondary outcomes

  1. Changes in low density lipoprotein (LDL) in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in LDL as measured via finger stick in SB.

  2. Changes in high density lipoprotein (HDL) in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in HDL as measured via finger stick in SB.

  3. Changes in total cholesterol (TC) in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in TC as measured via finger stick in SB.

  4. Changes in triglyceride (TG) in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in TG as measured via finger stick in SB.

  5. Changes in fasting blood glucose in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in fasting blood glucose as measured via finger stick in SB.

  6. Changes in body fat in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in body fat as measured via BODPOD in SB.

  7. Changes in weight in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in weight as measured via BODPOD in SB.

  8. Changes in blood pressure in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in blood pressure as measured via Omron Digital BP Monitor HEM-907XL in SB.

  9. Changes in low density lipoprotein (LDL) in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in LDL as measured via finger stick in SR.

  10. Changes in high density lipoprotein (HDL) in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in HDL as measured via finger stick in SR.

  11. Changes in total cholesterol (TC) in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in TC as measured via finger stick in SR.

  12. Changes in triglyceride (TG) in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in TG as measured via finger stick in SR.

  13. Changes in fasting blood glucose in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in fasting blood glucose as measured via finger stick in SR.

  14. Changes in body fat in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in body fat as measured via BODPOD in SR.

  15. Changes in weight in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in weight as measured via BODPOD in SR.

  16. Changes in blood pressure in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Changes in blood pressure as measured via Omron Digital BP Monitor HEM-907XL in SR.

  17. Compared the changes in LDL between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compared the changes in LDL between SB and SR.

  18. Compared the changes in HDL between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compared the changes in HDL between SB and SR.

  19. Compared the changes in TC between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compared the changes in TC between SB and SR.

  20. Compared the changes in TG between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compared the changes in TG between SB and SR.

  21. Compared the changes in fasting blood glucose between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compared the changes in fasting blood glucose between SB and SR.

  22. Compared the changes in body fat between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compared the changes in body fat between SB and SR.

  23. Compared the changes in weight between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compared the changes in weight between SB and SR.

  24. Compared the changes in blood pressure between SB and SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Compared the changes in blood pressure between SB and SR.

  25. Change in resting energy expenditure in SB

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Change in resting energy expenditure as measured by metabolic cart in SB.

  26. Change in resting energy expenditure in SR

    Time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)

    Change in resting energy expenditure as measured by metabolic cart in SR.

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2018
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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