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General PopulationNCT03609255

Health Effects of Reducing Sedentary Behavior

A study testing Reducing sedentary behavior and Reducing stress in people with General Population, run by Texas Tech University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
General Population
What is being tested?
Reducing sedentary behavior and Reducing stress
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
13 Aug 2018to 8 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age: 18-65 years.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Tech University - Department of Nutritional Sciences

    Lubbock, Texas, 79409

Other trials in United States

About this study

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.

Being tested
Reducing sedentary behavior, Reducing stress, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reducing sedentary behaviorBehavioural

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

  • Reducing stressBehavioural

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

  • ControlBehavioural

    An educational handout for sedentary behavior and weekly neutral topic videos

Study groups in NCT03609255
Study groupRoleWhat they receive
Control group (C)Active comparatorNot described
Receives: Behavioral: Control
Sedentary behavior group (SB)ExperimentalNot described
Receives: Behavioral: Reducing sedentary behavior
Stress management group (SR)ExperimentalNot described
Receives: Behavioral: Reducing stress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily steps

    Changes in daily steps measured via pedometer.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  2. Stress improvement in sedentary behavior group (SB)

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  3. Stress improvement in sedentary behavior group (SB)

    Improvement in stress as measured via salivary cortisol in SB.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  4. Stress improvement in stress management group (SR)

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  5. Stress improvement in stress management group (SR)

    Improvement in stress as measured via salivary cortisol in SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  6. 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.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  7. 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.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

Secondary outcomes (26)

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

    Changes in LDL as measured via finger stick in SB.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

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

    Changes in HDL as measured via finger stick in SB.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  3. Changes in total cholesterol (TC) in SB

    Changes in TC as measured via finger stick in SB.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  4. Changes in triglyceride (TG) in SB

    Changes in TG as measured via finger stick in SB.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  5. Changes in fasting blood glucose in SB

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  6. Changes in body fat in SB

    Changes in body fat as measured via BODPOD in SB.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  7. Changes in weight in SB

    Changes in weight as measured via BODPOD in SB.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  8. Changes in blood pressure in SB

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

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

    Changes in LDL as measured via finger stick in SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

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

    Changes in HDL as measured via finger stick in SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  11. Changes in total cholesterol (TC) in SR

    Changes in TC as measured via finger stick in SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  12. Changes in triglyceride (TG) in SR

    Changes in TG as measured via finger stick in SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  13. Changes in fasting blood glucose in SR

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  14. Changes in body fat in SR

    Changes in body fat as measured via BODPOD in SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  15. Changes in weight in SR

    Changes in weight as measured via BODPOD in SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  16. Changes in blood pressure in SR

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  17. Compared the changes in LDL between SB and SR

    Compared the changes in LDL between SB and SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  18. Compared the changes in HDL between SB and SR

    Compared the changes in HDL between SB and SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  19. Compared the changes in TC between SB and SR

    Compared the changes in TC between SB and SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  20. Compared the changes in TG between SB and SR

    Compared the changes in TG between SB and SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

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

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

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

    Compared the changes in body fat between SB and SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  23. Compared the changes in weight between SB and SR

    Compared the changes in weight between SB and SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

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

    Compared the changes in blood pressure between SB and SR.

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  25. Change in resting energy expenditure in SB

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

  26. Change in resting energy expenditure in SR

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

    Measured: Baseline (pre-intervention) and 4 weeks (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start13 Aug 2018
  3. Primary completion8 Oct 2018
  4. Study completion8 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03609255
Sponsor's protocol ID
TTUIRB2018-347
Status last verified
Oct 2018
First submitted
16 Jul 2018
Last updated
24 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Reducing sedentary behavior and Reducing stress in people with General Population, run by Texas Tech University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily steps (time frame: Baseline (pre-intervention) and 4 weeks (post-intervention)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03609255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018; AzTrials last refreshed its copy on 30 Oct 2026.

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