Health Effects of Reducing Sedentary Behavior

NCT03609255 | Completed

• 1 other identifier: TTUIRB2018-347
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

General Population

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (26)

• Changes in low density lipoprotein (LDL) in SB

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

• Changes in high density lipoprotein (HDL) in SB

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

• Changes in total cholesterol (TC) in SB

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

• Changes in triglyceride (TG) in SB

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

• Changes in fasting blood glucose in SB

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

Study Arms (3)

Control group (C)

ACTIVE COMPARATOR

Behavioral: Control

Sedentary behavior group (SB)

EXPERIMENTAL

Behavioral: Reducing sedentary behavior

Stress management group (SR)

EXPERIMENTAL

Behavioral: Reducing stress

Interventions

Reducing sedentary behavior BEHAVIORAL

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

Sedentary behavior group (SB)

Reducing stress BEHAVIORAL

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

Stress management group (SR)

Control BEHAVIORAL

An educational handout for sedentary behavior and weekly neutral topic videos

Control group (C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 1, 2018
• Study Start: August 13, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

US (1)