NCT03816150

Brief Summary

Prior research suggests that sedentary behavior is detrimental to health, independent of exercise activity. Sedentary behavior is defined as behaviors that involve low levels of energy expenditure ≤1.5 metabolic equivalents (including sitting, watching TV, reading, and driving). Due to the high burden of sedentary behaviors in modern-day societies, this has potential implications for novel intervention strategies to reduce sitting (outside of regular exercise activity) and improve health. In addition, the modern workplace fosters sedentary behavior, and sedentary jobs now make up more than 80% of the workforce. The goal of this project is to implement interventions to reduce sedentary behavior at work and evaluate their impact on physiologic parameters and markers of disease. Specifically, the investigators/study team will use direct measurement of vascular endothelial function as one of our outcomes. This is important since conduit artery endothelial function, assessed by arterial flow-mediated dilation (FMD), is a powerful indicator of vascular inflammation and predictor of future cardiovascular events.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

4.3 years

First QC Date

January 17, 2019

Last Update Submit

September 24, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • The feasibility of implementing workplace interventions to reduce sedentary time, specifically using a sit-stand desk. We will survey the subjects regarding the feasibility and likability of the sit-stand workstation

    Ten Questions using a Likert Scale. Each question has the same 5 options: strongly agree, agree, neutral, disagree, strongly disagree.

    through study completion, an average of 6 months

  • The feasibility of implementing workplace interventions to reduce sedentary time, specifically using a sit-stand desk. We will survey the subjects regarding the feasibility and likability of the sit-stand workstation

    Objectively quantify sitting, standing and walking times (sedentary vs. non-sedentary) using an accelerometer device that adheres to the subjects thigh

    Change from baseline sedentary behaviors after 6 months

Secondary Outcomes (6)

  • The Impact of reducing sedentary time on physiological outcomes

    Change from baseline after use of a standing desk, through study completion, an average of 6 months

  • The Impact of reducing sedentary time on physiological outcomes

    Change from baseline after use of a standing desk, through study completion, an average of 6 months

  • The Impact of reducing sedentary time on physiological outcomes

    Through study completion, an average of 6 months

  • The Impact of reducing sedentary time on physiological outcomes

    Through study completion, an average of 6 months

  • The Impact of reducing sedentary time on physiological outcomes

    Through study completion, an average of 6 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Sedentary office workers at the Medical College of Wisconsin who spend greater than 75% of their (8 hours or longer) work-day sitting at a desk.

You may qualify if:

  • Sedentary office workers the Medical College of Wisconsin who spend greater than 75% of their (8 hours or longer) work-day sitting at a desk. This includes at least 1 period of 2 hours or longer of uninterrupted sitting time per work day.
  • Body mass index of 26.0-44.9
  • Willing and able to sign Informed consent
  • Permission from the subject's supervisor to participate in the intervention

You may not qualify if:

  • Known history of atherosclerotic cardiovascular disease, including myocardial infarction, stroke, coronary stent, coronary artery bypass grafting, angina and peripheral vascular disease
  • Diabetics on insulin or other diabetic medications (pre-diabetes would be acceptable, defined as a HbgA1c of 5.7 to 6.4%, and not on medications)
  • Elevated blood pressure (SBP≥150 mm Hg or DBP ≥90 mm Hg) or on medication for hypertension; or SBP \< 100 mm Hg.
  • On cholesterol-lowering medication or LDL-C cholesterol ≥190 mg/dL
  • Pregnancy, lactating or planning to get pregnant within the next 6 months
  • Current tobacco use within previous 12 months. Tobacco use included cigarettes, cigars, and all forms of smokeless tobacco.
  • Current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
  • Current illicit drug use, defined as overuse of prescription medications, or of any illegal mind altering substances.
  • Known thyroid disease
  • Taking diet pills, or supplements other than those contained in a multi-vitamin
  • History of musculoskeletal surgery/injury that would interfere with prolonged periods of standing
  • History of use of PDE-5 inhibitors for any reason within the last 5 days of screening visit, and the inability to hold use of PDE-5 inhibitors for 5 days prior to each of the FMD evaluations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood (10 ml) and urine (10cc)

MeSH Terms

Conditions

Sedentary BehaviorObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 25, 2019

Study Start

June 13, 2016

Primary Completion

September 18, 2020

Study Completion

November 30, 2020

Last Updated

September 30, 2021

Record last verified: 2021-09