Sedentary LifestyleNCT03816150
Reduce Sedentary Behavior at Work
An observational study of Sedentary Lifestyle and Obesity, run by Medical College of Wisconsin.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sedentary Lifestyle, Obesity, Cardiovascular Risk Factor
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2016to 30 Nov 2020
- Phase
- Observational
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
Official title: Interventions to Reduce Sedentary Behavior at Work: Pilot Study
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.
Read the detailed description
The hypothesis is that obese subjects with sedentary jobs at the Medical College of Wisconsin, when assigned use of a standing desk to encourage movement, will reduce their daily sedentary time and demonstrate improvement in physiologic parameters and disease markers from baseline through the end of the intervention.
Prior intervention studies are limited and not randomized, but have shown a reduction in waist circumference and improvements in cholesterol when overall sitting time is reduced over a 3-6 month interval (with a standing or treadmill desk). None of these intervention studies have directly measured vascular endothelial function, as assessed by arterial flow-mediated dilation (FMD), an early indicator of cardiovascular disease, and a powerful predictor of future cardiovascular events and vascular inflammation. Improvements in arterial FMD (or endothelial function) are known to reduce the future risk of cardiovascular events.
Due to differences in the energy requirement of lying down, sitting, and standing, there has been increased research interest in activity type classification based on posture. In the science of sedentary behaviors, this is an important distinction to consider when evaluating health outcomes, such as in the present study. Accelerometers (physical activity monitors) utilize piezoelectric crystal sensor technology to provide a measure of accelerations of the body during movement and have the advantage of capturing frequency, duration, and intensity of physical movement minute by minute. Accelerometer technology will be used to analyze the primary outcome of interest (sedentary time). The study team will collect information on standing time, sedentary bouts, daily steps, cadence (walking speed in steps/minute), and exercise activity. The study team will employ a compact and re-usable physical activity monitor that adheres to the subject's thigh. This will provide objective assessments of activity levels at baseline and during the intervention. This data can be translated into energy expenditure or activity intensity categories (METs) and even position (sitting verses standing). The monitor output is Excel-compatible and is ideal for comparing each subject's activity and physiological parameters from baseline to intervention.
- Conditions
- Sedentary Lifestyle, Obesity, Cardiovascular Risk Factor
- Medical subject headings
- Sedentary Behavior, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from baseline sedentary behaviors after 6 months
Secondary outcomes (6)
The Impact of reducing sedentary time on physiological outcomes
Measure Flow Mediated Dilation (FMD)
Measured: 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
Measure Near-infrared spectroscopy is a spectroscopic (NIRS)
Measured: 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
anthropometrics: Change from baseline body mass index after use of a standing desk
Measured: Through study completion, an average of 6 months
The Impact of reducing sedentary time on physiological outcomes
measure cardiac hemodynamics: Change from baseline systolic and diastolic blood pressure after use of a standing desk,
Measured: Through study completion, an average of 6 months
The Impact of reducing sedentary time on physiological outcomes
measure cardiac hemodynamics: Change from heart rate after use of a standing desk,
Measured: Through study completion, an average of 6 months
The Impact of reducing sedentary time on physiological outcomes
Measure blood lab results: Change from baseline fasting lipids, insulin resistance, hemoglobin A1c and C-reactive protein (CRP)
Measured: At baseline after use of a standing desk, through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start13 Jun 2016
- Primary completion18 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacquelyn Kulinski, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816150
- Sponsor's protocol ID
- 25912
- Status last verified
- Sep 2021
- First submitted
- 17 Jan 2019
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Reduce Sedentary Behavior at Work: Pilot Study
- ClinicalTrials.gov ID
- NCT03816150
- Acronym / sponsor ID
- 25912
- Conditions
- Sedentary Lifestyle, Obesity, Cardiovascular Risk Factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The hypothesis is that obese subjects with sedentary jobs at the Medical College of Wisconsin, when assigned use of a standing desk to encourage movement, will reduce their daily sedentary time and demonstrate improvement in physiologic parameters and disease markers from baseline through the end of the intervention.
Prior intervention studies are limited and not randomized, but have shown a reduction in waist circumference and improvements in cholesterol when overall sitting time is reduced over a 3-6 month interval (with a standing or treadmill desk). None of these intervention studies have directly measured vascular endothelial function, as assessed by arterial flow-mediated dilation (FMD), an early indicator of cardiovascular disease, and a powerful predictor of future cardiovascular events and vascular inflammation. Improvements in arterial FMD (or endothelial function) are known to reduce the future risk of cardiovascular events.
Due to differences in the energy requirement of lying down, sitting, and standing, there has been increased research interest in activity type classification based on posture. In the science of sedentary behaviors, this is an important distinction to consider when evaluating health outcomes, such as in the present study. Accelerometers (physical activity monitors) utilize piezoelectric crystal sensor technology to provide a measure of accelerations of the body during movement and have the advantage of capturing frequency, duration, and intensity of physical movement minute by minute. Accelerometer technology will be used to analyze the primary outcome of interest (sedentary time). The study team will collect information on standing time, sedentary bouts, daily steps, cadence (walking speed in steps/minute), and exercise activity. The study team will employ a compact and re-usable physical activity monitor that adheres to the subject's thigh. This will provide objective assessments of activity levels at baseline and during the intervention. This data can be translated into energy expenditure or activity intensity categories (METs) and even position (sitting verses standing). The monitor output is Excel-compatible and is ideal for comparing each subject's activity and physiological parameters from baseline to intervention.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: through study completion, an average of 6 months
Ten Questions using a Likert Scale. Each question has the same 5 options: strongly agree, agree, neutral, disagree, strongly disagree.
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
Time frame: Change from baseline sedentary behaviors after 6 months
Objectively quantify sitting, standing and walking times (sedentary vs. non-sedentary) using an accelerometer device that adheres to the subjects thigh
6 secondary outcomes
The Impact of reducing sedentary time on physiological outcomes
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 6 months
The Impact of reducing sedentary time on physiological outcomes
Time frame: Through study completion, an average of 6 months
The Impact of reducing sedentary time on physiological outcomes
Time frame: Through study completion, an average of 6 months
The Impact of reducing sedentary time on physiological outcomes
Time frame: At baseline after use of a standing desk, through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary Lifestyle and Obesity, run by Medical College of Wisconsin.
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 4 inclusion and 12 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 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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 (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2021.