Clinical trial NCT04269070: WorkWell: Work-based Activity and Metabolic Health
Official title: WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Keywords: sedentary
prediabetes
lifestyle modification
cardiometabolic health
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a crossover trial where study participants will experience two conditions following a baseline usua behavior conditions. All study participants will experience each of the conditions: a standing condition, and a light intensity physical activity (LPA) intervention.
Primary purpose: OTHER

Brief summary: This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments.

Detailed description: This pilot study is being conducted to determine whether a range of pre-clinical cardiometabolic biomarkers (measured via gut microbiome, blood draw) can be improved via regular intervals of standing and light-intensity physical activity (i.e., leisurely walking) in real-world office environments. This trial is meant to generate pilot data which will lead to additional clinical trials.

Primary Hypothesis: Increasing both standing and light-intensity physical activity will improve biomarkers of metabolic function, as measured by blood metabolites and differential abundance of gut microbiome composition, compared to a control condition of normal workplace behavior.

Eligibility criteria: Inclusion Criteria:

* Women and men age 18 yrs and older
* Holds a job where primary work activities are done seated
* Has the space and ability to use a sit-to-stand workstation in their primary workspace
* Works in an office setting or remotely for ≥ 4 days per week
* Have a BMI ≥ 25.0 (≥23.0 for individuals of Asian descent)

Exclusion Criteria:

* Currently taking diabetes medication
* Taking any of the following medications or treatments:

  * Medication to control high blood pressure
  * Medication to treat high glucose
  * Blood thinners
  * Hormone replacement therapy (in the past 12 months)
  * Corticosteroids
  * High dose statins (Dr. Reaven, MD to adjudicate eligibility based on dosage)
  * 2nd generation antipsychotics
* Current or previous foot or lower limb injuries
* Current use of sit-stand workstation
* Current smoker
* Neuromuscular or cardiovascular disorders or other serious active medical issues, including deep vein thrombosis or respiratory issues
* Has a physical impairment or musculoskeletal condition that will prevent the subject from standing or light-intensity walking for a maximum of 30 minutes
* Has been advised to avoid prolonged periods of sitting or standing by a physician or other healthcare provider
* History of inflammatory bowel or intestinal malabsorption conditions
* Use of prebiotics, probiotics or antibiotics in the last 3 months
* Serious food allergies or restrictions
* Participants who will be travelling 3 or more days out of their typical week

Primary outcomes:
measure: Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in baseline workplace standing time at 2 weeks
timeFrame: 2 weeks
measure: Change in baseline workplace stepping time at 2 weeks
timeFrame: 2 weeks
Other outcomes:
measure: Treatment acceptability/satisfaction
timeFrame: 2 weeks
measure: Change in fasting blood glucose at 2 weeks
timeFrame: 2 weeks
measure: Change in femoral artery reactivity at 2 weeks
timeFrame: 2 weeks
measure: Change in central aortic diastolic and systolic blood pressure at 2 weeks
timeFrame: 2 weeks
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: