WorkWell: Work-based Activity and Metabolic Health

Arizona State University (ASU)

Status: Completed

Conditions: Obesity; PreDiabetes

Treatments: Behavioral: Standing condition; Behavioral: Usual behavior condition; Behavioral: Light physical activity (LPA) condition

Study type: Interventional

Funder types: Other

Identifiers

NCT04269070

STUDY00010172

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Move, Stand

Active Comparator group

Description:

Usual behavior condition, followed by the standing condition, followed by the LPA condition.

Treatment:

Behavioral: Standing condition

Behavioral: Usual behavior condition

Behavioral: Light physical activity (LPA) condition

Stand, Move

Active Comparator group

Description:

Usual behavior condition, followed by the LPA condition, followed by the standing condition.

Treatment:

Behavioral: Standing condition

Behavioral: Usual behavior condition

Behavioral: Light physical activity (LPA) condition