WorkWell: Work-based Activity and Metabolic Health
- Conditions
- PreDiabetesObesity
- Interventions
- Behavioral: Standing conditionBehavioral: Light physical activity (LPA) conditionBehavioral: Usual behavior condition
- Registration Number
- NCT04269070
- Lead Sponsor
- Arizona State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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)
-
Currently taking diabetes medication
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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
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History of inflammatory bowel or intestinal malabsorption conditions
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Use of prebiotics, probiotics or antibiotics in the last 3 months
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Serious food allergies or restrictions
-
Participants who will be travelling 3 or more days out of their typical week
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Stand, Move Light physical activity (LPA) condition Usual behavior condition, followed by the LPA condition, followed by the standing condition. Move, Stand Standing condition Usual behavior condition, followed by the standing condition, followed by the LPA condition. Move, Stand Light physical activity (LPA) condition Usual behavior condition, followed by the standing condition, followed by the LPA condition. Stand, Move Standing condition Usual behavior condition, followed by the LPA condition, followed by the standing condition. Move, Stand Usual behavior condition Usual behavior condition, followed by the standing condition, followed by the LPA condition. Stand, Move Usual behavior condition Usual behavior condition, followed by the LPA condition, followed by the standing condition.
- Primary Outcome Measures
Name Time Method Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks 2 weeks Participants will be asked to wear the Abbott Freestyle Libre continuous glucose monitor during the usual behavior condition (week 1) and both experimental conditions (weeks 2-3 and weeks 5-6). Research staff will insert the CGM sensor at the screening and study visits. The training for this insertion will be conducted by a registered research nurse. The CGM sensors have been designed and tested to be worn continuously for up to 14 days. Sensors will be placed and removed by trained research staff at appropriate time-points throughout the study. Postprandial period will follow a standardize lunch meal. Area-under-the-curve calculations will be based on 2 hours following delivery of this lunch meal.
- Secondary Outcome Measures
Name Time Method Change in baseline workplace standing time at 2 weeks 2 weeks Participants will be asked to wear an activPAL accelerometer throughout the entire intervention period. Data from the devices will be downloaded at each study visit. The activPAL device is worn on the right thigh and is equipped with low energy Bluetooth and will communicate wirelessly with the provided smartphone application to provide feedback to the participant and compliance with the protocol. Workplace time will be assessed by a self-report log and activPAL time will be extracted based on these reports.
Change in baseline workplace stepping time at 2 weeks 2 weeks Participants will be asked to wear an activPAL accelerometer throughout the entire intervention period. Data from the devices will be downloaded at each study visit. The activPAL device is worn on the right thigh and is equipped with low energy Bluetooth and will communicate wirelessly with the provided smartphone application to provide feedback to the participant and compliance with the protocol. Workplace time will be assessed by a self-report log and activPAL time will be extracted based on these reports.
Trial Locations
- Locations (1)
Arizona State University
🇺🇸Tempe, Arizona, United States