WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PreDiabetes
- Sponsor
- Arizona State University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks
Time Frame: 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 Outcomes
- Change in baseline workplace standing time at 2 weeks(2 weeks)
- Change in baseline workplace stepping time at 2 weeks(2 weeks)