WorkWell: Work-based Activity and Metabolic Health

Overview

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 Title of Study: “WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2020

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.

Interventions

  • Behavioral: Standing condition
    • Participants will be asked to stand an additional 6 minutes per hour above their median standing time from the observed time in the usual behavior condition.
  • Behavioral: Light physical activity (LPA) condition
    • Participants will be asked to perform 6 additional minutes per hour above their median LPA time from the observed time in the usual behavior condition.
  • Behavioral: Usual behavior condition
    • Participants will be asked to perform their normal work activities in their normal work environment for one week. There will be no modifications to their work environment or instructions given of what activities to partake in. This period will be used to understand their normal standing and LPA behaviors to determine the personalized changes to their standing and LPA behaviors in the other conditions.

Arms, Groups and Cohorts

  • Active Comparator: Move, Stand
    • Usual behavior condition, followed by the standing condition, followed by the LPA condition.
  • Active Comparator: Stand, Move
    • Usual behavior condition, followed by the LPA condition, followed by the standing condition.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in baseline workplace standing time at 2 weeks
    • Time Frame: 2 weeks
    • Participants will be asked to wear an activPAL acceleometer 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
    • Time Frame: 2 weeks
    • Participants will be asked to wear an activPAL acceleometer 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Men age 50 y and older, women age 50 y and older and post-menopausal for 4 years or longer
  • Holds a job where primary work activities are done seated
  • Works in an office location (i.e., outside the home) 4 or more days/week
  • A BMI ≥ 27.5 and ≤40 kg/m2
  • HbA1c of 5.7 to 7.5%

Exclusion Criteria

  • HbA1c > 7.5 or < 5.7%
  • Currently taking diabetes medication
  • Participants with Type 2 Diabetes (T2D) and HbA1c of 6.5%-7.5% will be evaluated by the study physician on a case-by-case basis to determine participation safety.
  • Taking any of the following medications or treatments:
  • Medication to control high blood pressure
  • Medication to treat high blood glucose
  • Blood thinners
  • Hormone replacement therapy (in the past 12 months)
  • Corticosteroids
  • High dose statins (Study 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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Arizona State University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Matthew Buman, PhD, (602)827-2289, matthew.buman@asu.edu

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