WorkWell: Work-based Activity and Metabolic Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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PreDiabetes, Obesity

Intervention / Treatment
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* Behavioral: Standing condition
* Behavioral: Light physical activity (LPA) condition
* Behavioral: Usual behavior condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Move, Stand<br>Usual behavior condition, followed by the standing condition, followed by the LPA condition. | Behavioral: Standing condition<br>* 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.<br>Behavioral: Light physical activity (LPA) condition<br>* 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.<br>Behavioral: Usual behavior condition<br>* 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.<br>|
| Active Comparator: Stand, Move<br>Usual behavior condition, followed by the LPA condition, followed by the standing condition. | Behavioral: Standing condition<br>* 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.<br>Behavioral: Light physical activity (LPA) condition<br>* 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.<br>Behavioral: Usual behavior condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 2-hour postprandial area-under-the-curve blood glucose at 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline workplace standing time at 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. | 2 weeks | 
| Change in baseline workplace stepping time at 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedentary, prediabetes, lifestyle modification, cardiometabolic health