Back to resultsWorkWell: Work-based Activity and Metabolic Health
Primary Purpose
PreDiabetes, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standing condition
Light physical activity (LPA) condition
Usual behavior condition
Sponsored by
About this trial
This is an interventional other trial for PreDiabetes focused on measuring sedentary, prediabetes, lifestyle modification, cardiometabolic health
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
- 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
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Move, Stand
Stand, Move
Arm Description
Usual behavior condition, followed by the standing condition, followed by the LPA condition.
Usual behavior condition, followed by the LPA condition, followed by the standing condition.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04269070
Brief Title
WorkWell: Work-based Activity and Metabolic Health
Official Title
WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Obesity
Keywords
sedentary, prediabetes, lifestyle modification, cardiometabolic health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
Flow-mediated dilation outcome: Images that are obtained will be analyzed by a blinded researcher using a previously validated, edge-detection software
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Move, Stand
Arm Type
Active Comparator
Arm Description
Usual behavior condition, followed by the standing condition, followed by the LPA condition.
Arm Title
Stand, Move
Arm Type
Active Comparator
Arm Description
Usual behavior condition, followed by the LPA condition, followed by the standing condition.
Intervention Type
Behavioral
Intervention Name(s)
Standing condition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Light physical activity (LPA) condition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual behavior condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in baseline workplace standing time at 2 weeks
Description
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.
Time Frame
2 weeks
Title
Change in baseline workplace stepping time at 2 weeks
Description
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.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Treatment acceptability/satisfaction
Description
Intervention acceptability questionnaire at the end of each condition will elicit each participant's perceived acceptability of the intervention.
Time Frame
2 weeks
Title
Change in fasting blood glucose at 2 weeks
Description
After verifying fasting for 10-12 hours, a blood sample (about 15 ml, approximately 1 tablespoon) will be collected via venipuncture to measure markers of glucose. After withdrawal, blood will be centrifuged at 1,100 x g at 4°C for 20 minutes, and serum, plasma and erythrocytes will be aliquoted and stored at -80 degrees Celsius for subsequent analysis upon sample collection completion. Blood will be drawn by Arizona Biomedical Collaborative Laboratory clinical staff.
Time Frame
2 weeks
Title
Change in femoral artery reactivity at 2 weeks
Description
Femoral Artery Flow Mediated Dilation (FAFMD) Endothelium-dependent dilation of the femoral artery will be measured using B-mode ultrasound (Terason uSmart 3300+™, Burlington MA) using guidelines set forth by the Brachial Artery Reactivity Task Force.
Time Frame
2 weeks
Title
Change in central aortic diastolic and systolic blood pressure at 2 weeks
Description
All participants will lay down in a dimly lit room and have resting blood pressure measured using an automated blood pressure machine. Thereafter, an appropriately sized blood pressure cuff will be placed on the left arm and central and peripheral blood pressures will be assessed using the non-invasive SphygmoCor system.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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WorkWell: Work-based Activity and Metabolic Health
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