WorkWell: Work-based Activity and Metabolic Health
WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
March 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedMay 10, 2023
May 1, 2023
2.1 years
January 3, 2020
May 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in baseline workplace standing time at 2 weeks
2 weeks
Change in baseline workplace stepping time at 2 weeks
2 weeks
Other Outcomes (4)
Treatment acceptability/satisfaction
2 weeks
Change in fasting blood glucose at 2 weeks
2 weeks
Change in femoral artery reactivity at 2 weeks
2 weeks
- +1 more other outcomes
Study Arms (2)
Move, Stand
ACTIVE COMPARATORUsual behavior condition, followed by the standing condition, followed by the LPA condition.
Stand, Move
ACTIVE COMPARATORUsual behavior condition, followed by the LPA condition, followed by the standing condition.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
- nd 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona State University
Tempe, Arizona, 85281, United States
Related Publications (1)
Wilson SL, Crosley-Lyons R, Junk J, Hasanaj K, Larouche ML, Hollingshead K, Gu H, Whisner C, Sears DD, Buman MP. Effects of Increased Standing and Light-Intensity Physical Activity to Improve Postprandial Glucose in Sedentary Office Workers: Protocol for a Randomized Crossover Trial. JMIR Res Protoc. 2023 Aug 23;12:e45133. doi: 10.2196/45133.
PMID: 37610800DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Flow-mediated dilation outcome: Images that are obtained will be analyzed by a blinded researcher using a previously validated, edge-detection software
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2020
First Posted
February 13, 2020
Study Start
March 25, 2021
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
May 10, 2023
Record last verified: 2023-05