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Stand & Move at Work

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ClinicalTrials.gov Identifier: NCT02566317
Recruitment Status : Completed
First Posted : October 2, 2015
Results First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
University of Minnesota
Information provided by (Responsible Party):
Arizona State University

Tracking Information
First Submitted Date  ICMJE September 22, 2015
First Posted Date  ICMJE October 2, 2015
Results First Submitted Date  ICMJE July 15, 2019
Results First Posted Date  ICMJE October 11, 2019
Last Update Posted Date October 11, 2019
Actual Study Start Date  ICMJE January 15, 2016
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Mean Change in Light-intensity Physical Activity at Work From Baseline to 12 Months [ Time Frame: 1 year ]
    Measured via 7d of activPAL accelerometry (value at 12 months minus value at baseline)
  • Mean Change in Sitting Time at Work From Baseline to 12 Months [ Time Frame: 1 year ]
    Measured via 7d of activPAL accelerometry (value at 12 months minus value at baseline)
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • Light-intensity physical activity at work [ Time Frame: 1 year ]
    Measured via 7d of activPAL accelerometry
  • Sitting time at work [ Time Frame: 1 year ]
    Measured via 7d of activPAL accelerometry
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
Clustered Metabolic Risk Score From Baseline to 12 Months [ Time Frame: 1 year ]
Clustered metabolic risk score (fasting glucose, insulin, triglycerides, HDL-cholesterol, blood pressure); value at 12 months minus value at baseline; higher scores indicate better outcome. The Z-score for each component (fasting glucose, insulin, triglycerides, HDL-cholesterol, blood pressure) based on the baseline mean and standard deviation of the entire group was computed and summed for each participant (HDL z-score was subtracted rather than added). The sum of these z-scores represents the metabolic risk score.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Cardiometabolic risk [ Time Frame: 1 year ]
Clustered metabolic risk score (fasting glucose, insulin, triglycerides, HDL-cholesterol, blood pressure)
Current Other Pre-specified Outcome Measures
 (submitted: January 24, 2017)
  • Sleep Substudy [ Time Frame: 1 year ]
    24h wrist accelerometry in individuals with minor-moderate sleep complaints
  • Ambulatory Blood Pressure [ Time Frame: 3 months ]
    Dynamic changes in ambulatory blood pressure in prehypertensives
  • Ecological Momentary Assessment of Mood [ Time Frame: 1 year ]
    Periodic monitoring of mood, energy, fatigue in smartphone users
  • Dynamic Glucose Control [ Time Frame: 3 months ]
    Continuous glucose monitoring in prediabetics
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stand & Move at Work
Official Title  ICMJE Stand & Move at Work: A Group Randomized Trial
Brief Summary A trial testing the efficacy of sit-stand workstations on decreasing sitting time and increasing light-intensity physical activity in samples of office worksites.
Detailed Description With traditional approaches to increasing MVPA (moderate to vigorous physical activity) in the workplace being unsustainable due to the requirement of deliberate and dedicated time away from work, this group-randomized trial will test the efficacy of sit-stand workstations on decreasing sitting time and increasing light-intensity physical activity (LPA) in a highly generalizable sample of office worksites using a multi-level intervention with high potential for dissemination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Hypertension
  • Diabetes
Intervention  ICMJE
  • Device: Sit-Stand workstation
    Installation of a sit-stand desk at work
  • Behavioral: Move
    A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace
Study Arms  ICMJE
  • Active Comparator: Move
    A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace.
    Intervention: Behavioral: Move
  • Experimental: Stand & Move
    Move intervention (A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace) plus the installation of a sit-stand workstation.
    Interventions:
    • Device: Sit-Stand workstation
    • Behavioral: Move
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2019)
630
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
720
Actual Study Completion Date  ICMJE December 15, 2018
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Worksite-level inclusion criteria:

  • Size: Small to moderate size worksite (20-60 employees)
  • Schedule: >80% of employees full time
  • Occupation: Seated office work, primarily computer- and- telephone-based work, little movement or walking
  • Wellness environment: Not currently undergoing a wellness program aimed at increasing activity at work
  • Workstations: Willing to have sit-stand workstations installed at a worksite
  • Willing to be randomized: Willing to be randomized to either intervention conditions

Member-level inclusion criteria:

  • Age: 18 years and older
  • Health status: Generally good health and able to safely increase LPA and reduce sitting time
  • Employment status: Any sedentary job, sitting most of the say, little standing or walking
  • Occupation: Traditional sitting desk, willing to have a sit-stand workstation installed at desk
  • Workstation: traditional sitting desk;willing to have a sit-stand workstation installed at desk

Exclusion Criteria:

  • contraindication to prolonged standing at work
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02566317
Other Study ID Numbers  ICMJE R01CA198971( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE University of Minnesota
Investigators  ICMJE
Principal Investigator: Matthew P Buman, PhD Arizona State University
Principal Investigator: Mark A Pereira, PhD University of Minnesota
PRS Account Arizona State University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP