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Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss

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ClinicalTrials.gov Identifier: NCT01461382
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : October 28, 2011
Sponsor:
Information provided by (Responsible Party):
James Levine, Mayo Clinic

October 24, 2011
October 28, 2011
October 28, 2011
May 2008
December 2009   (Final data collection date for primary outcome measure)
Daily Physical Activity [ Time Frame: 1 year ]
Measured for all waking hours using tri-axial accelerometry.
Same as current
No Changes Posted
  • Body Weight [ Time Frame: baseline, 6 months, 12 months ]
  • Body Composition [ Time Frame: baseline, 6 months, 12 months ]
  • Venous blood [ Time Frame: baseline, 6 months, 12 months ]
  • Work performance [ Time Frame: baseline, 6 months, 12 months ]
Same as current
Not Provided
Not Provided
 
Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss
Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss

Is a one-year intervention with Treadmill Desks associated with increased employee daily physical activity and decreased sedentariness.

36 employees with sedentary jobs (87 + 27 kg, BMI 29 + 7 kg/m2) used a Treadmill Desk for one year. Daily Physical Activity, work performance, body composition, and blood variables were measured at Baseline and 6 and 12 months after the Treadmill Desk intervention.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Obesity
  • Other: Treadmill Desks
    Treadmill Desk were installed in subjects personal workspace.
  • Other: Treadmill Desks
    Treadmill desks were installed in subjects personal workspace six months after phase I started.
  • Experimental: Phase I
    Entered Study May 2008.
    Intervention: Other: Treadmill Desks
  • Experimental: Phase II
    Phase II entered 6 months after Phase I. Phase II was a no intervention control for 6 months, then followed an identical intervention protocol to Phase I.
    Intervention: Other: Treadmill Desks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Same as current
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects will be recruited regardless of race/ethnicity.

Exclusion Criteria:

  • Definite termination criteria.

    • Request by subject to leave study.
    • Evidence of deliberate non-compliance (e.g.; placing activity instruments on another individual, deliberate destruction of instruments).
    • Pregnancy.
    • Alcohol abuse; elicit drug abuse.
    • Development of chronic condition that is likely to impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate (e.g., Grave's disease, hypothyroidism, rheumatoid arthritis requiring steroids or limiting mobility, congestive cardiac failure, neurological disorder such as multiple sclerosis or stroke).
    • Development of acute condition that is likely to impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate (e.g., motor vehicle accident with multiple fractures, myocardial infarction, major depression).

Potential termination criteria.

Development of acute or chronic condition that may impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate. Subjects will be reviewed on a subject-by-subject basis and will be reported to the Safety-Monitoring Panel. Specific action plans are pre-assigned for:

  • Diabetes (two fasting plasma glucose values >126 mg/dl). Here, glycosylated hemoglobin will be measured three monthly (by the study) and subjects referred to their local physician for preventative screening. Subjects will be excluded from further study with any glycosylated hemoglobin value of >8% or symptomatic hyperglycemia.
  • Depression or low mood. Here, all patients will be asked to be evaluated by their primary care physician and if appropriate referred to a psychiatrist. The opinion of the psychiatrist will be used to determine continuance or termination in the protocol.

This does not represent a comprehensive listing of criteria or causes. All subjects who withdraw or whom are withdrawn from the study or whom are considering/being considered for withdrawal will be referred to the Safety-Monitoring Panel. These subjects' data will be scrutinized (whether terminated or not) separately to assess for association of intervention with a specific adverse outcome.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01461382
07-003809
No
Not Provided
Not Provided
James Levine, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: James A Levine, MD PhD Mayo Clinic
Mayo Clinic
October 2011

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