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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

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Other: Treadmill Desks Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss
Study Start Date : May 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase I
Entered Study May 2008.
Other: Treadmill Desks
Treadmill Desk were installed in subjects personal workspace.

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.
Other: Treadmill Desks
Treadmill desks were installed in subjects personal workspace six months after phase I started.




Primary Outcome Measures :
  1. Daily Physical Activity [ Time Frame: 1 year ]
    Measured for all waking hours using tri-axial accelerometry.


Secondary Outcome Measures :
  1. Body Weight [ Time Frame: baseline, 6 months, 12 months ]
  2. Body Composition [ Time Frame: baseline, 6 months, 12 months ]
  3. Venous blood [ Time Frame: baseline, 6 months, 12 months ]
  4. Work performance [ Time Frame: baseline, 6 months, 12 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461382


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: James A Levine, MD PhD Mayo Clinic

Responsible Party: James Levine, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01461382     History of Changes
Other Study ID Numbers: 07-003809
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms