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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Levine, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01461382
First received: October 24, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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 Intervention
Obesity
Other: Treadmill Desks

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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


Secondary Outcome Measures:
  • Body Weight [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Venous blood [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Work performance [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: James Levine, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01461382     History of Changes
Other Study ID Numbers: 07-003809
Study First Received: October 24, 2011
Last Updated: October 27, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014