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

October 27, 2011 updated by: James Levine, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I
Entered Study May 2008.
Treadmill Desk were installed in subjects personal workspace.
Treadmill desks were installed in subjects personal workspace six months after phase I started.
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.
Treadmill Desk were installed in subjects personal workspace.
Treadmill desks were installed in subjects personal workspace six months after phase I started.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Physical Activity
Time Frame: 1 year
Measured for all waking hours using tri-axial accelerometry.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Weight
Time Frame: baseline, 6 months, 12 months
baseline, 6 months, 12 months
Body Composition
Time Frame: baseline, 6 months, 12 months
baseline, 6 months, 12 months
Venous blood
Time Frame: baseline, 6 months, 12 months
baseline, 6 months, 12 months
Work performance
Time Frame: baseline, 6 months, 12 months
baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: James A Levine, MD PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

October 28, 2011

Last Update Submitted That Met QC Criteria

October 27, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-003809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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