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

NCT ID: NCT01461382

Last Updated: 2011-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Phase I

Entered Study May 2008.

Group Type: EXPERIMENTAL

Treadmill Desks

Intervention Type: OTHER

Treadmill Desk were installed in subjects personal workspace.

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.

Group Type: EXPERIMENTAL

Treadmill Desks

Intervention Type: OTHER

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

Interventions

Treadmill Desks

Treadmill Desk were installed in subjects personal workspace.

Intervention Type: OTHER

Treadmill Desks

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

James Levine

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James A Levine, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

07-003809

Identifier Type: -

Identifier Source: org_study_id