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

NCT01461382 | Completed

• 1 other identifier: 07-003809
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Daily Physical Activity

  Measured for all waking hours using tri-axial accelerometry.

  1 year

Secondary Outcomes (4)

• Body Weight

  baseline, 6 months, 12 months

• Body Composition

  baseline, 6 months, 12 months

• Venous blood

  baseline, 6 months, 12 months

• Work performance

  baseline, 6 months, 12 months

Study Arms (2)

Phase I

EXPERIMENTAL

Entered Study May 2008.

Other: Treadmill Desks

Phase II

EXPERIMENTAL

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

Interventions

Treadmill Desks OTHER

Treadmill Desk were installed in subjects personal workspace.

Phase I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be recruited regardless of race/ethnicity.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James A Levine, MD PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 28, 2011
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

US (1)