Clinical trial NCT01461382: Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss
Official title: Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Daily Physical Activity
timeFrame: 1 year
Secondary outcomes:
measure: Body Weight
timeFrame: baseline, 6 months, 12 months
measure: Body Composition
timeFrame: baseline, 6 months, 12 months
measure: Venous blood
timeFrame: baseline, 6 months, 12 months
measure: Work performance
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James A Levine, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: