- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01587092
Workstation Pilot Study
WorkStation Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eligible participants will be randomized by chance to the WorkStation Intervention Group or to a Usual Working Condition Group.
The WorkStation Intervention Group will be asked to walk for up to 1.5 hours per day during the work week of Monday through Friday on the treadmill. Participants will complete two sessions per day for up to 45 minutes per session, tracking time and speed.
Usual Working Condition Group will be asked to continue working in usual environment and accustomed manner.
Regardless of which group the participants are assigned to, the participants will be asked to complete baseline and follow up assessment visits. Months 3 and 6 for approximately 1 hour for Body measurements (height, weight and waist circumference), body fat percent, gait speed, questionnaires, and accelerometry.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females
- BMI ≥ 25 kg/m2
- Willing to give informed consent
- Willing to accept randomization to group assignment and willing to follow the protocol for the group to which they have been assigned
- Willing to maintain fulltime employment at the company for the next 6 months
- Willing to receive frequent contacts and communication from study staff over the next 6 months
Exclusion Criteria:
- Current participation in other Pennington Biomedical research studies
- BMI < 25 kg/m2
- Type 1 diabetes
- Average step count of ≥ 7,500 steps/day
- Self-reporting exercising > 20 minutes on 3 or more days/wk, within the past 6 months
- Unable to walk 45 minutes continuously without taking a rest
- Unable to walk without the use of an assistive device, such as a cane or walker
- Have had a cardiovascular event (stroke or heart attack) in the past 6 months
- Have a pacemaker or any other internal electrical medical device
- Have been diagnosed with Schizophrenia or bipolar disorder
- Have any condition that would limit participation in a physical activity program
- Women who are pregnant, have been pregnant in the last 6 months, or are breastfeeding
- Actively participating in a weight loss program
- Plan to move out of the study area within the next 6 months or plan to be away from work for more than 4 weeks in the next 6 months
- Have another member of household participating in the study
- Have any condition, which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Usual Working Condition Group
Participants assigned to the usual working condition control group will continue to work in their usual environment and accustomed manner.
The control group participants will have access to the Workstations at the completion of study.
|
Participants will be asked to continue working at their desk in their usual manner.
|
|
Active Comparator: WorkStation Intervention Group
Participants will be asked to walk for up to 1.5 hours per day on the treadmill.
This will be split into two 45 minute sessions per day.
Behavioral support will focus on adherence to frequency (attending scheduled sessions).
Participants self-select speed of walking and time (they have up to 45 minutes allotted, but may choose less as they like).
|
Participants will be asked to attend 2 scheduled sessions per day of treadmill walking, which will replace their sitting desk time.
Participants will complete 2 sessions per day for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist
Time Frame: 6 months
|
Waist circumference will decrease in workers assigned to the WorkStation working condition relative to the usual working condition.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Assessments
Time Frame: 6 months
|
Weight will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
|
Body Fat Percent
Time Frame: 6 months
|
Body fat percent will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
|
Accelerometry
Time Frame: 6 months
|
Participants' activity level measured by the accelerometer will increase in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
|
Gait Speed
Time Frame: 6 months
|
Participants' gait speed will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
|
Stress
Time Frame: 6 months
|
Participants' stress level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
|
Fatigue
Time Frame: 6 months
|
Participants' fatigue level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
|
Quality of life Questionnaire
Time Frame: 6 months
|
Participants' quality of life will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catrine Tudor-Locke, PhD, Principal Investigator
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 12015
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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