ObesityNCT01587092
Workstation Pilot Study
A study testing WorkStation and Usual Working Condition in people with Obesity and Sedentary Lifestyle, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This is a pilot study to assess the feasibility of using treadmill desks (Workstations) within a Louisiana office workplace and to determine the effects of walking while working in overweight or obese, sedentary individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sedentary Lifestyle
- What is being tested?
- WorkStation and Usual Working Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: WorkStation Pilot Study
This is a pilot study to assess the feasibility of using treadmill desks (Workstations) within a Louisiana office workplace and to determine the effects of walking while working in overweight or obese, sedentary individuals.
Read the 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.
- Conditions
- Obesity, Sedentary Lifestyle
- Being tested
- WorkStation, Usual Working Condition
- Keywords
- walking, physical activity, sedentary behavior, workplace
- Medical subject headings
- Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkStationBehavioural
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.
Usual Working ConditionBehavioural
Participants will be asked to continue working at their desk in their usual manner.
| Study group | Role | What they receive |
|---|---|---|
| Usual Working Condition Group | Placebo comparator | 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. Receives: Behavioral: Usual Working Condition |
| WorkStation Intervention Group | Active comparator | 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). Receives: Behavioral: WorkStation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist
Waist circumference will decrease in workers assigned to the WorkStation working condition relative to the usual working condition.
Measured: 6 months
Secondary outcomes (7)
Weight Assessments
Weight will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
Measured: 6 months
Body Fat Percent
Body fat percent will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
Measured: 6 months
Accelerometry
Participants' activity level measured by the accelerometer will increase in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
Measured: 6 months
Gait Speed
Participants' gait speed will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
Measured: 6 months
Stress
Participants' stress level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
Measured: 6 months
Fatigue
Participants' fatigue level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
Measured: 6 months
Quality of life Questionnaire
Participants' quality of life will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catrine Tudor-Locke, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587092
- Sponsor's protocol ID
- PBRC 12015
- Status last verified
- Sep 2022
- First submitted
- 25 Apr 2012
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WorkStation Pilot Study
- ClinicalTrials.gov ID
- NCT01587092
- Acronym / sponsor ID
- PBRC 12015
- Conditions
- Obesity, Sedentary Lifestyle
- Keywords
- walking, physical activity, sedentary behavior, workplace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the feasibility of using treadmill desks (Workstations) within a Louisiana office workplace and to determine the effects of walking while working in overweight or obese, sedentary individuals.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Working Condition Group | Placebo comparator | Behavioral: Usual Working ConditionParticipants 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. |
| WorkStation Intervention Group | Active comparator | Behavioral: WorkStationParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WorkStationParticipants 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. | Behavioural | WorkStation Intervention Group |
| Usual Working ConditionParticipants will be asked to continue working at their desk in their usual manner. | Behavioural | Usual Working Condition Group |
Primary outcome
Waist
Time frame: 6 months
Waist circumference will decrease in workers assigned to the WorkStation working condition relative to the usual working condition.
7 secondary outcomes
Weight Assessments
Time frame: 6 months
Body Fat Percent
Time frame: 6 months
Accelerometry
Time frame: 6 months
Gait Speed
Time frame: 6 months
Stress
Time frame: 6 months
Fatigue
Time frame: 6 months
Quality of life Questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catrine Tudor-Locke, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WorkStation and Usual Working Condition in people with Obesity and Sedentary Lifestyle, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.