ObesityNCT01461382
Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss
A study testing Treadmill Desks in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Treadmill Desks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2009
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be recruited regardless of race/ethnicity.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Treadmill Desks
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill DesksOther
Treadmill Desk were installed in subjects personal workspace.
Treadmill DesksOther
Treadmill desks were installed in subjects personal workspace six months after phase I started.
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Entered Study May 2008. Receives: 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. Receives: Other: Treadmill Desks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Physical Activity
Measured for all waking hours using tri-axial accelerometry.
Measured: 1 year
Secondary outcomes (4)
Body Weight
Measured: baseline, 6 months, 12 months
Body Composition
Measured: baseline, 6 months, 12 months
Venous blood
Measured: baseline, 6 months, 12 months
Work performance
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionDec 2009
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Levine, Mayo Clinic
- Investigators
- James A Levine, MD PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461382
- Sponsor's protocol ID
- 07-003809
- Status last verified
- Oct 2011
- First submitted
- 24 Oct 2011
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss
- ClinicalTrials.gov ID
- NCT01461382
- Acronym / sponsor ID
- 07-003809
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Oct 2011 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Other: Treadmill DesksEntered Study May 2008. |
| Phase II | Experimental | Other: Treadmill DesksPhase 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will be recruited regardless of race/ethnicity.
Key exclusion criteria (12 listed)
- Definite termination criteria.
- 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.
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 |
|---|---|---|
| Treadmill DesksTreadmill Desk were installed in subjects personal workspace. | Other | Phase I |
| Treadmill DesksTreadmill desks were installed in subjects personal workspace six months after phase I started. | Other | Phase II |
Primary outcome
Daily Physical Activity
Time frame: 1 year
Measured for all waking hours using tri-axial accelerometry.
4 secondary outcomes
Body Weight
Time frame: baseline, 6 months, 12 months
Body Composition
Time frame: baseline, 6 months, 12 months
Venous blood
Time frame: baseline, 6 months, 12 months
Work performance
Time frame: baseline, 6 months, 12 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 28 Oct 2011.
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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.
James A Levine, MD PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Desks in people with Obesity, run by Mayo Clinic 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 1 inclusion and 12 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 28 Oct 2011. 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. 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?
Daily Physical Activity (time frame: 1 year). 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 28 Oct 2011.