- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00342212
Actigraph Accelerometer Validation Study
May 24, 2011 updated by: National Cancer Institute (NCI)
Background:
- Good measures of physical activity are needed for studies correlating physical activity and the risk of developing certain diseases.
- In preparation for use in a study of diseases and risk factors in Hispanic populations, NCI is evaluating a new model accelerometer to measure physical activity. An accelerometer is a small device worn on a belt at the waist that measures and records movement, capturing movement intensity and duration and associating it with clock-time.
- The new accelerometer (ActiGraph GTIM) uses a different type of motion detector from that used in the previous model (ActiGraph 7164).
Objective: To evaluate and compare the ActiGraph GTIM with the ActiGraph 7164 by collecting physical activity data using both models.
Eligibility: Men and women 18-74 years of age.
Design: Study participants wear both model accelerometers while they walk or jog around a track at several self-selected paces. Data from the two devices are compared.
Study Overview
Status
Completed
Conditions
Detailed Description
The NCI is collaborating with other NIH Institutes on a proposed extramurally funded longitudinal study of Hispanic subpopulations in the United States referred to as the Hispanic Community Health Study (HCHS).
Hispanic populations are understudied with respect to many diseases and risk factors.
To better understand the relationship between physical activity and chronic disease, and to make specific activity prescriptions, better methods are needed to improve the validity and reliability of physical activity assessment instruments to assess the frequency, duration, and intensity of physical activity.
In preparation for use in the HCHS, NCI plans to evaluate a new type of accelerometer, a small device worn on a belt at the waist that measures and records movement, capturing movement intensity and duration and associating it with clock-time.
This new accelerometer will be used in the HCHS to allow examination of levels as well as patterns of activity.
Physical activity was measured with accelerometers in the nationally representative 2003-2006 National Health and Nutrition Examination Survey (NHANES).
Between the time of the NHANES and the HCHS, there has been a change in the technology of the accelerometer used in NHANES.
To allow comparison of the physical activity data that will be collected in the HCHS to the data collected with the previous technology used in NHANES, a cross-validation study is needed.
The proposed study, the ActiGraph Accelerometer Validation Study, will compare the ActiGraph model 7164 used in NHANES with the new model GT1M to be used in the HCHS by simultaneously collecting physical activity data using both ActiGraphs under different circumstances of walking or jogging.
The study will recruit 120 men and women ages 18-74, corresponding to the age range of the HCHS.
Normal weight, overweight and obese participants will be included in each age/gender cell.
Because the devices measure movement, it is not essential that the study participants be from any particular ethnic group.
To derive comparable data for the 2 devices, the 2 accelerometer models will be worn on a belt, with one positioned on each hip.
Study participants will be asked to walk/jog around a track for a known distance at several self-selected paces.
Minute-by-minute and summary data from the two devices will be evaluated for comparability.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Rockville, Maryland, United States, 20850
- Westat, Inc.
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
- None given
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
June 19, 2006
First Submitted That Met QC Criteria
June 19, 2006
First Posted (Estimate)
June 21, 2006
Study Record Updates
Last Update Posted (Estimate)
May 25, 2011
Last Update Submitted That Met QC Criteria
May 24, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 999906131
- 06-C-N131
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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