Viewing Study NCT00342212



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00342212
Status: COMPLETED
Last Update Posted: 2011-05-25
First Post: 2006-06-19

Brief Title: Actigraph Accelerometer Validation Study
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Actigraph Accelerometer Validation Study
Status: COMPLETED
Status Verified Date: 2011-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
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 agegender 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 walkjog 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
06-C-N131 None None None