Physical ActivityNCT00342212
Actigraph Accelerometer Validation Study
An observational study of Physical Activity, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Apr 2008
- Phase
- Observational
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- None given
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Westat, Inc.
Rockville, Maryland, 20850
University of Utah
Salt Lake City, Utah, 84112
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Physical Activity
- Keywords
- Walking, Jogging, Bridging Study, Data Comparability, Healthy Adults, Healthy Volunteer, HV
- Medical subject headings
- Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startMar 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342212
- Sponsor's protocol ID
- 999906131
- Other IDs
- 06-C-N131
- Status last verified
- May 2011
- First submitted
- 19 Jun 2006
- Last updated
- 25 May 2011
- Results posted
- No
Publications
Thomas S, Reading J, Shephard RJ. Revision of the Physical Activity Readiness Questionnaire (PAR-Q). Can J Sport Sci. 1992 Dec;17(4):338-45.
PubMed 1330274
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actigraph Accelerometer Validation Study
- ClinicalTrials.gov ID
- NCT00342212
- Acronym / sponsor ID
- 999906131
- Conditions
- Physical Activity
- Keywords
- Walking, Jogging, Bridging Study, Data Comparability, Healthy Adults, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2006
- Study completion
- Apr 2008 (actual)
- First posted
- 21 Jun 2006 (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.
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 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 design
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 25 May 2011.
- Background: PubMed 1330274Thomas S, Reading J, Shephard RJ. Revision of the Physical Activity Readiness Questionnaire (PAR-Q). Can J Sport Sci. 1992 Dec;17(4):338-45.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by National Cancer Institute (NCI) at 2 sites 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?
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 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342212, which also lists 1 linked publication.
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 25 May 2011.