Physical ActivityNCT01886261
Validation of Objective Measures of Place-Based Physical Activity
An observational study of Physical Activity, run by University of California, San Diego at 1 site in United States.
Trial summary
Usability of the PALMS system, validity of the PALMS system and added value to an existing cohort study. Hypothesis: Addition of GPS device and use of PALMS system will allow researchers to better examine place-based interventions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Validation Study: We will be recruiting 40 primarily Spanish speaking, adults from various community locations throughout San Diego County. Usability Testing: Recruiting research staff member from the SDSU Fe en Accion research study to participate in usability testing. Added Value Cohort: Fe en Accion Participants of the Fe en Accion cohort.
Who may be able to join
- Adults (18+ years old)
- Self-identify as Hispanic/Latino(a)
- Have a variety of primary transportation modes
- Have a variety of physical activity levels both occupational and leisure
- Commute different distances to the location
- Attend church weekly
Show all 11Show fewer
- Age: 18 - 65 years old
- Must live in San Diego County
- Live within 4 miles of their church
- engage in less than 150 minutes of leisure time moderate and vigorous physical activity
- Latina woman
Who cannot join
- Illness that prevents normal activities
- Inability to ambulate
- Unable to wear the devices for up to 7 days
- Unable to complete two phone interviews in English or Spanish
- Unable to complete a written survey in English or Spanish
- Usability Testing:
- Research staff members of the SDSU Fe en Accion research study.
- Added Value Cohort: Fe en Accion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Usability of the PALMS system, validity of the PALMS system and added value to an existing cohort study.
Hypothesis: Addition of GPS device and use of PALMS system will allow researchers to better examine place-based interventions.
Read the detailed description
The Personal Activity Location Measurement System (PALMS) researchers at UCSD have created a web-based processing system for location (GPS) and physical activity (accelerometer) data. We will collect data on a pilot sample of 40 Hispanic persons to a) test the validity of PALMS assessments of transportation modes, and activity in different locations against an objective record of activities derived from images collected by Vicon Revue; b) compare PALMS assessments of transportation modes and activity locations to other self-report measures and interview measures; c) assess the construct validity of PALMS-based activity assessment.
We will be assessing the usability of PALMS in a research staff with no previous experience of using the PALMS system. We will be assessing the added value of using PALMS to examine a place-based intervention in an existing cohort study.
- Conditions
- Physical Activity
- Keywords
- validation, physical activity, place-based interventions, construct validity, divergent validity, usability, gps, PALMS
- Medical subject headings
- Motor Activity, Gray Platelet Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct Validity
Construct validity assesses the theoretical relationship of a measure (and resulting variables) with other variables. The multitrait-multimethod matrix (MTMM) is a procedure first developed by Campbell and Fiske to asses construct validity by creating a fully crossed method-by-measure matrix of associations among multiple constructs and multiple measurement methods. The resulting matrix of correlation coefficients gives a pattern of associations that informs the validity evidence of the measure and construct. We will use the following measures in the multitrait multimethod matrix: Neighborhood Physical Activity Questionnaire, the American Timeuse Survey, and PALMS based physical activity in location estimates.
Measured: 7 days
Usability
Direct observation of research staff with no experience using the PALMS system.
Measured: 1 day
Added Value
We will be assessing GPS tracks in participants in the Fe en Accion cohort to determine the effectiveness of the place-based intervention.
Measured: baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startSep 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kevin Patrick, MD, MS, University of California, San Diego
- Investigators
- Kevin Patrick, MD, MS, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886261
- Sponsor's protocol ID
- 111274/ 121378
- Other IDs
- R01CA167693
- Status last verified
- Dec 2014
- First submitted
- 15 Jan 2013
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Objective Measures of Place-Based Physical Activity
- ClinicalTrials.gov ID
- NCT01886261
- Acronym / sponsor ID
- 111274/ 121378
- Conditions
- Physical Activity
- Keywords
- validation, physical activity, place-based interventions, construct validity, divergent validity, usability, gps, PALMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- San Diego State University, National Cancer Institute (NCI)
- Study start
- Sep 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Jun 2013 (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.
Usability of the PALMS system, validity of the PALMS system and added value to an existing cohort study.
Hypothesis: Addition of GPS device and use of PALMS system will allow researchers to better examine place-based interventions.
Detailed description
The Personal Activity Location Measurement System (PALMS) researchers at UCSD have created a web-based processing system for location (GPS) and physical activity (accelerometer) data. We will collect data on a pilot sample of 40 Hispanic persons to a) test the validity of PALMS assessments of transportation modes, and activity in different locations against an objective record of activities derived from images collected by Vicon Revue; b) compare PALMS assessments of transportation modes and activity locations to other self-report measures and interview measures; c) assess the construct validity of PALMS-based activity assessment.
We will be assessing the usability of PALMS in a research staff with no previous experience of using the PALMS system. We will be assessing the added value of using PALMS to examine a place-based intervention in an existing cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Validation Study: We will be recruiting 40 primarily Spanish speaking, adults from various community locations throughout San Diego County. Usability Testing: Recruiting research staff member from the SDSU Fe en Accion research study to participate in usability testing. Added Value Cohort: Fe en Accion Participants of the Fe en Accion cohort.
Key inclusion criteria (11 listed)
- Adults (18+ years old)
- Self-identify as Hispanic/Latino(a)
- Have a variety of primary transportation modes
- Have a variety of physical activity levels both occupational and leisure
- Commute different distances to the location
Key exclusion criteria (8 listed)
- Illness that prevents normal activities
- Inability to ambulate
- Unable to wear the devices for up to 7 days
- Unable to complete two phone interviews in English or Spanish
- Unable to complete a written survey in English or Spanish
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
Construct Validity
Time frame: 7 days
Construct validity assesses the theoretical relationship of a measure (and resulting variables) with other variables. The multitrait-multimethod matrix (MTMM) is a procedure first developed by Campbell and Fiske to asses construct validity by creating a fully crossed method-by-measure matrix of associations among multiple constructs and multiple measurement methods. The resulting matrix of correlation coefficients gives a pattern of associations that informs the validity evidence of the measure and construct. We will use the following measures in the multitrait multimethod matrix: Neighborhood Physical Activity Questionnaire, the American Timeuse Survey, and PALMS based physical activity in location estimates.
Usability
Time frame: 1 day
Direct observation of research staff with no experience using the PALMS system.
Added Value
Time frame: baseline and 1 year
We will be assessing GPS tracks in participants in the Fe en Accion cohort to determine the effectiveness of the place-based intervention.
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 5 Dec 2014.
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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.
Kevin Patrick, MD, MS principal investigator
UCSD
1 site 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 University of California, San Diego 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 11 inclusion and 8 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 5 Dec 2014. 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?
Construct Validity (time frame: 7 days). The study lists 3 primary outcomes in all. 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 5 Dec 2014.