Physical ActivityiWatchNCT01775826
Validating Machine -Learned Classifiers of Sedentary Behavior and Physical Activity
A study testing Measurement in people with Physical Activity and Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
Trial summary
The majority of the US population spends most of the day sitting and the we have new scientific evidence that this can contribute to poor health regardless of how much physical activity a person does. Read more about this study
- Who is it for?
- Ages 6 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Lifestyle
- What is being tested?
- Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Apr 2016
- 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 6 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- provide written parental consent to complete study protocols;
- provide verbal assent to complete study protocols;
- willingness to complete 2 visits to UCSD offices;
- willingness to wear multiple sensor devices on 7 days for 12 hours per day;
- willingness to wear wrist accelerometer on 7 days for 24 hours per day;
- willingness to have their height and weight measured;
Show all 25Show fewer
- be able to walk unassisted
- able to read and understand study materials in English.
- provide written consent to complete study protocols;
- willingness to complete 2 visits to UCSD offices;
- willingness to wear multiple sensor devices on 7 days for 12 hours per day;
- willingness to wear wrist accelerometer on 7 days for 24 hours per day;
- complete a survey assessing their demographic characteristics;
- willingness to have their height and weight measured;
- be physically and cognitively able to walk unassisted,
- able to read and understand study materials in English.
- provide written consent to complete study protocols;
- correctly answer verbal questions about their comprehension of the informed consent;
- willingness to complete 2 visits to UCSD offices;
- willingness to wear multiple sensor devices on 7 days for 12 hours per day;
- willingness to wear wrist accelerometer on 7 days for 24 hours per day;
- complete a survey assessing their demographic;
- willingness to have their height and weight measured;
- be physically and cognitively able to walk without the assistance of another person (walking aids are permitted)
- able to read and understand study materials in English.
Who cannot join
- unable to ambulate;
- attends a workplace or school on monitoring days that prohibits static images being taken by a SenseCam worn around the neck of the participant;
- pregnancy in second or third trimester.
Trial locations and contacts
1 site in 1 country.
About this study
The majority of the US population spends most of the day sitting and the we have new scientific evidence that this can contribute to poor health regardless of how much physical activity a person does. However, we do not measure sitting time very accurately and when we ask people to tell us how much they do, their answers are unreliable. Our study will use small sensors to objectively measure when people sit or do physical activity, and we will use sophisticated computational techniques to summarize these movement patterns.
- Conditions
- Physical Activity, Sedentary Lifestyle
- Being tested
- Measurement
- Keywords
- physical activity, sedentary behavior, accelerometer, GPS, GIS, machine learning
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementOther
Measured usual (day-to-day) behavior with body-worn sensors.
| Study group | Role | What they receive |
|---|---|---|
| All Purposes | Other | All participants. Receives: Other: Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity behavior classification using study sensors (accelerometers, Sensecam and GPS)
Using an annotated data set of SenseCam images in three free-living population subgroups, we will compare sensitivity, specificity and percent agreement between behavioral classifiers derived from: (a) single axis vs. multi axis accelerometers; (b) aggregated movement counts vs. raw acceleration data; (c) hip vs. wrist mounted accelerometers.
Determine (a) the extent to which adding GPS data improves discrimination accuracy over accelerometer only behavior classification (i.e., best classifier resulting from Aim 1); and (b) the extent to which adding GIS data improves discrimination accuracy over accelerometer and GPS behavior classification alone (i.e., best classifier resulting from Aim 2a).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Jankowska, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775826
- Sponsor's protocol ID
- 1R01CA164993-01A1
- Acronym
- iWatch
- Status last verified
- Aug 2019
- First submitted
- 17 Jan 2013
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Moghimi, Mohammad**; Kerr, Jacqueline; Johnson, Eileen; Godbole, Suneeta; Belongie, Serge Discriminative Regions: A Substrate for Analyzing Life-Logging Image Sequences MultiMedia Modeling 2015 357-368.
Kerr J, Patterson RE, Ellis K, Godbole S, Johnson E, Lanckriet G, Staudenmayer J. Objective Assessment of Physical Activity: Classifiers for Public Health. Med Sci Sports Exerc. 2016 May;48(5):951-7. doi: 10.1249/MSS.0000000000000841.
PubMed 27089222Ellis K, Kerr J, Godbole S, Staudenmayer J, Lanckriet G. Hip and Wrist Accelerometer Algorithms for Free-Living Behavior Classification. Med Sci Sports Exerc. 2016 May;48(5):933-40. doi: 10.1249/MSS.0000000000000840.
PubMed 26673126
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Machine -Learned Classifiers of Sedentary Behavior and Physical Activity
- ClinicalTrials.gov ID
- NCT01775826
- Acronym / sponsor ID
- iWatch / 1R01CA164993-01A1
- Conditions
- Physical Activity, Sedentary Lifestyle
- Keywords
- physical activity, sedentary behavior, accelerometer, GPS, GIS, machine learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Jan 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.
The majority of the US population spends most of the day sitting and the we have new scientific evidence that this can contribute to poor health regardless of how much physical activity a person does. However, we do not measure sitting time very accurately and when we ask people to tell us how much they do, their answers are unreliable. Our study will use small sensors to objectively measure when people sit or do physical activity, and we will use sophisticated computational techniques to summarize these movement patterns.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Purposes | Other | Other: MeasurementAll participants. |
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- provide written parental consent to complete study protocols;
- provide verbal assent to complete study protocols;
- willingness to complete 2 visits to UCSD offices;
- willingness to wear multiple sensor devices on 7 days for 12 hours per day;
- willingness to wear wrist accelerometer on 7 days for 24 hours per day;
Key exclusion criteria (3 listed)
- unable to ambulate;
- attends a workplace or school on monitoring days that prohibits static images being taken by a SenseCam worn around the neck of the participant;
- pregnancy in second or third trimester.
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 |
|---|---|---|
| MeasurementMeasured usual (day-to-day) behavior with body-worn sensors. | Other | All Purposes |
Primary outcome
physical activity behavior classification using study sensors (accelerometers, Sensecam and GPS)
Time frame: Baseline
Using an annotated data set of SenseCam images in three free-living population subgroups, we will compare sensitivity, specificity and percent agreement between behavioral classifiers derived from: (a) single axis vs. multi axis accelerometers; (b) aggregated movement counts vs. raw acceleration data; (c) hip vs. wrist mounted accelerometers. Determine (a) the extent to which adding GPS data improves discrimination accuracy over accelerometer only behavior classification (i.e., best classifier resulting from Aim 1); and (b) the extent to which adding GIS data improves discrimination accuracy over accelerometer and GPS behavior classification alone (i.e., best classifier resulting from Aim 2a).
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 20 Aug 2019.
- BackgroundMoghimi, Mohammad**; Kerr, Jacqueline; Johnson, Eileen; Godbole, Suneeta; Belongie, Serge Discriminative Regions: A Substrate for Analyzing Life-Logging Image Sequences MultiMedia Modeling 2015 357-368.
- Background: PubMed 27089222Kerr J, Patterson RE, Ellis K, Godbole S, Johnson E, Lanckriet G, Staudenmayer J. Objective Assessment of Physical Activity: Classifiers for Public Health. Med Sci Sports Exerc. 2016 May;48(5):951-7. doi: 10.1249/MSS.0000000000000841.
- Background: PubMed 26673126Ellis K, Kerr J, Godbole S, Staudenmayer J, Lanckriet G. Hip and Wrist Accelerometer Algorithms for Free-Living Behavior Classification. Med Sci Sports Exerc. 2016 May;48(5):933-40. doi: 10.1249/MSS.0000000000000840.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement in people with Physical Activity and Sedentary Lifestyle, 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 25 inclusion and 3 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 20 Aug 2019. 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?
physical activity behavior classification using study sensors (accelerometers, Sensecam and GPS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01775826, which also lists 3 linked publications.
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 20 Aug 2019.