Physical ActivityNCT02094170
Global Positioning System (GPS) Exposure to Environments & Relations With Biomarkers of Cancer Risk
An observational study of Physical Activity and Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
Trial summary
The prevalence of overweight and obesity are increasing worldwide. In the U.S., approximately 85,000 new cancer cases per year are related to obesity. Understanding lifestyle behaviors, their causes, and relations to cancer are critical. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Lifestyle
- How many people
- 601 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 29 Sep 2017
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 700 35 - 80 year old adults living in San Diego County
Who may be able to join
- 35 - 80 years
- live in the same residence selected for the study for at least one year
- are able to walk without human assistance
- are able to read and write fluently in English or Spanish
- have a stable phone
- leave their home at least 3 or more times per week
Show all 11Show fewer
- have a stable weight over the past 3 months (+/- 5 lbs)
- spend most of their time within San Diego County
- will be in San Diego County for the study period (i.e. not travel or border crossing)
- are able to give informed consent and comply with the protocol
- are willing to complete all assessments and wear all devices for 14 days.
Who cannot join
- are younger than 435 or older than 80 years of age
- are pregnant or nursing
- have a mental state that would preclude complete understanding of the protocol or compliance
- have a chronic illness that may be associated with weight change
- are participating in another clinical trial
- have type 1 diabetes
Show all 15Show fewer
- have an autoimmune disorder such as lupus, rheumatoid arthritis, or multiple sclerosis
- have an intestinal disease such as celiac disease, Crohn's disease, or inflammatory bowel disease (IBD) or sensitivities or allergies to gluten
- have psoriasis
- have a history of or a current eating disorder
- have had previous weight loss surgery
- plan to travel into Mexico during the two-week study period or have a history of travel to Mexico
- are taking second generation or "atypical" antipsychotics
- live with someone else who is participating in this study
- are currently taking weight loss supplements and unwilling to stop for a predetermined "wash-out" period
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of overweight and obesity are increasing worldwide. In the U.S., approximately 85,000 new cancer cases per year are related to obesity. Understanding lifestyle behaviors, their causes, and relations to cancer are critical. Where people spend their time during the day may be related to their risk of getting cancer. This project will assess behaviors in different locations across the day and relate exposure to different environments to biological outcomes.
Read the detailed description
The purpose of this study is to advance methods of cancer risk exposure assessment by measuring both neighborhood access and total environment exposure to healthy environments by dynamically integrating Global Positioning System (GPS) data with Geographical Information System (GIS) data. We hypothesize that dynamic GPS based measures of environmental exposure will be more strongly related to behavior and insulin and inflammation biomarkers than static address based GIS measures of access.
Primary Aim:
To compare Dynamic vs Static GIS measures of physical activity (PA) supportivity and their associations with PA behaviors, body mass index (BMI), and biological markers.
Secondary Aim:
To compare Dynamic vs Static GIS measures of access to healthy food and their associations with dietary intake, BMI, and biological markers.
Exploratory aim:
Social environment (e.g. eating with others) has been identified as an important determinant of health, but assessment of this has been limited to self-report through surveys or text prompts. Images from a person worn camera (the SenseCam) provide an objective and continuous assessment of social environment e.g. number of social interactions per day, eating alone or with others. In a subsample of participants (N=30), we propose to explore whether portable SenseCam measures of social interactions \& social behaviors from person view images are more strongly related to breast and colon cancer risk factors than self-reported social environment measures. Behaviors and built environments (especially food locations) can also be coded to validate the accuracy of the GIS measures and the machine learned behavior categories employed in the full sample.
- Conditions
- Physical Activity, Sedentary Lifestyle
- Medical subject headings
- Motor Activity, Sedentary Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Insulin Levels
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJul 2014
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
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.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 601 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
- Investigators
- Jacqueline Kerr, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094170
- Sponsor's protocol ID
- 1R01CA179977
- Status last verified
- Jun 2019
- First submitted
- 13 Mar 2014
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Jankowska MM, Sears DD, Natarajan L, Martinez E, Anderson CAM, Sallis JF, Matthews SA, Crist K, Dillon L, Johnson E, Barrera-Ng A, Full K, Godbole S, Kerr J. Protocol for a cross sectional study of cancer risk, environmental exposures and lifestyle behaviors in a diverse community sample: the Community of Mine study. BMC Public Health. 2019 Feb 13;19(1):186. doi: 10.1186/s12889-019-6501-2.
PubMed 30760246
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Positioning System (GPS) Exposure to Environments & Relations With Biomarkers of Cancer Risk
- ClinicalTrials.gov ID
- NCT02094170
- Acronym / sponsor ID
- 1R01CA179977
- Conditions
- Physical Activity, Sedentary Lifestyle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 21 Mar 2014 (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 prevalence of overweight and obesity are increasing worldwide. In the U.S., approximately 85,000 new cancer cases per year are related to obesity. Understanding lifestyle behaviors, their causes, and relations to cancer are critical. Where people spend their time during the day may be related to their risk of getting cancer. This project will assess behaviors in different locations across the day and relate exposure to different environments to biological outcomes.
Detailed description
The purpose of this study is to advance methods of cancer risk exposure assessment by measuring both neighborhood access and total environment exposure to healthy environments by dynamically integrating Global Positioning System (GPS) data with Geographical Information System (GIS) data. We hypothesize that dynamic GPS based measures of environmental exposure will be more strongly related to behavior and insulin and inflammation biomarkers than static address based GIS measures of access.
Primary Aim:
To compare Dynamic vs Static GIS measures of physical activity (PA) supportivity and their associations with PA behaviors, body mass index (BMI), and biological markers.
Secondary Aim:
To compare Dynamic vs Static GIS measures of access to healthy food and their associations with dietary intake, BMI, and biological markers.
Exploratory aim:
Social environment (e.g. eating with others) has been identified as an important determinant of health, but assessment of this has been limited to self-report through surveys or text prompts. Images from a person worn camera (the SenseCam) provide an objective and continuous assessment of social environment e.g. number of social interactions per day, eating alone or with others. In a subsample of participants (N=30), we propose to explore whether portable SenseCam measures of social interactions \& social behaviors from person view images are more strongly related to breast and colon cancer risk factors than self-reported social environment measures. Behaviors and built environments (especially food locations) can also be coded to validate the accuracy of the GIS measures and the machine learned behavior categories employed in the full sample.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 700 35 - 80 year old adults living in San Diego County
Key inclusion criteria (11 listed)
- 35 - 80 years
- live in the same residence selected for the study for at least one year
- are able to walk without human assistance
- are able to read and write fluently in English or Spanish
- have a stable phone
Key exclusion criteria (15 listed)
- are younger than 435 or older than 80 years of age
- are pregnant or nursing
- have a mental state that would preclude complete understanding of the protocol or compliance
- have a chronic illness that may be associated with weight change
- are participating in another clinical trial
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
Blood Insulin Levels
Time frame: 14 Days
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 19 Jun 2019.
- Derived from this study: PubMed 30760246Jankowska MM, Sears DD, Natarajan L, Martinez E, Anderson CAM, Sallis JF, Matthews SA, Crist K, Dillon L, Johnson E, Barrera-Ng A, Full K, Godbole S, Kerr J. Protocol for a cross sectional study of cancer risk, environmental exposures and lifestyle behaviors in a diverse community sample: the Community of Mine study. BMC Public Health. 2019 Feb 13;19(1):186. doi: 10.1186/s12889-019-6501-2.
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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.
Jacqueline Kerr, PhD principal investigator
UC San Diego
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 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 11 inclusion and 15 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 19 Jun 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?
Blood Insulin Levels (time frame: 14 Days). 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 NCT02094170, 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 19 Jun 2019.