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Global Positioning System (GPS) Exposure to Environments & Relations With Biomarkers of Cancer Risk

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT02094170
Collaborator
(none)
601
Enrollment
1
Location
39
Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    601 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Global Positioning System (GPS) Exposure to Environments & Relations With Biomarkers of Cancer Risk
    Study Start Date :
    Jul 1, 2014
    Actual Primary Completion Date :
    Sep 29, 2017
    Actual Study Completion Date :
    Sep 29, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Blood Insulin Levels [14 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    • 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.

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC San Diego La Jolla California United States 92093

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

    • Principal Investigator: Jacqueline Kerr, PhD, UC San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marta Jankowska, Principal Investigator, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT02094170
    Other Study ID Numbers:
    • 1R01CA179977
    First Posted:
    Mar 21, 2014
    Last Update Posted:
    Jun 19, 2019
    Last Verified:
    Jun 1, 2019

    Study Results

    No Results Posted as of Jun 19, 2019