NCT02094170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
601

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

3.2 years

First QC Date

March 13, 2014

Last Update Submit

June 17, 2019

Conditions

Physical ActivitySedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

  • Blood Insulin Levels

    14 Days

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

700 35 - 80 year old adults living in San Diego County

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • 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.

    PMID: 30760246DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA and RNA will be collected from your blood. This may be used to look at genetic components important to your health. DNA may be analyzed for important genetic determinants that indicate unhealthy environment exposure and risk of obesity, cancer, and cardiometabolic disease. Data from such analyses could guide and may help us learn more about genetic markers of therapeutic or prevention effectiveness and risk of chronic disease associated with obesity and unhealthy environment exposure, including cancer.

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jacqueline Kerr, PhD

    UC San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 21, 2014

Study Start

July 1, 2014

Primary Completion

September 29, 2017

Study Completion

September 29, 2017

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

US(1)