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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01886261
Other study ID # 111274/ 121378
Secondary ID R01CA167693
Status Completed
Phase N/A
First received January 15, 2013
Last updated December 3, 2014
Start date September 2011
Est. completion date May 2014

Study information

Verified date December 2014
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Validation Study

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Inclusion Criteria (Participants of the cohort):

- Attend church weekly

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of California, San Diego La Jolla California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Diego National Cancer Institute (NCI), San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 7 days No
Primary Usability Direct observation of research staff with no experience using the PALMS system. 1 day No
Primary 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. baseline and 1 year No
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