We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Home-Based Measures of Physical Activity and Body Composition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00542438
Recruitment Status : Active, not recruiting
First Posted : October 11, 2007
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The specific aim of this study is to collect preliminary data on the feasibility and validity of home-based data collection methods to measure four constructs:

  • Physical Activity: Real-time assessment using Ecological Momentary Assessment (EMA) and pedometers
  • Cardiorespiratory Fitness: Step test
  • Anthropometry: Waist and hip circumference measurements
  • Environmental Variables: Examples include density of neighborhood physical activity facilities (including gyms, parks, walking trails), crime, land use mix, and transportation variables, collected by participants using EMA.

Condition or disease Intervention/treatment
Cardiovascular Disease Behavioral: Physical Activity Recall Behavioral: Environmental Assessments

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility and Validity of Home-Based Measures of Physical Activity and Body Composition
Actual Study Start Date : October 2007
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Physical Activity Recall
Hand-held computers will be used to record information for 7 days about physical activity. Assessments will be completed either 3 times a day or once a day.
Behavioral: Physical Activity Recall
Hand-held computers will be used to record information for 7 days about physical activity. Assessments will be completed either 3 times a day or once a day.
Active Comparator: Environmental Assessment
Environmental assessments on a palm pilot either 3 times a day or once a day. Hand-held computer programs will be used to collect information about the community. Some factors will be assessed only once (e.g., availability of facilities) while other information will be collected over the course of 7 days (e.g., perceptions of neighborhood safety).
Behavioral: Environmental Assessments
Hand-held computer programs will be used to collect information about the community. Some factors will be assessed only once (e.g., availability of facilities) while other information will be collected over the course of 7 days (e.g., perceptions of neighborhood safety).


Outcome Measures

Primary Outcome Measures :
  1. Feasibility of home-based data collection methods: Percentage of Participants Completing Step Test [ Time Frame: 3 Years ]
    Feasibility measured by the percentage of participants who have adequate cardiorespiratory fitness (i.e., V02 max greater than or equal to 31) to perform the step test. Researchers will consider the test feasible if greater than or equal to 75% of the participants have adequate fitness to perform the test.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. low-risk for cardiovascular disease, as defined by the American College of Sports Medicine (under 45 years of age for men and under 55 years of age for women, and less than two cardiovascular risk factors)
  2. speaks English
  3. able to give informed consent
  4. no previous cancer diagnosis

Exclusion Criteria:

  1. pregnant women
  2. children under 18
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542438


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00542438     History of Changes
Other Study ID Numbers: 2007-0278
NCI-2011-02917 ( Registry Identifier: NCI CTRP )
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Cardiovascular Disease
Cancer Prevention
Physical Activity
Body Composition
Environment
Exercise

Additional relevant MeSH terms:
Cardiovascular Diseases