Home-Based Measures of Physical Activity and Body Composition

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00542438
First received: October 10, 2007
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 Intervention
Cardiovascular Disease
Behavioral: Physical Activity Recall
Behavioral: Environmental Assessments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility and Validity of Home-Based Measures of Physical Activity and Body Composition

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility and validity of home-based data collection methods [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: October 2007
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542438

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00542438     History of Changes
Other Study ID Numbers: 2007-0278
Study First Received: October 10, 2007
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014