Feasibility and Validity of Home-Based Measures of Physical Activity and Body Composition
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Feasibility of home-based data collection methods: Percentage of Participants Completing Step Test
Study Overview
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.
Detailed Description
SCREENING PHONE CALL:
If you are interested in taking part in this study, the study staff will contact you by phone and you will answer questions about your physical ability to exercise. Based on the answers you give, the study doctor will decide if you are eligible to participate. The phone call will last about 10-15 minutes.
STUDY PROCEDURES:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to complete physical activity recall and environmental assessments on a palm pilot either 3 times a day or once a day. For the physical activity recall assessment, you will describe what types of physical activity you did that day. The environmental assessments will be to describe your current location or environment. It should take less than 5 minutes to complete each assessment.
Visit 1:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
- •speaks English
- •able to give informed consent
- •no previous cancer diagnosis
Exclusion Criteria
- •pregnant women
- •children under 18
Arms & Interventions
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.
Intervention: Physical Activity Recall (Behavioral)
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).
Intervention: Environmental Assessments (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported