University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT00542438
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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:
You will come to the M. D. Anderson Behavioral Research and Treatment Center for 2 visits. At the first visit, the following tests and procedures will be performed:
The research staff will then give you instructions for the tests you will do at home. This visit will last about 120 minutes.
At Home Activities:
During the next week, you will wear a pedometer and an actigraph. These are small devices that you wear on your waist during the day from the time you get up in the morning to when you go to bed at night. You will not wear the devices in water. These devices will record how active you are.
You will answer questions on a handheld computer 5-7 times each day. These questions will ask about your physical activity and about how your environment may encourage or discourage physical activity. It will take between 30 seconds and 3 minutes to answer the questions each time.
You will measure the distance around your waist and hips (circumference). You will do a fitness test that involves stepping up and down on a small stool for 3 minutes. You will take your heart rate after the stool-stepping exercise. The study staff will give you all the equipment and supplies needed for these tests at the first visit, and you will be asked to return the equipment at the second visit.
Visit 2:
Seven (7) days after the first visit, you will return to M. D. Anderson for the second visit. The following tests and procedures will be performed:
This visit will take about 60 minutes.
LENGTH OF STUDY:
You will be off-study once you complete Visit 2.
This is an investigational study. Up to 75 individuals will take part in the study. All will be enrolled at M. D. Anderson.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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.
M.D. Anderson Cancer Center
Other
Feasibility and Validity of Home-Based Measures of Physical Activity and Body Composition
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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