Trial Information

Feasibility and Validity of Home-Based Measures of Physical Activity and Body Composition

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:

- Your height and weight will be measured.

- You will complete a questionnaire about your health, your neighborhood, and your
physical activity. The questionnaire will take about 30 minutes to complete.

- You will walk on a treadmill while your heart rate, blood pressure, and respiration
(breathing) are monitored. You will walk until you feel fatigued.

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:

- You will perform the stool-stepping test.

- You will have your waist and hip circumference measured.

- You will be asked about your physical activity over the past week.

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.