Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00542438 |
| Other study ID # |
2007-0278 |
| Secondary ID |
NCI-2011-02917 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 9, 2007 |
| Est. completion date |
May 31, 2026 |
Study information
| Verified date |
June 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
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.
