Cardiovascular DiseaseNCT00542438
Home-Based Measures of Physical Activity and Body Composition
A study testing Physical Activity Recall and Environmental Assessments in people with Cardiovascular Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Physical Activity Recall and Environmental Assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2007to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- pregnant women
- children under 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Feasibility and Validity of Home-Based Measures of Physical Activity and Body Composition
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.
Read the 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:
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.
- Conditions
- Cardiovascular Disease
- Being tested
- Physical Activity Recall, Environmental Assessments
- Keywords
- Cardiovascular Disease, Cancer Prevention, Physical Activity, Body Composition, Environment, Exercise
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity RecallBehavioural
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.
Environmental AssessmentsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Recall | Active comparator | 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. Receives: Behavioral: Physical Activity Recall |
| Environmental Assessment | Active comparator | 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). Receives: Behavioral: Environmental Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of home-based data collection methods: Percentage of Participants Completing Step Test
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.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study start9 Oct 2007
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542438
- Sponsor's protocol ID
- 2007-0278
- Other IDs
- NCI-2011-02917
- Status last verified
- Aug 2026
- First submitted
- 10 Oct 2007
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Validity of Home-Based Measures of Physical Activity and Body Composition
- ClinicalTrials.gov ID
- NCT00542438
- Acronym / sponsor ID
- 2007-0278
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular Disease, Cancer Prevention, Physical Activity, Body Composition, Environment, Exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Oct 2007 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Recall | Active comparator | Behavioral: Physical Activity RecallHand-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. |
| Environmental Assessment | Active comparator | Behavioral: Environmental AssessmentsEnvironmental 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- pregnant women
- children under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity RecallHand-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. | Behavioural | Physical Activity Recall |
| Environmental AssessmentsHand-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). | Behavioural | Environmental Assessment |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Basen-Engquist, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Recall and Environmental Assessments in people with Cardiovascular Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of home-based data collection methods: Percentage of Participants Completing Step Test (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.