CancerNCT01195337
Social Contextual Influences on Physical Activity
An observational study of Cancer and Prevention Harmful Effects, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to learn why some black and Latino men and women choose not to exercise very often. Researchers also want to learn more about any social and environmental factors that may affect the way an exercise program is followed. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Prevention Harmful Effects
- What is being tested?
- PA Prescription Plan, Pedometer and Newsletters
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2010to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 300 black or Latino participants in the greater Houston, Texas area.
Who may be able to join
- Black or Latino (self-defined by participant) ages 25-60 years
- Currently sedentary, defined as self-reported physical activity of </=90 minutes per week over the past 6 months
- Ready and physically able to start being physically active. Determined by asking participant if they intend to start being physically active within the next 30 days.
- Have a home address where information can be mailed
- Able to read English at a 6th grade level as assessed by the REALM
- If uncontrolled hypertension or other physical limitations that might be aggravated by participation in lifestyle moderate-intensity physical activity as determined by PA Readiness Questionnaire (PAR-Q). Participants with BP readings >/=140/90mm Hg, will have to provide a doctors note or medical clearance.
- Live within Harris County
Who cannot join
- Pregnant or thinking about becoming pregnant during the study period
- Another person in the same household is enrolled in the study
- Physical limitation that prevents engaging in PA
- MD Anderson employees who work in the Division of Cancer Prevention and Population Sciences
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: Social, Contextual, and Environmental Determinants of Physical Activity in Sedentary Minority Adults
The goal of this study is to learn why some black and Latino men and women choose not to exercise very often. Researchers also want to learn more about any social and environmental factors that may affect the way an exercise program is followed.
Read the detailed description
If you chose to take part in this study, you will receive an exercise program, a pedometer, access to a social networking site, and newsletters to help you start becoming more physically active. A pedometer is a small device worn on the hip that counts the number of steps you have taken each day.
Study Visits:
You will come in for study visits 6 times while you are on study; 1 time at the beginning of the study called "screening", 1 time for an orientation visit 7 days after the screening visit, and for follow-up visits at 8, 26, 39, and 52 weeks after you begin the exercise program.
Baseline Tests:
If you are found to be eligible to take part on this study based on the results of the screening tests, the following tests and procedures will be performed:
- You will be asked to complete a computer-based survey. The questionnaires will ask questions about stress, your motivation for physical activity, any social support you may receive from others, the neighborhood you live in, and other physical activity-related topics. The questionnaires should take about 2 hours total to complete.
- Your blood pressure will be measured.
- Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
- You will complete a fitness test. To complete the fitness test, you will either walk a circular path at the clinic for 6 minutes or complete a step test. The study staff will decide which test you will complete and will discuss the test with you in more detail. A study staff member will monitor you during this test.
Study Devices:
At the baseline visit, you will be given the following study devices:
- You will be given a smartphone to take home with you.
- You will fill out a set of questions on the smartphone each time you exercise. The questions will ask about the kind physical activity you are participating in, the location of where the physical activity is taking place, and the weather conditions outside. These questions will take about 1-2 minutes per day. Also, the smartphone will "beep" at random times (3 times per day) and set times (in the morning and evening) throughout the day to prompt you to answer a set of questions about your thoughts and feelings. The device will also automatically record your location using a Global Positioning System (GPS) during the time you are carrying the phone. This will take about 7-8 minutes per day. The research staff will call you 1 time each week to remind you to use the smartphone and will help with any smartphone problems that may occur. Each reminder phone call should last about 3 minutes. You will return the smartphone with you at the orientation visit for the study staff to download your answers.
- You will be given an accelerometer. You will wear the accelerometer for 7 days and then return it at the orientation study visit. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.
Orientation Study Visit:
At the orientation study visit, the following tests and procedures will be performed:
- You will be given a newsletter that contains information and strategies to help you start your exercise program.
- You will be given a smartphone again to take home.
- You will be given a physical activity (PA) prescription. The PA prescription outlines your exercise program and has instructions on the proper way to walk to decrease the chance of getting an injury. You will be instructed to start your PA prescription and carry the smartphone with you for 2 weeks. After 2weeks, you will return the smartphone by mail in a prepaid envelope that will be provided to you by the study staff.
- You will be given a pedometer to wear when you are ready to start your PA prescription.
Weeks 8, 26, 39, and 52 Study Visits:
For each of these study visits, the following tests and procedures will be performed:
- You will return the accelerometer at each visit for the study staff to review, and you will take it home at the end of each visit. The staff member will provide you with the device at your Week 8 visit and you will receive an envelope for return. The smartphone will also be given to you at Weeks 26 and 39, and you will be required to mail it back. For Week 52 you will receive the device 1 week before and return it at your Week 52 visit. You should tell a research staff member right away about any problems you may have using the smartphone.
- You will complete the computer-based survey.
- Your blood pressure will be measured.
- Your height, weight, and waistline will be measured.
You will receive phone calls between study visits to remind you to complete the questions on the smartphone.
At the Weeks 26 and 52 study visits, in addition to the tests and procedures listed above, you will complete the fitness test again and return the smartphone.
Length of Study:
You will remain in the study for up to 1 year. Your participation on this study will be over after you complete the study visit at Week 52.
Other Information:
You may be contacted by phone, mail, text messaging, and/or email at any time while you are taking part in this study to be reminded about the study visits. You will be asked to give the names and contact information of family members and/or friends for the study staff to contact in the event they cannot reach you first.
This is an investigational study.
Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Cancer, Prevention Harmful Effects
- Being tested
- PA Prescription Plan, Pedometer, Newsletters
- Keywords
- Sedentary minority adult, Psychosocial factors, Environmental factors, Obesity, Physical Activity, PA, Cancer Risk, African Americans, Latino
- Medical subject headings
- Neoplasms, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA Prescription PlanBehavioural
Also called Physical Activity, Exercise
Exercise program and instructions.
PedometerDevice
Step monitor for individual PA progress.
NewslettersBehavioural
4 Newsletters with topics based on PA progression phases of adoption and maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Newsletters, Physical Activity (PA) Prescription Plan, Pedometer Receives: Behavioral: PA Prescription Plan; Device: Pedometer; Behavioral: Newsletters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Physical Activity Outcome
Physical Activity (PA) outcome measured at four time points post baseline (weeks 8, 26, 39, and 52)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study start16 Aug 2010
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 336 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
- Lorna H. McNeill, PHD, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195337
- Sponsor's protocol ID
- 2008-0763
- Status last verified
- Jan 2020
- First submitted
- 2 Sep 2010
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social, Contextual, and Environmental Determinants of Physical Activity in Sedentary Minority Adults
- ClinicalTrials.gov ID
- NCT01195337
- Acronym / sponsor ID
- 2008-0763
- Conditions
- Cancer, Prevention Harmful Effects
- Keywords
- Sedentary minority adult, Psychosocial factors, Environmental factors, Obesity, Physical Activity, PA, Cancer Risk, African Americans
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Aug 2010 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 6 Sep 2010 (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 goal of this study is to learn why some black and Latino men and women choose not to exercise very often. Researchers also want to learn more about any social and environmental factors that may affect the way an exercise program is followed.
Detailed description
If you chose to take part in this study, you will receive an exercise program, a pedometer, access to a social networking site, and newsletters to help you start becoming more physically active. A pedometer is a small device worn on the hip that counts the number of steps you have taken each day.
Study Visits:
You will come in for study visits 6 times while you are on study; 1 time at the beginning of the study called "screening", 1 time for an orientation visit 7 days after the screening visit, and for follow-up visits at 8, 26, 39, and 52 weeks after you begin the exercise program.
Baseline Tests:
If you are found to be eligible to take part on this study based on the results of the screening tests, the following tests and procedures will be performed:
- You will be asked to complete a computer-based survey. The questionnaires will ask questions about stress, your motivation for physical activity, any social support you may receive from others, the neighborhood you live in, and other physical activity-related topics. The questionnaires should take about 2 hours total to complete.
- Your blood pressure will be measured.
- Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
- You will complete a fitness test. To complete the fitness test, you will either walk a circular path at the clinic for 6 minutes or complete a step test. The study staff will decide which test you will complete and will discuss the test with you in more detail. A study staff member will monitor you during this test.
Study Devices:
At the baseline visit, you will be given the following study devices:
- You will be given a smartphone to take home with you.
- You will fill out a set of questions on the smartphone each time you exercise. The questions will ask about the kind physical activity you are participating in, the location of where the physical activity is taking place, and the weather conditions outside. These questions will take about 1-2 minutes per day. Also, the smartphone will "beep" at random times (3 times per day) and set times (in the morning and evening) throughout the day to prompt you to answer a set of questions about your thoughts and feelings. The device will also automatically record your location using a Global Positioning System (GPS) during the time you are carrying the phone. This will take about 7-8 minutes per day. The research staff will call you 1 time each week to remind you to use the smartphone and will help with any smartphone problems that may occur. Each reminder phone call should last about 3 minutes. You will return the smartphone with you at the orientation visit for the study staff to download your answers.
- You will be given an accelerometer. You will wear the accelerometer for 7 days and then return it at the orientation study visit. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.
Orientation Study Visit:
At the orientation study visit, the following tests and procedures will be performed:
- You will be given a newsletter that contains information and strategies to help you start your exercise program.
- You will be given a smartphone again to take home.
- You will be given a physical activity (PA) prescription. The PA prescription outlines your exercise program and has instructions on the proper way to walk to decrease the chance of getting an injury. You will be instructed to start your PA prescription and carry the smartphone with you for 2 weeks. After 2weeks, you will return the smartphone by mail in a prepaid envelope that will be provided to you by the study staff.
- You will be given a pedometer to wear when you are ready to start your PA prescription.
Weeks 8, 26, 39, and 52 Study Visits:
For each of these study visits, the following tests and procedures will be performed:
- You will return the accelerometer at each visit for the study staff to review, and you will take it home at the end of each visit. The staff member will provide you with the device at your Week 8 visit and you will receive an envelope for return. The smartphone will also be given to you at Weeks 26 and 39, and you will be required to mail it back. For Week 52 you will receive the device 1 week before and return it at your Week 52 visit. You should tell a research staff member right away about any problems you may have using the smartphone.
- You will complete the computer-based survey.
- Your blood pressure will be measured.
- Your height, weight, and waistline will be measured.
You will receive phone calls between study visits to remind you to complete the questions on the smartphone.
At the Weeks 26 and 52 study visits, in addition to the tests and procedures listed above, you will complete the fitness test again and return the smartphone.
Length of Study:
You will remain in the study for up to 1 year. Your participation on this study will be over after you complete the study visit at Week 52.
Other Information:
You may be contacted by phone, mail, text messaging, and/or email at any time while you are taking part in this study to be reminded about the study visits. You will be asked to give the names and contact information of family members and/or friends for the study staff to contact in the event they cannot reach you first.
This is an investigational study.
Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Behavioral: PA Prescription Plan, Device: Pedometer, Behavioral: NewslettersNewsletters, Physical Activity (PA) Prescription Plan, Pedometer |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 300 black or Latino participants in the greater Houston, Texas area.
Key inclusion criteria (7 listed)
- Black or Latino (self-defined by participant) ages 25-60 years
- Currently sedentary, defined as self-reported physical activity of </=90 minutes per week over the past 6 months
- Ready and physically able to start being physically active. Determined by asking participant if they intend to start being physically active within the next 30 days.
- Have a home address where information can be mailed
- Able to read English at a 6th grade level as assessed by the REALM
Key exclusion criteria (4 listed)
- Pregnant or thinking about becoming pregnant during the study period
- Another person in the same household is enrolled in the study
- Physical limitation that prevents engaging in PA
- MD Anderson employees who work in the Division of Cancer Prevention and Population Sciences
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 |
|---|---|---|
| PA Prescription PlanAlso: Physical Activity, ExerciseExercise program and instructions. | Behavioural | Study Group |
| PedometerStep monitor for individual PA progress. | Device | Study Group |
| Newsletters4 Newsletters with topics based on PA progression phases of adoption and maintenance. | Behavioural | Study Group |
Primary outcome
Participant Physical Activity Outcome
Time frame: 1 year
Physical Activity (PA) outcome measured at four time points post baseline (weeks 8, 26, 39, and 52)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- 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.
Lorna H. McNeill, PHD, MPH 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?
An observational study of Cancer and Prevention Harmful Effects, 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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?
Results are not available in the source record.
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?
Participant Physical Activity Outcome (time frame: 1 year). 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 13 Jan 2020.