Social Contextual Influences on Physical Activity
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 2, 2010 | ||||||||
| Last Updated Date | February 12, 2013 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Participant Physical Activity Outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ] Physical Activity (PA) outcome measured at four time points post baseline (weeks 8, 26, 39, and 52) |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01195337 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Social Contextual Influences on Physical Activity | ||||||||
| Official Title ICMJE | Social, Contextual, and Environmental Determinants of Physical Activity in Sedentary Minority Adults | ||||||||
| Brief 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. |
||||||||
| 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:
Study Devices: At the baseline visit, you will be given the following study devices:
Orientation Study Visit: At the orientation study visit, the following tests and procedures will be performed:
Weeks 8, 26, 39, and 52 Study Visits For each of these study visits, the following tests and procedures will be performed:
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. |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | 300 black or Latino participants in the greater Houston, Texas area. |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE |
|
||||||||
| Study Group/Cohort (s) | Study Group
Newsletters, Physical Activity (PA) Prescription Plan, Pedometer
Interventions:
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 380 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 25 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01195337 | ||||||||
| Other Study ID Numbers ICMJE | 2008-0763 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | M.D. Anderson Cancer Center | ||||||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | M.D. Anderson Cancer Center | ||||||||
| Verification Date | February 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||