Physical ActivityPhase 2NCT00186134
Walk to School and Physical Activity
A Phase 2 study testing physical activity in people with Physical Activity, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the proposed study is to determine the effect of walking to school for one week on total physical activity and patterns of physical activity in third, fourth and fifth grade students. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to May 2005
- Phase
- Phase 2
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3rd, 4th, or 5th grade at participating school
Who cannot join
- Currently walking or bicycling to school at least 4 times per week
- Physical or mental disability that would prevent walking to school under adult supervision.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of the proposed study is to determine the effect of walking to school for one week on total physical activity and patterns of physical activity in third, fourth and fifth grade students.
Read the detailed description
Increasing children's physical activity has become an important public health concern. Active transportation (walking and bicycling) is one aspect of children's physical activity that has received little attention but may provide a means of increasing children's activity levels. Traveling to school is a common activity for most children in the United States. Due to this regularity, active transportation to school provides a possible way to incorporate an increase in children's moderate-to-vigorous physical activity into a routine activity.
Several "walk to school" programs have been implemented but it is not known if the physical activity levels of children walking to school are greater than those that get chauffeured or bused. Theoretically, moderate intensity activity should be greater in the walkers compared to others. This difference should be in proportion to the duration of the walk to and from school; determined by how far the child lives from the school. However, more activity in the morning may have an impact on activity levels later in the day. Therefore, differences in daily activity patterns in addition to total activity need to be considered.
Comparison(s): Following a baseline week, the physical activity of students randomized to a Walk to School group will be compared to those randomized to a Control group, who will continue to be driven to school.
- Conditions
- Physical Activity
- Being tested
- physical activity
- Keywords
- Physical Activity, Walking, Primary Schools, Transportation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer derived average minutes of moderate-to-vigorous physical activity per day.
Accelerometer derived average counts per minute per day.
Secondary outcomes (2)
Accelerometer derived average minutes of moderate-to-vigorous physical activity before, during, and after school and in the evening.
Accelerometer derived average counts per minute per day before, during, and after school and in the evening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- John R Sirard, PhD, Principal investigator, Stanford UniversityThomas N Robinson, MD, MPH, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186134
- Sponsor's protocol ID
- 95378
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Publications
Boarnet MG, Anderson CL, Day K, McMillan T, Alfonzo M. Evaluation of the California Safe Routes to School legislation: urban form changes and children's active transportation to school. Am J Prev Med. 2005 Feb;28(2 Suppl 2):134-40. doi: 10.1016/j.amepre.2004.10.026.
PubMed 15694521Gordon-Larsen P, Nelson MC, Beam K. Associations among active transportation, physical activity, and weight status in young adults. Obes Res. 2005 May;13(5):868-75. doi: 10.1038/oby.2005.100.
PubMed 15919840Sirard JR, Ainsworth BE, McIver KL, Pate RR. Prevalence of active commuting at urban and suburban elementary schools in Columbia, SC. Am J Public Health. 2005 Feb;95(2):236-7. doi: 10.2105/AJPH.2003.034355.
PubMed 15671456
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk to School and Physical Activity
- ClinicalTrials.gov ID
- NCT00186134
- Acronym / sponsor ID
- 95378
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Walking, Primary Schools, Transportation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2004
- Study completion
- May 2005
- First posted
- 16 Sep 2005 (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 purpose of the proposed study is to determine the effect of walking to school for one week on total physical activity and patterns of physical activity in third, fourth and fifth grade students.
Detailed description
Increasing children's physical activity has become an important public health concern. Active transportation (walking and bicycling) is one aspect of children's physical activity that has received little attention but may provide a means of increasing children's activity levels. Traveling to school is a common activity for most children in the United States. Due to this regularity, active transportation to school provides a possible way to incorporate an increase in children's moderate-to-vigorous physical activity into a routine activity.
Several "walk to school" programs have been implemented but it is not known if the physical activity levels of children walking to school are greater than those that get chauffeured or bused. Theoretically, moderate intensity activity should be greater in the walkers compared to others. This difference should be in proportion to the duration of the walk to and from school; determined by how far the child lives from the school. However, more activity in the morning may have an impact on activity levels later in the day. Therefore, differences in daily activity patterns in addition to total activity need to be considered.
Comparison(s): Following a baseline week, the physical activity of students randomized to a Walk to School group will be compared to those randomized to a Control group, who will continue to be driven to school.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 3rd, 4th, or 5th grade at participating school
Key exclusion criteria (2 listed)
- Currently walking or bicycling to school at least 4 times per week
- Physical or mental disability that would prevent walking to school under adult supervision.
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 | Behavioural | – |
Primary outcome
Accelerometer derived average minutes of moderate-to-vigorous physical activity per day.
Accelerometer derived average counts per minute per day.
2 secondary outcomes
Accelerometer derived average minutes of moderate-to-vigorous physical activity before, during, and after school and in the evening.
Accelerometer derived average counts per minute per day before, during, and after school and in the evening.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2005.
- Background: PubMed 15694521Boarnet MG, Anderson CL, Day K, McMillan T, Alfonzo M. Evaluation of the California Safe Routes to School legislation: urban form changes and children's active transportation to school. Am J Prev Med. 2005 Feb;28(2 Suppl 2):134-40. doi: 10.1016/j.amepre.2004.10.026.
- Background: PubMed 15919840Gordon-Larsen P, Nelson MC, Beam K. Associations among active transportation, physical activity, and weight status in young adults. Obes Res. 2005 May;13(5):868-75. doi: 10.1038/oby.2005.100.
- Background: PubMed 15671456Sirard JR, Ainsworth BE, McIver KL, Pate RR. Prevalence of active commuting at urban and suburban elementary schools in Columbia, SC. Am J Public Health. 2005 Feb;95(2):236-7. doi: 10.2105/AJPH.2003.034355.
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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.
John R Sirard, PhD principal investigator
Stanford University
Thomas N Robinson, MD, MPH study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing physical activity in people with Physical Activity, run by Stanford University 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 1 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: finished, as of the sponsor's last update on 16 Sep 2005. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accelerometer derived average minutes of moderate-to-vigorous physical activity per day.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00186134, which also lists 3 linked publications.
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 16 Sep 2005.