ObesityNCT00758615
Pilot Evaluation of a Walking School Bus Program
A study testing Walking School Bus in people with Obesity and Physical Activity, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Walking to school is one of the objectives for children and adolescents in Healthy People 2010 and in previous studies was associated with higher levels of overall physical activity, which has been shown to decrease obesity. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity, Pedestrian Safety
- What is being tested?
- Walking School Bus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2009
- Phase
- Interventional
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4th grade student at a study school in the Houston Independent School District
- Must be physically able to walk to and from school
Who cannot join
- Any condition that would prevent the student from walking to or from school
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot and Feasibility Evaluation of a Walking School Bus Program Intervention for Elementary School Students
Walking to school is one of the objectives for children and adolescents in Healthy People 2010 and in previous studies was associated with higher levels of overall physical activity, which has been shown to decrease obesity. Therefore, more children walking to school should result in increased physical activity and presumably reduce obesity. However, increasing child pedestrian activity could increase the risk of child pedestrian injuries. Walking with an adult who provides instruction in pedestrian skills and monitors the child's actual behavior may be the most important component of a successful intervention. Walking with an adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB) addresses safety concerns by providing a period of physical activity supervised by several responsible adults and teaching opportunities around pedestrian safety skills on the way to and from school. Children may join the WSB at various points along the set route. Despite the growing popularity of WSB programs in the United States, randomized, controlled-studies are lacking that examine the impact on children's safety, physical activity, and health. We seek to help fill this gap in the literature by piloting a WSB program in elementary schools in the Houston Independent School District to test feasibility. We hypothesize that a WSB program will: (1) increase the number of students walking to school and decrease the number of students driven to school by car, (2) increase students' pedestrian safety behaviors (3) increase students' physical activity, and (4) decrease students' excess weight gain.
- Conditions
- Obesity, Physical Activity, Pedestrian Safety, Injury Prevention
- Being tested
- Walking School Bus
- Keywords
- Obesity, Physical activity, Injury Prevention, Pedestrian safety, Self efficacy, School, Walking School Bus, Safe Routes to School
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking School BusBehavioural
Also called Safe Routes to School
Students are chaperoned to and from school by adults (study staff or parent volunteers) along set routes.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Walking School Bus Intervention Receives: Behavioral: Walking School Bus |
| C | No intervention | Usual school procedures for student transportation to school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method of student transportation to school
Measured: Immediately pre- and post-intervention
Secondary outcomes (4)
Physical activity
Physical activity objectively measured by accelerometers.
Measured: Immediately pre- and post-intervention
Pedestrian crosswalk behavior
Measured: Immediately pre- and post-intervention
Parents' psychosocial constructs related to allowing their child to walk to school
Measured: Immediately pre- and post-intervention
Child's self-efficacy for walking to school
Measured: Immediately pre- and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Mendoza, Seattle Children's Hospital
- Investigators
- Jason A Mendoza, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758615
- Sponsor's protocol ID
- 1R21CA133418-01
- Other IDs
- 163773
- Status last verified
- Dec 2013
- First submitted
- 22 Sep 2008
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Mendoza JA, Watson K, Baranowski T, Nicklas TA, Uscanga DK, Hanfling MJ. The walking school bus and children's physical activity: a pilot cluster randomized controlled trial. Pediatrics. 2011 Sep;128(3):e537-44. doi: 10.1542/peds.2010-3486. Epub 2011 Aug 22.
PubMed 21859920
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Feasibility Evaluation of a Walking School Bus Program Intervention for Elementary School Students
- ClinicalTrials.gov ID
- NCT00758615
- Acronym / sponsor ID
- 1R21CA133418-01
- Conditions
- Obesity, Physical Activity, Pedestrian Safety, Injury Prevention
- Keywords
- Obesity, Physical activity, Injury Prevention, Pedestrian safety, Self efficacy, School, Walking School Bus, Safe Routes to School
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Sep 2008 (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.
Walking to school is one of the objectives for children and adolescents in Healthy People 2010 and in previous studies was associated with higher levels of overall physical activity, which has been shown to decrease obesity. Therefore, more children walking to school should result in increased physical activity and presumably reduce obesity. However, increasing child pedestrian activity could increase the risk of child pedestrian injuries. Walking with an adult who provides instruction in pedestrian skills and monitors the child's actual behavior may be the most important component of a successful intervention. Walking with an adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB) addresses safety concerns by providing a period of physical activity supervised by several responsible adults and teaching opportunities around pedestrian safety skills on the way to and from school. Children may join the WSB at various points along the set route. Despite the growing popularity of WSB programs in the United States, randomized, controlled-studies are lacking that examine the impact on children's safety, physical activity, and health. We seek to help fill this gap in the literature by piloting a WSB program in elementary schools in the Houston Independent School District to test feasibility. We hypothesize that a WSB program will: (1) increase the number of students walking to school and decrease the number of students driven to school by car, (2) increase students' pedestrian safety behaviors (3) increase students' physical activity, and (4) decrease students' excess weight gain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: Walking School BusWalking School Bus Intervention |
| C | No intervention | –Usual school procedures for student transportation to school |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 4th grade student at a study school in the Houston Independent School District
- Must be physically able to walk to and from school
Key exclusion criteria (1 listed)
- Any condition that would prevent the student from walking to or from school
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 |
|---|---|---|
| Walking School BusAlso: Safe Routes to SchoolStudents are chaperoned to and from school by adults (study staff or parent volunteers) along set routes. | Behavioural | I |
Primary outcome
Method of student transportation to school
Time frame: Immediately pre- and post-intervention
4 secondary outcomes
Physical activity
Time frame: Immediately pre- and post-intervention
Pedestrian crosswalk behavior
Time frame: Immediately pre- and post-intervention
Parents' psychosocial constructs related to allowing their child to walk to school
Time frame: Immediately pre- and post-intervention
Child's self-efficacy for walking to school
Time frame: Immediately pre- and post-intervention
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 6 Dec 2013.
- Derived from this study: PubMed 21859920Mendoza JA, Watson K, Baranowski T, Nicklas TA, Uscanga DK, Hanfling MJ. The walking school bus and children's physical activity: a pilot cluster randomized controlled trial. Pediatrics. 2011 Sep;128(3):e537-44. doi: 10.1542/peds.2010-3486. Epub 2011 Aug 22.
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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.
Jason A Mendoza, MD, MPH principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking School Bus in people with Obesity and Physical Activity, run by Seattle Children's Hospital 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 2 inclusion and 1 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 6 Dec 2013. 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?
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?
Method of student transportation to school (time frame: Immediately pre- and post-intervention). 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 NCT00758615, which also lists 1 linked publication.
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 6 Dec 2013.