ObesityNCT01626807
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
Just two generations ago, walking or bicycling to school was the norm for a substantial number of US children, e.g. 48% of children walked or biked to school in 1969 versus only 13% in 2009. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity
- 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
- 838 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2016
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- physically capable of walking to and from school
- live within 1-mile of school or parents agree to regularly drop off children within 1-mile of school
- attend a study school and enrolled in 3rd, 4th, or 5th grade
Who cannot join
- another child from the same household is enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98145-5005
About this study
Official title: Evaluation of a Walking School Bus Program: A Cluster Randomized Controlled Trial
Just two generations ago, walking or bicycling to school was the norm for a substantial number of US children, e.g. 48% of children walked or biked to school in 1969 versus only 13% in 2009. This decline occurred in the same timeframe as the childhood obesity epidemic, which is at record high levels in the US and affects low-income and ethnic minority children the most. This project will test "the walking school bus" (WSB) program, in which children walk to and from school with adults, and its impact on low-income, ethnic minority children's walking to school, physical activity, and risk for obesity. Ultimately, this line of research has the potential to provide a low-cost, easy to disseminate program to reduce risk of obesity and cancer for at-risk children.
The investigators Specific Aims among 3rd-5th grade children include:
Read more
SA1) To recruit 770 child-parent dyads from 22 elementary schools over 4 years and conduct a cluster randomized controlled trial to assess the efficacy of a WSB program on children's walking to school, physical activity, and BMI z-score over a school-year SA2) To collect and analyze data on individual-, school-, and macro-level influences on changes to children's walking to school resulting from the WSB program
The Primary Hypotheses to be tested, in comparison to control children, include:
H1) The WSB program will increase children's walking to school over a school-year.
H1a) Parents' outcome expectations and self-efficacy will mediate the relationship between the WSB and changes to children's walking to school.
H1b) Walkability, safety, and acculturation will moderate changes to children's walking to school.
H2) The WSB program will increase children's physical activity and decrease BMI z-scores over a school-year.
H3) The WSB program will increase school-level pedestrian safety behaviors over a school-year.
- Conditions
- Obesity, Physical Activity
- Being tested
- Walking School Bus
- Keywords
- Safe Routes to School, Walking School Bus, Cluster Randomized Controlled Trial, Physical Activity, Obesity, Overweight
- Medical subject headings
- Obesity, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking School BusBehavioural
Children will have the option of walking to and/or from school with study staff who are trained in Safe Routes to School methods.
| Study group | Role | What they receive |
|---|---|---|
| Walking school bus | Experimental | Not described Receives: Behavioral: Walking School Bus |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly rate of children's active commuting to school
Measured: 5-6 months
Secondary outcomes (2)
Moderate-to-vigorous physical activity
Measured: 5-6 months
Body mass index z-score
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2016
- Study completionDec 2016
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.
- More trials run by Seattle Children's HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 838 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
- NCT01626807
- Sponsor's protocol ID
- 1R01CA163146-01A1
- Status last verified
- Apr 2017
- First submitted
- 21 Jun 2012
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson AM, Zhou C, Haviland M, Mendoza JA. Evaluation of a walking school bus program: a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2024 May 10;21(1):55. doi: 10.1186/s12966-024-01602-w.
PubMed 38730407
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Walking School Bus Program: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01626807
- Acronym / sponsor ID
- 1R01CA163146-01A1
- Conditions
- Obesity, Physical Activity
- Keywords
- Safe Routes to School, Walking School Bus, Cluster Randomized Controlled Trial, Physical Activity, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 838 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Jun 2012 (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.
Just two generations ago, walking or bicycling to school was the norm for a substantial number of US children, e.g. 48% of children walked or biked to school in 1969 versus only 13% in 2009. This decline occurred in the same timeframe as the childhood obesity epidemic, which is at record high levels in the US and affects low-income and ethnic minority children the most. This project will test "the walking school bus" (WSB) program, in which children walk to and from school with adults, and its impact on low-income, ethnic minority children's walking to school, physical activity, and risk for obesity. Ultimately, this line of research has the potential to provide a low-cost, easy to disseminate program to reduce risk of obesity and cancer for at-risk children.
The investigators Specific Aims among 3rd-5th grade children include:
SA1) To recruit 770 child-parent dyads from 22 elementary schools over 4 years and conduct a cluster randomized controlled trial to assess the efficacy of a WSB program on children's walking to school, physical activity, and BMI z-score over a school-year SA2) To collect and analyze data on individual-, school-, and macro-level influences on changes to children's walking to school resulting from the WSB program
The Primary Hypotheses to be tested, in comparison to control children, include:
H1) The WSB program will increase children's walking to school over a school-year.
H1a) Parents' outcome expectations and self-efficacy will mediate the relationship between the WSB and changes to children's walking to school.
H1b) Walkability, safety, and acculturation will moderate changes to children's walking to school.
H2) The WSB program will increase children's physical activity and decrease BMI z-scores over a school-year.
H3) The WSB program will increase school-level pedestrian safety behaviors over a school-year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking school bus | Experimental | Behavioral: Walking School Bus |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- physically capable of walking to and from school
- live within 1-mile of school or parents agree to regularly drop off children within 1-mile of school
- attend a study school and enrolled in 3rd, 4th, or 5th grade
Key exclusion criteria (1 listed)
- another child from the same household is enrolled in the study
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 BusChildren will have the option of walking to and/or from school with study staff who are trained in Safe Routes to School methods. | Behavioural | Walking school bus |
Primary outcome
Weekly rate of children's active commuting to school
Time frame: 5-6 months
2 secondary outcomes
Moderate-to-vigorous physical activity
Time frame: 5-6 months
Body mass index z-score
Time frame: 5-6 months
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 25 Apr 2017.
- Derived from this study: PubMed 38730407Johnson AM, Zhou C, Haviland M, Mendoza JA. Evaluation of a walking school bus program: a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2024 May 10;21(1):55. doi: 10.1186/s12966-024-01602-w.
- Walking School Bus GuidelinesLink 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.
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 3 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 25 Apr 2017. 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?
Weekly rate of children's active commuting to school (time frame: 5-6 months). 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 NCT01626807, 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 25 Apr 2017.