Physical ActivityNCT02006186
Pilot and Feasibility Bicycle Train Study
A study testing Bicycle Train in people with Physical Activity, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
US children's active commuting to school (ACS; walking or cycling to school), previously common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity epidemic, which disproportionately affects low-income and ethnic minority children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Bicycle Train
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- attends a study school and is in the 4th or 5th grade,
- physically capable of riding a bicycle to and from school
- lives within approximately 2-miles of a study school
- has room at home to safely store a bicycle.
Who cannot join
- not in the 4th or 5th grade at a study school
- incapable of riding a bicycle to and from school
- lives beyond approximately 2-miles of a study school
- does not have room at home to safely store a bicycle
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: Pilot Study on Bicycle Trains to Improve Children's Physical Activity
US children's active commuting to school (ACS; walking or cycling to school), previously common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity epidemic, which disproportionately affects low-income and ethnic minority children. Programs to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity and related chronic disease risk are necessary. The Bicycle Train is an innovative program in which children cycle to and from school led by adults. Bicycle Trains provide another option for ACS, especially for children who live too far to walk to school. No randomized controlled trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing the percent of children who cycle to school is sub-objective PA-14 of US Healthy People 2020.
The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent accelerometer and GPS data and validate algorithms to identify and measure physical activity intensity and duration for children's cycling compared to heart rate monitors.
Read more
Our Specific Aims will be to:
SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned full-scale cluster RCT (b) promoting their participation, and (c) identifying barriers/facilitators to their participation; and SA2) validate algorithms examining concurrent accelerometry and global positioning system (GPS) data to identify and measure children's physical activity intensity and duration while cycling compared to the criterion standards of heart rate monitoring and direct observation
Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be determined to be feasible if:
FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program on average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer data have high agreement, i.e. >90% agreement, with heart rate data/direct observation in distinguishing children's cycling-related physical activity duration and intensity from other physical activities and riding in a motor vehicle
Read the detailed description
Physical activity decreases the risk of cardiovascular disease, Type 2 Diabetes, and multiple cancers, and is important for obesity prevention. US children's active commuting to school (ACS; walking or cycling to school), previously common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity epidemic, which disproportionately affects low-income and ethnic minority children. Programs to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity risk are necessary. The Bicycle Train is an innovative program in which children cycle to and from school led by adults. Bicycle Trains provide another option for ACS, especially for children who live too far to walk to school. No randomized controlled trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing the percent of children who cycle to school is sub-objective PA-14 of US Healthy People 2020.
The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent accelerometer and GPS data and validate algorithms to identify and measure physical activity intensity and duration for children's cycling compared to heart rate monitors. This pilot study will provide feasibility data and extend the validity of quantifying cycling-related MVPA for a future fully-powered R01-funded Bicycle Train cluster RCT.
Our Specific Aims will be to:
SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned full-scale cluster RCT (b) promoting their participation, and (c) identifying barriers/facilitators to their participation; and SA2) validate algorithms examining concurrent accelerometry and global positioning system (GPS) data to identify and measure children's physical activity intensity and duration while cycling compared to the criterion standards of heart rate monitoring and direct observation
Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be determined to be feasible if:
FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program on average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer data have high agreement, i.e. >90% agreement, with heart rate data/direct observation in distinguishing children's cycling-related physical activity duration and intensity from other physical activities and riding in a motor vehicle
This R21 application will provide important planning and methods validation targeted towards ethnic-minority children, the population at highest risk for childhood obesity in the US.
- Conditions
- Physical Activity
- Being tested
- Bicycle Train
- Keywords
- Bicycling
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicycle TrainBehavioural
The Bicycle Train intervention consists of research staff members who bike to and from school with enrolled participants
| Study group | Role | What they receive |
|---|---|---|
| Bicycle Train Intervention | Experimental | The Bicycle Train intervention consists of research staff members who bike to and from school with enrolled participants. All participants, regardless of group assignment, each receive a bicycle, safety equipment, and take a bicycle safety course. Receives: Behavioral: Bicycle Train |
| Control | No intervention | The control arm does not receive any intervention. All participants, regardless of group assignment, each receive a bicycle, safety equipment, and take a bicycle safety course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Intervention Bicycling to School
Mode of transport to school
Measured: During weeks 3-5 of the intervention
Secondary outcomes (3)
Pre-Intervention Moderate-to-vigorous physical activity (MVPA)
MVPA measured objectively by a combination of accelerometry and GPS data.
Measured: Baseline
Post-Intervention Moderate-to-vigorous physical activity (MVPA)
MVPA measured objectively by a combination of accelerometry and GPS data.
Measured: During weeks 3-5 of the intervention
Pre-Intervention Bicycling to School
Mode of transport to school
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionApr 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 Physical ActivityStudies 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
- None (open label)
- Enrolment
- 54 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
- NCT02006186
- Sponsor's protocol ID
- R21HL113810
- Status last verified
- Apr 2016
- First submitted
- 4 Dec 2013
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mendoza JA, Haaland W, Jacobs M, Abbey-Lambertz M, Miller J, Salls D, Todd W, Madding R, Ellis K, Kerr J. Bicycle Trains, Cycling, and Physical Activity: A Pilot Cluster RCT. Am J Prev Med. 2017 Oct;53(4):481-489. doi: 10.1016/j.amepre.2017.05.001. Epub 2017 Jun 28.
PubMed 28668251
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Bicycle Trains to Improve Children's Physical Activity
- ClinicalTrials.gov ID
- NCT02006186
- Acronym / sponsor ID
- R21HL113810
- Conditions
- Physical Activity
- Keywords
- Bicycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Dec 2013 (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.
US children's active commuting to school (ACS; walking or cycling to school), previously common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity epidemic, which disproportionately affects low-income and ethnic minority children. Programs to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity and related chronic disease risk are necessary. The Bicycle Train is an innovative program in which children cycle to and from school led by adults. Bicycle Trains provide another option for ACS, especially for children who live too far to walk to school. No randomized controlled trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing the percent of children who cycle to school is sub-objective PA-14 of US Healthy People 2020.
The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent accelerometer and GPS data and validate algorithms to identify and measure physical activity intensity and duration for children's cycling compared to heart rate monitors.
Our Specific Aims will be to:
SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned full-scale cluster RCT (b) promoting their participation, and (c) identifying barriers/facilitators to their participation; and SA2) validate algorithms examining concurrent accelerometry and global positioning system (GPS) data to identify and measure children's physical activity intensity and duration while cycling compared to the criterion standards of heart rate monitoring and direct observation
Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be determined to be feasible if:
FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program on average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer data have high agreement, i.e. >90% agreement, with heart rate data/direct observation in distinguishing children's cycling-related physical activity duration and intensity from other physical activities and riding in a motor vehicle
Detailed description
Physical activity decreases the risk of cardiovascular disease, Type 2 Diabetes, and multiple cancers, and is important for obesity prevention. US children's active commuting to school (ACS; walking or cycling to school), previously common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity epidemic, which disproportionately affects low-income and ethnic minority children. Programs to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity risk are necessary. The Bicycle Train is an innovative program in which children cycle to and from school led by adults. Bicycle Trains provide another option for ACS, especially for children who live too far to walk to school. No randomized controlled trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing the percent of children who cycle to school is sub-objective PA-14 of US Healthy People 2020.
The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent accelerometer and GPS data and validate algorithms to identify and measure physical activity intensity and duration for children's cycling compared to heart rate monitors. This pilot study will provide feasibility data and extend the validity of quantifying cycling-related MVPA for a future fully-powered R01-funded Bicycle Train cluster RCT.
Our Specific Aims will be to:
SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned full-scale cluster RCT (b) promoting their participation, and (c) identifying barriers/facilitators to their participation; and SA2) validate algorithms examining concurrent accelerometry and global positioning system (GPS) data to identify and measure children's physical activity intensity and duration while cycling compared to the criterion standards of heart rate monitoring and direct observation
Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be determined to be feasible if:
FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program on average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer data have high agreement, i.e. >90% agreement, with heart rate data/direct observation in distinguishing children's cycling-related physical activity duration and intensity from other physical activities and riding in a motor vehicle
This R21 application will provide important planning and methods validation targeted towards ethnic-minority children, the population at highest risk for childhood obesity in the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bicycle Train Intervention | Experimental | Behavioral: Bicycle TrainThe Bicycle Train intervention consists of research staff members who bike to and from school with enrolled participants. All participants, regardless of group assignment, each receive a bicycle, safety equipment, and take a bicycle safety course. |
| Control | No intervention | –The control arm does not receive any intervention. All participants, regardless of group assignment, each receive a bicycle, safety equipment, and take a bicycle safety course. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- attends a study school and is in the 4th or 5th grade,
- physically capable of riding a bicycle to and from school
- lives within approximately 2-miles of a study school
- has room at home to safely store a bicycle.
Key exclusion criteria (4 listed)
- not in the 4th or 5th grade at a study school
- incapable of riding a bicycle to and from school
- lives beyond approximately 2-miles of a study school
- does not have room at home to safely store a bicycle
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 |
|---|---|---|
| Bicycle TrainThe Bicycle Train intervention consists of research staff members who bike to and from school with enrolled participants | Behavioural | Bicycle Train Intervention |
Primary outcome
Post-Intervention Bicycling to School
Time frame: During weeks 3-5 of the intervention
Mode of transport to school
3 secondary outcomes
Pre-Intervention Moderate-to-vigorous physical activity (MVPA)
Time frame: Baseline
Post-Intervention Moderate-to-vigorous physical activity (MVPA)
Time frame: During weeks 3-5 of the intervention
Pre-Intervention Bicycling to School
Time frame: Baseline
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 13 Apr 2016.
- Derived from this study: PubMed 28668251Mendoza JA, Haaland W, Jacobs M, Abbey-Lambertz M, Miller J, Salls D, Todd W, Madding R, Ellis K, Kerr J. Bicycle Trains, Cycling, and Physical Activity: A Pilot Cluster RCT. Am J Prev Med. 2017 Oct;53(4):481-489. doi: 10.1016/j.amepre.2017.05.001. Epub 2017 Jun 28.
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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 Bicycle Train in people with 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 4 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: finished, as of the sponsor's last update on 13 Apr 2016. 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?
Post-Intervention Bicycling to School (time frame: During weeks 3-5 of the 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 NCT02006186, 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 13 Apr 2016.