Obesity, ChildhoodNCT03656991
Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity
A study testing Bicycle intervention in people with Obesity, Childhood, run by University of Colorado, Denver.
Trial summary
The investigators propose a study to evaluate the success of a bicycle distribution program in increasing physical activity level, decreasing sedentary activity levels and positively affecting body-mass index (BMI) in participants aged 6 to 12 years old with overweight or obesity, who do not already own a bicycle, and… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Bicycle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- No sites listed yet
- Study dates
- 6 Apr 2012to 4 Apr 2018
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 6-12 years
- Do not own a bicycle
- BMI over 85% for age (overweight or obese)
Who cannot join
- Outside of state age range
- Not overweight or obese
- Already own a bicycle.
About this study
The investigators propose a study to evaluate the success of a bicycle distribution program in increasing physical activity level, decreasing sedentary activity levels and positively affecting body-mass index (BMI) in participants aged 6 to 12 years old with overweight or obesity, who do not already own a bicycle, and are patients at the Children's Hospital Colorado Child Health Clinic (CHC), Lifestyle Medicine Clinic, or Rocky Mountain Youth Clinics. The investigators anticipate that the receipt of a bicycle will increase physical activity level, decrease sedentary activity time and decrease or stabilize patients' BMI. The investigators will answer this research question by distributing bicycles to 525 children and conducting follow up visits over the course of a year to measure the outcomes of interest.
- Conditions
- Obesity, Childhood
- Being tested
- Bicycle intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicycle interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 0 month group | Experimental | Receive the bicycle intervention at 0 months after enrollment. Receives: Other: Bicycle intervention |
| 2 month group | Experimental | Receive the bicycle intervention at 2 months after enrollment. Receives: Other: Bicycle intervention |
| 4 month group | Experimental | Receive the bicycle intervention at 4 months after enrollment. Receives: Other: Bicycle intervention |
| 6 month group | Experimental | Receive the bicycle intervention at 6 months after enrollment. Receives: Other: Bicycle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index
Measured: Change from Baseline BMI through study completion up to 78 weeks
Change in Physical Activity
Average time spent participating in physical activity
Measured: Change from Baseline Physical Activity through study completion up to 78 weeks
Change in Sedentary Activity
Average time spent in sedentary activities
Measured: Change from Baseline Sedentary Activity through study completion up to 78 weeks
Secondary outcomes (4)
Change in Consumption of sugary drinks
Number of sugary drinks consumed
Measured: Change from Baseline Consumption of Sugary Drinks through study completion up to 78 weeks
Change in Consumption of Fast Food
Number of times fast food was consumed
Measured: Change from Baseline Consumption of Fast Food through study completion up to 78 weeks
Change in Consumption of Fruits
Number of fruits consumed
Measured: Change from Baseline Consumption of Fruits through study completion up to 78 weeks
Change in Consumption of Vegetables
Number of vegetables consumed
Measured: Change from Baseline Consumption of Vegetables through study completion up to 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start6 Apr 2012
- Primary completion25 Oct 2016
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a stepped-wedge, randomized controlled trial. Possible subjects will be randomized to 1 of 4 groups. Each patient will serve as his or her own control. Within each stratum of four, patients will be randomly assigned to intervention initiation times (\~130 per initiation time). Intervention initiation times will occur every other month up to a maximum of six months.
- Masking
- None (open label)
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado, UnitedHealthcare
- Responsible party
- Sponsor
- Investigators
- Maya Bunik, MD, MSPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656991
- Sponsor's protocol ID
- 12-0344
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside of the study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity
- ClinicalTrials.gov ID
- NCT03656991
- Acronym / sponsor ID
- 12-0344
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado, UnitedHealthcare
- Study start
- 6 Apr 2012 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 4 Sep 2018 (actual)
- 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 investigators propose a study to evaluate the success of a bicycle distribution program in increasing physical activity level, decreasing sedentary activity levels and positively affecting body-mass index (BMI) in participants aged 6 to 12 years old with overweight or obesity, who do not already own a bicycle, and are patients at the Children's Hospital Colorado Child Health Clinic (CHC), Lifestyle Medicine Clinic, or Rocky Mountain Youth Clinics. The investigators anticipate that the receipt of a bicycle will increase physical activity level, decrease sedentary activity time and decrease or stabilize patients' BMI. The investigators will answer this research question by distributing bicycles to 525 children and conducting follow up visits over the course of a year to measure the outcomes of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a stepped-wedge, randomized controlled trial. Possible subjects will be randomized to 1 of 4 groups. Each patient will serve as his or her own control. Within each stratum of four, patients will be randomly assigned to intervention initiation times (~130 per initiation time). Intervention initiation times will occur every other month up to a maximum of six months.
| Arm | Type | Receives |
|---|---|---|
| 0 month group | Experimental | Other: Bicycle interventionReceive the bicycle intervention at 0 months after enrollment. |
| 2 month group | Experimental | Other: Bicycle interventionReceive the bicycle intervention at 2 months after enrollment. |
| 4 month group | Experimental | Other: Bicycle interventionReceive the bicycle intervention at 4 months after enrollment. |
| 6 month group | Experimental | Other: Bicycle interventionReceive the bicycle intervention at 6 months after enrollment. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 6-12 years
- Do not own a bicycle
- BMI over 85% for age (overweight or obese)
Key exclusion criteria (3 listed)
- Outside of state age range
- Not overweight or obese
- Already own 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 intervention | Other | 0 month group, 2 month group, 4 month group, 6 month group |
Primary outcome
Change in Body Mass Index
Time frame: Change from Baseline BMI through study completion up to 78 weeks
Change in Physical Activity
Time frame: Change from Baseline Physical Activity through study completion up to 78 weeks
Average time spent participating in physical activity
Change in Sedentary Activity
Time frame: Change from Baseline Sedentary Activity through study completion up to 78 weeks
Average time spent in sedentary activities
4 secondary outcomes
Change in Consumption of sugary drinks
Time frame: Change from Baseline Consumption of Sugary Drinks through study completion up to 78 weeks
Change in Consumption of Fast Food
Time frame: Change from Baseline Consumption of Fast Food through study completion up to 78 weeks
Change in Consumption of Fruits
Time frame: Change from Baseline Consumption of Fruits through study completion up to 78 weeks
Change in Consumption of Vegetables
Time frame: Change from Baseline Consumption of Vegetables through study completion up to 78 weeks
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 4 Sep 2018.
- Individual participant dataSharing planned: No. IPD will not be shared outside of the study.
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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.
Maya Bunik, MD, MSPH principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Bicycle intervention in people with Obesity, Childhood, run by University of Colorado, Denver.
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 3 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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Body Mass Index (time frame: Change from Baseline BMI through study completion up to 78 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2018.