Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Other: Bicycle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 6-12 years Do not own a bicycle BMI over 85% for age (overweight or obese) Exclusion Criteria: Outside of state age range Not overweight or obese Already own a bicycle.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0 month group<br>Receive the bicycle intervention at 0 months after enrollment. | Other: Bicycle intervention<br> <br> |
| Experimental: 2 month group<br>Receive the bicycle intervention at 2 months after enrollment. | Other: Bicycle intervention<br> <br> |
| Experimental: 4 month group<br>Receive the bicycle intervention at 4 months after enrollment. | Other: Bicycle intervention<br> <br> |
| Experimental: 6 month group<br>Receive the bicycle intervention at 6 months after enrollment. | Other: Bicycle intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index |  | Change from Baseline BMI through study completion up to 78 weeks | 
| Change in Physical Activity | Average time spent participating in physical activity | Change from Baseline Physical Activity through study completion up to 78 weeks | 
| Change in Sedentary Activity | Average time spent in sedentary activities | Change from Baseline Sedentary Activity through study completion up to 78 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Consumption of sugary drinks | Number of sugary drinks consumed | 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 | Change from Baseline Consumption of Fast Food through study completion up to 78 weeks | 
| Change in Consumption of Fruits | Number of fruits consumed | Change from Baseline Consumption of Fruits through study completion up to 78 weeks | 
| Change in Consumption of Vegetables | Number of vegetables consumed | Change from Baseline Consumption of Vegetables through study completion up to 78 weeks |