Clinical trial NCT03656991: Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity
Official title: Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
name: UnitedHealthcare
First posted: 2018-09-04
Enrollment: 525
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body Mass Index
timeFrame: Change from Baseline BMI through study completion up to 78 weeks
measure: Change in Physical Activity
timeFrame: Change from Baseline Physical Activity through study completion up to 78 weeks
measure: Change in Sedentary Activity
timeFrame: Change from Baseline Sedentary Activity through study completion up to 78 weeks
Secondary outcomes:
measure: Change in Consumption of sugary drinks
timeFrame: Change from Baseline Consumption of Sugary Drinks through study completion up to 78 weeks
measure: Change in Consumption of Fast Food
timeFrame: Change from Baseline Consumption of Fast Food through study completion up to 78 weeks
measure: Change in Consumption of Fruits
timeFrame: Change from Baseline Consumption of Fruits through study completion up to 78 weeks
measure: Change in Consumption of Vegetables
timeFrame: Change from Baseline Consumption of Vegetables through study completion up to 78 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Maya Bunik, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: