Obesity, Childhood
Conditions
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.
Interventions
OTHERBicycle intervention
Sponsors
Children's Hospital Colorado
UnitedHealthcare
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index | Change from Baseline BMI through study completion up to 78 weeks | — |
| Change in Physical Activity | Change from Baseline Physical Activity through study completion up to 78 weeks | Average time spent participating in physical activity |
| Change in Sedentary Activity | Change from Baseline Sedentary Activity through study completion up to 78 weeks | Average time spent in sedentary activities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Consumption of sugary drinks | Change from Baseline Consumption of Sugary Drinks through study completion up to 78 weeks | Number of sugary drinks consumed |
| Change in Consumption of Vegetables | Change from Baseline Consumption of Vegetables through study completion up to 78 weeks | Number of vegetables consumed |
| Change in Consumption of Fast Food | Change from Baseline Consumption of Fast Food through study completion up to 78 weeks | Number of times fast food was consumed |
| Change in Consumption of Fruits | Change from Baseline Consumption of Fruits through study completion up to 78 weeks | Number of fruits consumed |
Outcome results
None listed