An interventional study of Bicycle intervention in Obesity, Childhood, sponsored by University of Colorado, Denver. Completed. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-09-04.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 525 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receive the bicycle intervention at 0 months after enrollment.
Other: Bicycle intervention
Receive the bicycle intervention at 2 months after enrollment.
Other: Bicycle intervention
Receive the bicycle intervention at 4 months after enrollment.
Other: Bicycle intervention
Receive the bicycle intervention at 6 months after enrollment.
Other: Bicycle intervention
Change in Body Mass Index
Time frame: Change from Baseline BMI through study completion up to 78 weeks
Change in Physical Activity
Average time spent participating in physical activity
Time frame: Change from Baseline Physical Activity through study completion up to 78 weeks
Change in Sedentary Activity
Average time spent in sedentary activities
Time frame: Change from Baseline Sedentary Activity through study completion up to 78 weeks
Change in Consumption of sugary drinks
Number of sugary drinks consumed
Time frame: 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
Time frame: Change from Baseline Consumption of Fast Food through study completion up to 78 weeks
Change in Consumption of Fruits
Number of fruits consumed
Time frame: Change from Baseline Consumption of Fruits through study completion up to 78 weeks
Change in Consumption of Vegetables
Number of vegetables consumed
Time frame: Change from Baseline Consumption of Vegetables through study completion up to 78 weeks
No study locations are listed for this record.
Plan to share: No — IPD will not be shared outside of the study.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver