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

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656991
• Other study ID #: 12-0344
• Status: Completed
• Phase: N/A
• Start date: April 6, 2012
• Est. completion date: April 4, 2018

Study information

• Verified date: August 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: April 4, 2018
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Other:
• Bicycle intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado, UnitedHealthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index		Change from Baseline BMI through study completion up to 78 weeks
Primary	Change in Physical Activity	Average time spent participating in physical activity	Change from Baseline Physical Activity through study completion up to 78 weeks
Primary	Change in Sedentary Activity	Average time spent in sedentary activities	Change from Baseline Sedentary Activity through study completion up to 78 weeks
Secondary	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
Secondary	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
Secondary	Change in Consumption of Fruits	Number of fruits consumed	Change from Baseline Consumption of Fruits through study completion up to 78 weeks
Secondary	Change in Consumption of Vegetables	Number of vegetables consumed	Change from Baseline Consumption of Vegetables through study completion up to 78 weeks