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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Other: Bicycle intervention

• Study Type: Interventional
• Enrollment (Actual): 525
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado; UnitedHealthcare
• Investigators: Principal Investigator: Maya Bunik, MD, MSPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2012
• Primary Completion (Actual): October 25, 2016
• Study Completion (Actual): April 4, 2018

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 12-0344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared outside of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No