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

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bicycle intervention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    0 month group

    2 month group

    4 month group

    6 month group

    Arm Description

    Receive the bicycle intervention at 0 months after enrollment.

    Receive the bicycle intervention at 2 months after enrollment.

    Receive the bicycle intervention at 4 months after enrollment.

    Receive the bicycle intervention at 6 months after enrollment.

    Outcomes

    Primary Outcome Measures

    Change in Body Mass Index
    Change in Physical Activity
    Average time spent participating in physical activity
    Change in Sedentary Activity
    Average time spent in sedentary activities

    Secondary Outcome Measures

    Change in Consumption of sugary drinks
    Number of sugary drinks consumed
    Change in Consumption of Fast Food
    Number of times fast food was consumed
    Change in Consumption of Fruits
    Number of fruits consumed
    Change in Consumption of Vegetables
    Number of vegetables consumed

    Full Information

    First Posted
    August 23, 2018
    Last Updated
    August 30, 2018
    Sponsor
    University of Colorado, Denver
    Collaborators
    Children's Hospital Colorado, UnitedHealthcare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03656991
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 6, 2012 (Actual)
    Primary Completion Date
    October 25, 2016 (Actual)
    Study Completion Date
    April 4, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    Children's Hospital Colorado, UnitedHealthcare

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    525 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0 month group
    Arm Type
    Experimental
    Arm Description
    Receive the bicycle intervention at 0 months after enrollment.
    Arm Title
    2 month group
    Arm Type
    Experimental
    Arm Description
    Receive the bicycle intervention at 2 months after enrollment.
    Arm Title
    4 month group
    Arm Type
    Experimental
    Arm Description
    Receive the bicycle intervention at 4 months after enrollment.
    Arm Title
    6 month group
    Arm Type
    Experimental
    Arm Description
    Receive the bicycle intervention at 6 months after enrollment.
    Intervention Type
    Other
    Intervention Name(s)
    Bicycle intervention
    Primary Outcome Measure Information:
    Title
    Change in Body Mass Index
    Time Frame
    Change from Baseline BMI through study completion up to 78 weeks
    Title
    Change in Physical Activity
    Description
    Average time spent participating in physical activity
    Time Frame
    Change from Baseline Physical Activity through study completion up to 78 weeks
    Title
    Change in Sedentary Activity
    Description
    Average time spent in sedentary activities
    Time Frame
    Change from Baseline Sedentary Activity through study completion up to 78 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Consumption of sugary drinks
    Description
    Number of sugary drinks consumed
    Time Frame
    Change from Baseline Consumption of Sugary Drinks through study completion up to 78 weeks
    Title
    Change in Consumption of Fast Food
    Description
    Number of times fast food was consumed
    Time Frame
    Change from Baseline Consumption of Fast Food through study completion up to 78 weeks
    Title
    Change in Consumption of Fruits
    Description
    Number of fruits consumed
    Time Frame
    Change from Baseline Consumption of Fruits through study completion up to 78 weeks
    Title
    Change in Consumption of Vegetables
    Description
    Number of vegetables consumed
    Time Frame
    Change from Baseline Consumption of Vegetables through study completion up to 78 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maya Bunik, MD, MSPH
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared outside of the study.

    Learn more about this trial

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

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