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Completed

NCT Number: NCT03656991

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.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bicycle intervention

Other

Primary outcomes

  1. Change in Body Mass Index

    Time frame: Change from Baseline BMI through study completion up to 78 weeks

  2. Change in Physical Activity

    Time frame: Change from Baseline Physical Activity through study completion up to 78 weeks

    Average time spent participating in physical activity

  3. Change in Sedentary Activity

    Time frame: Change from Baseline Sedentary Activity through study completion up to 78 weeks

    Average time spent in sedentary activities

Secondary outcomes

  1. Change in Consumption of sugary drinks

    Time frame: Change from Baseline Consumption of Sugary Drinks through study completion up to 78 weeks

    Number of sugary drinks consumed

  2. Change in Consumption of Fast Food

    Time frame: Change from Baseline Consumption of Fast Food through study completion up to 78 weeks

    Number of times fast food was consumed

  3. Change in Consumption of Fruits

    Time frame: Change from Baseline Consumption of Fruits through study completion up to 78 weeks

    Number of fruits consumed

  4. Change in Consumption of Vegetables

    Time frame: Change from Baseline Consumption of Vegetables through study completion up to 78 weeks

    Number of vegetables consumed

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Children's Hospital Colorado
  • UnitedHealthcare

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Sep 4, 2018
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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