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

NCT ID: NCT03656991

Last Updated: 2018-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-06

Study Completion Date

2018-04-04

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0 month group

Receive the bicycle intervention at 0 months after enrollment.

Group Type EXPERIMENTAL

Bicycle intervention

Intervention Type OTHER

2 month group

Receive the bicycle intervention at 2 months after enrollment.

Group Type EXPERIMENTAL

Bicycle intervention

Intervention Type OTHER

4 month group

Receive the bicycle intervention at 4 months after enrollment.

Group Type EXPERIMENTAL

Bicycle intervention

Intervention Type OTHER

6 month group

Receive the bicycle intervention at 6 months after enrollment.

Group Type EXPERIMENTAL

Bicycle intervention

Intervention Type OTHER

Interventions

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Bicycle intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Colorado

OTHER

Sponsor Role collaborator

UnitedHealthcare

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maya Bunik, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

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12-0344

Identifier Type: -

Identifier Source: org_study_id

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