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

NCT03656991 | Completed

• 1 other identifier: 12-0344
• Study Type: interventional
• Target: 525
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in Consumption of sugary drinks

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

• Change in Consumption of Fast Food

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

• Change in Consumption of Fruits

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

• Change in Consumption of Vegetables

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

Study Arms (4)

0 month group

EXPERIMENTAL

Receive the bicycle intervention at 0 months after enrollment.

Other: Bicycle intervention

2 month group

EXPERIMENTAL

Receive the bicycle intervention at 2 months after enrollment.

Other: Bicycle intervention

4 month group

EXPERIMENTAL

Receive the bicycle intervention at 4 months after enrollment.

Other: Bicycle intervention

6 month group

EXPERIMENTAL

Receive the bicycle intervention at 6 months after enrollment.

Other: Bicycle intervention

Interventions

Bicycle intervention OTHER

0 month group; 2 month group; 4 month group; 6 month group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 6-12 years
• Do not own a bicycle
• BMI over 85% for age (overweight or obese)

You may not qualify if:

• Outside of state age range
• Not overweight or obese
• Already own a bicycle.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator
• UnitedHealthcare: collaborator

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Maya Bunik, MD, MSPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 4, 2018
• Study Start: April 6, 2012
• Primary Completion: October 25, 2016
• Study Completion: April 4, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share