Improvement of Fitness in Obese Children

NCT03483454 | Completed

• 1 other identifier: 00007398
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study observes fitness level and health parameters in children ages 6-12 years old with obesity using an exercise class intervention.

Conditions

Pediatric Obesity

Keywords

exercise, fitness, sleep, children, obesity

Outcome Measures

Primary Outcomes (4)

• Change in amount of Fitness in Obese Children as measured by daily physical activity via Fitbit

  measurement of amount of daily physical activity (in minutes) hours) as measured by daily physical activity via Fitbit

  8 weeks and 6 months

• Program attendance by the child and parent in the exercise class arm

  Class attendance will be taken at each class that is held 3x/week for 8 weeks

  8 weeks

• Change in intensity of daily activity in obese children

  measurement of intensity of daily activity measured by minutes of elevated heart rate via Fitbit

  8 weeks and 6 months

• Change in sleep in obese children

  measurement of amount of sleep measured in hours via Fitbit

  8 weeks and 6 months

Secondary Outcomes (15)

• Metabolic parameters of children with obesity: Body Mass Index (BMI)

  8 weeks and 6 months

• Metabolic parameters of children with obesity: blood pressure

  8 week and 6 months

• Metabolic parameters of children with obesity: resting heart rate

  8 weeks and 6 months

• Metabolic parameters of children with obesity: Blood glucose (sugar)

  8 weeks and 6 months

• Metabolic parameters of children with obesity: Cholesterol (Lipid Panel)

  8 weeks and 6 months

Study Arms (2)

Exercise classes

EXPERIMENTAL

This group of children and their parents will participate in an exercise class for 8 weeks.

Other: Exercise class

Home exercise

EXPERIMENTAL

This group of children and their parents will participate in exercise at home for 8 weeks. This is currently the standard of care in the weight management clinic (advise to continue increasing activity at home). This group is considered the "control group."

Other: Home exercise

Interventions

Exercise class OTHER

Same as above.

Exercise classes

Home exercise OTHER

Same as above.

Home exercise

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child must be a patient at the Penn State Hershey Children's Hospital Pediatric Multidisciplinary Weight Loss Program
• Child must be ages 6-12 years old

You may not qualify if:

• Lack of transportation to exercise classes
• Parents do not agree to participate in the exercise classes

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Pennsylvania American Academy of Pediatrics: collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Marsha B Novick, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: March 30, 2018
• Study Start: December 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)