Clinical trial NCT03483454: Improvement of Fitness in Obese Children
Official title: Improvement of Fitness and Health in Children With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: exercise, fitness, sleep, children, obesity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Pennsylvania American Academy of Pediatrics
First posted: 2018-03-30
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The purpose of this study is to improve physical fitness and health parameters in elementary-aged children who participate in an academic weight loss clinic. Patients and their parents are randomly assigned to either take exercise classes or to continue standard care (control group). Exercise classes are run at a local church 3 times a week for 8 weeks and children and parents are expected to participate. Parents are expected to follow similar dietary and exercise recommendations which are given to their children. Vitals, lab work and fitness testing are done on children at beginning, middle and end of the 6- month study. Vitals are done on parents at the beginning, middle and end of the study. Children are given Fitbits to record sleep patterns and daily physical activity.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in amount of Fitness in Obese Children as measured by daily physical activity via Fitbit
timeFrame: 8 weeks and 6 months
measure: Program attendance by the child and parent in the exercise class arm
timeFrame: 8 weeks
measure: Change in intensity of daily activity in obese children
timeFrame: 8 weeks and 6 months
measure: Change in sleep in obese children
timeFrame: 8 weeks and 6 months
Secondary outcomes:
measure: Metabolic parameters of children with obesity: Body Mass Index (BMI)
timeFrame: 8 weeks and 6 months
measure: Metabolic parameters of children with obesity: blood pressure
timeFrame: 8 week and 6 months
measure: Metabolic parameters of children with obesity: resting heart rate
timeFrame: 8 weeks and 6 months
measure: Metabolic parameters of children with obesity: Blood glucose (sugar)
timeFrame: 8 weeks and 6 months
measure: Metabolic parameters of children with obesity: Cholesterol (Lipid Panel)
timeFrame: 8 weeks and 6 months
measure: Metabolic parameters of children with obesity: Insulin level
timeFrame: 8 weeks and 6 months
measure: Metabolic parameters of children with obesity: Hemoglobin A1c levels
timeFrame: 8 weeks and 6 months
measure: Metabolic parameters of children with obesity: Liver Function Tests (LFTs)
timeFrame: 8 weeks and 6 months
measure: Depression measurements in children with obesity
timeFrame: 8 weeks and 6 months
measure: Motivation of children with obesity and their parents
timeFrame: 8 weeks and 6 months
measure: Fitness Testing of children with obesity
timeFrame: 8 weeks and 6 months
measure: Amount of sleep in children
timeFrame: daily for 6 months
measure: Parental vital signs: blood pressure
timeFrame: 8 weeks and 6 months
measure: Parental vital signs: heart rate
timeFrame: 8 weeks and 6 months
measure: Parental vital signs: Body Mass Index (BMI)
timeFrame: 8 weeks and 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Marsha B Novick, MD
role: PRINCIPAL_INVESTIGATOR
References: