Improvement of Fitness in Obese Children

Study Overview
=================
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.

Official Title
-----------------
Improvement of Fitness and Health in Children With Obesity

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Other: Exercise class
* Other: Home exercise


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise classes<br>This group of children and their parents will participate in an exercise class for 8 weeks. | Other: Exercise class<br>* Same as above.<br>|
| Experimental: Home exercise<br>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<br>* Same as above.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic parameters of children with obesity: Body Mass Index (BMI) | Height (in centimeters) and weight (in kilograms) will be measured by nurses at the Pediatric Weight Management Clinic. Height and weight will be combined to report Body Mass Index (BMI) in kg/m2 | 8 weeks and 6 months | 
| Metabolic parameters of children with obesity: blood pressure | Blood pressure will be measured by nurses at the Pediatric Weight Management Clinic and reported as systolic blood pressure over diastolic blood pressure measured in millimeter of mercury (mmHg) | 8 week and 6 months | 
| Metabolic parameters of children with obesity: resting heart rate | Resting heart rate will be measured by nurses at the Pediatric Weight Management Clinic in beats per minute (BPM) | 8 weeks and 6 months | 
| Metabolic parameters of children with obesity: Blood glucose (sugar) | Lab work will be obtained to check fasting blood glucose in milligrams per deciliter (mg/dL) | 8 weeks and 6 months | 
| Metabolic parameters of children with obesity: Cholesterol (Lipid Panel) | Lab work will be obtained to check a fasting lipid panel, which includes total cholesterol (in milligrams per deciliter), LDL cholesterol (in milligrams per deciliter), HDL cholesterol (in milligrams per deciliter) and triglycerides (in milligrams per deciliter) | 8 weeks and 6 months | 
| Metabolic parameters of children with obesity: Insulin level | Lab work will be obtained to check fasting insulin level (in u International Units per milliliter) | 8 weeks and 6 months | 
| Metabolic parameters of children with obesity: Hemoglobin A1c levels | Lab work will be obtained to check hemoglobin A1c level (in percent of total hemoglobin) | 8 weeks and 6 months | 
| Metabolic parameters of children with obesity: Liver Function Tests (LFTs) | Lab work will be obtained to check liver function tests, including Aspartate Aminotransferase (in Units per liter) and Alanine Transaminase (in Units per liter) | 8 weeks and 6 months | 
| Depression measurements in children with obesity | The Center for Epidemiologic Studies Depression Scale (CES-DC) will be used to measure depressive symptoms in children. The scale ranges from 0-60; higher scores suggest greater prevalence of depressive symptoms | 8 weeks and 6 months | 
| Motivation of children with obesity and their parents | A survey will be distributed to the children and their parents at the beginning of their participation of the study, at the end of the 8-week exercise class period, and 6 months after enrollment. The survey will explore physical activity history and goals. | 8 weeks and 6 months | 
| Fitness Testing of children with obesity | All children in the study will be asked to complete a 6-minute fitness walking test (measured in feet) prior to the start of the study, at the end of the 8-week exercise class period, and 6 months after enrollment | 8 weeks and 6 months | 
| Amount of sleep in children | Amount of sleep will be measured in hours via Fitbit | daily for 6 months | 
| Parental vital signs: blood pressure | Blood pressure will be measured by nurses at the Pediatric Weight Management Clinic and reported as systolic blood pressure over diastolic blood pressure measured in millimeter of mercury (mmHg) | 8 weeks and 6 months | 
| Parental vital signs: heart rate | Resting heart rate will be measured nurses at the Pediatric Weight Management Clinic in beats per minute (BPM) | 8 weeks and 6 months | 
| Parental vital signs: Body Mass Index (BMI) | Height (in centimeters) and weight (in kilograms) will be measured by nurses at the Pediatric Weight Management Clinic. Height and weight will be combined to report Body Mass Index (BMI) in kg/m2 | 8 weeks and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, fitness, sleep, children, obesity