Improvement of Fitness in Obese Children

Pediatric Obesity Clinical Trial

Official title:

Improvement of Fitness and Health in Children With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483454
• Other study ID #: 00007398
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: August 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Other:
• Exercise class
Same as above.
• Home exercise
Same as above.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Pennsylvania American Academy of Pediatrics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change in sleep in obese children	measurement of amount of sleep measured in hours via Fitbit	8 weeks and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Amount of sleep in children	Amount of sleep will be measured in hours via Fitbit	daily for 6 months
Secondary	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
Secondary	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
Secondary	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