Improvement of Fitness in Obese Children

Improvement of Fitness and Health in Children With Obesity

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

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Other: Exercise class; Other: Home exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise classes; This group of children and their parents will participate in an exercise class for 8 weeks.	Other: Exercise class; Same as above.
EXPERIMENTAL: Home exercise; 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; Same as above.

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Pennsylvania American Academy of Pediatrics
• Investigators: Principal Investigator: Marsha B Novick, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (ACTUAL): March 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: exercise, fitness, sleep, children, obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 00007398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No