Improvement of Fitness in Obese Children
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise class
Home exercise
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring exercise, fitness, sleep, children, obesity
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
Sites / Locations
- Penn State Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Exercise classes
Home exercise
Arm Description
This group of children and their parents will participate in an exercise class for 8 weeks.
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."
Outcomes
Primary Outcome Measures
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
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
Change in intensity of daily activity in obese children
measurement of intensity of daily activity measured by minutes of elevated heart rate via Fitbit
Change in sleep in obese children
measurement of amount of sleep measured in hours via Fitbit
Secondary Outcome Measures
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
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)
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)
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)
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)
Metabolic parameters of children with obesity: Insulin level
Lab work will be obtained to check fasting insulin level (in u International Units per milliliter)
Metabolic parameters of children with obesity: Hemoglobin A1c levels
Lab work will be obtained to check hemoglobin A1c level (in percent of total hemoglobin)
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)
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
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.
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
Amount of sleep in children
Amount of sleep will be measured in hours via Fitbit
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)
Parental vital signs: heart rate
Resting heart rate will be measured nurses at the Pediatric Weight Management Clinic in beats per minute (BPM)
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
Full Information
NCT ID
NCT03483454
First Posted
February 8, 2018
Last Updated
August 16, 2018
Sponsor
Milton S. Hershey Medical Center
Collaborators
Pennsylvania American Academy of Pediatrics
1. Study Identification
Unique Protocol Identification Number
NCT03483454
Brief Title
Improvement of Fitness in Obese Children
Official Title
Improvement of Fitness and Health in Children With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Pennsylvania American Academy of Pediatrics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
exercise, fitness, sleep, children, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise classes
Arm Type
Experimental
Arm Description
This group of children and their parents will participate in an exercise class for 8 weeks.
Arm Title
Home exercise
Arm Type
Experimental
Arm Description
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."
Intervention Type
Other
Intervention Name(s)
Exercise class
Intervention Description
Same as above.
Intervention Type
Other
Intervention Name(s)
Home exercise
Intervention Description
Same as above.
Primary Outcome Measure Information:
Title
Change in amount of Fitness in Obese Children as measured by daily physical activity via Fitbit
Description
measurement of amount of daily physical activity (in minutes) hours) as measured by daily physical activity via Fitbit
Time Frame
8 weeks and 6 months
Title
Program attendance by the child and parent in the exercise class arm
Description
Class attendance will be taken at each class that is held 3x/week for 8 weeks
Time Frame
8 weeks
Title
Change in intensity of daily activity in obese children
Description
measurement of intensity of daily activity measured by minutes of elevated heart rate via Fitbit
Time Frame
8 weeks and 6 months
Title
Change in sleep in obese children
Description
measurement of amount of sleep measured in hours via Fitbit
Time Frame
8 weeks and 6 months
Secondary Outcome Measure Information:
Title
Metabolic parameters of children with obesity: Body Mass Index (BMI)
Description
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
Time Frame
8 weeks and 6 months
Title
Metabolic parameters of children with obesity: blood pressure
Description
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)
Time Frame
8 week and 6 months
Title
Metabolic parameters of children with obesity: resting heart rate
Description
Resting heart rate will be measured by nurses at the Pediatric Weight Management Clinic in beats per minute (BPM)
Time Frame
8 weeks and 6 months
Title
Metabolic parameters of children with obesity: Blood glucose (sugar)
Description
Lab work will be obtained to check fasting blood glucose in milligrams per deciliter (mg/dL)
Time Frame
8 weeks and 6 months
Title
Metabolic parameters of children with obesity: Cholesterol (Lipid Panel)
Description
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)
Time Frame
8 weeks and 6 months
Title
Metabolic parameters of children with obesity: Insulin level
Description
Lab work will be obtained to check fasting insulin level (in u International Units per milliliter)
Time Frame
8 weeks and 6 months
Title
Metabolic parameters of children with obesity: Hemoglobin A1c levels
Description
Lab work will be obtained to check hemoglobin A1c level (in percent of total hemoglobin)
Time Frame
8 weeks and 6 months
Title
Metabolic parameters of children with obesity: Liver Function Tests (LFTs)
Description
Lab work will be obtained to check liver function tests, including Aspartate Aminotransferase (in Units per liter) and Alanine Transaminase (in Units per liter)
Time Frame
8 weeks and 6 months
Title
Depression measurements in children with obesity
Description
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
Time Frame
8 weeks and 6 months
Title
Motivation of children with obesity and their parents
Description
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.
Time Frame
8 weeks and 6 months
Title
Fitness Testing of children with obesity
Description
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
Time Frame
8 weeks and 6 months
Title
Amount of sleep in children
Description
Amount of sleep will be measured in hours via Fitbit
Time Frame
daily for 6 months
Title
Parental vital signs: blood pressure
Description
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)
Time Frame
8 weeks and 6 months
Title
Parental vital signs: heart rate
Description
Resting heart rate will be measured nurses at the Pediatric Weight Management Clinic in beats per minute (BPM)
Time Frame
8 weeks and 6 months
Title
Parental vital signs: Body Mass Index (BMI)
Description
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
Time Frame
8 weeks and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marsha B Novick, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Improvement of Fitness in Obese Children
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