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Improvement of Fitness in Obese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483454
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Pennsylvania American Academy of Pediatrics
Information provided by (Responsible Party):
Marsha Novick, Milton S. Hershey Medical Center

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

Condition or disease Intervention/treatment Phase
Pediatric Obesity Other: Exercise class Other: Home exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Fitness and Health in Children With Obesity
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in amount of Fitness in Obese Children as measured by daily physical activity via Fitbit [ Time Frame: 8 weeks and 6 months ]
    measurement of amount of daily physical activity (in minutes) hours) as measured by daily physical activity via Fitbit

  2. Program attendance by the child and parent in the exercise class arm [ Time Frame: 8 weeks ]
    Class attendance will be taken at each class that is held 3x/week for 8 weeks

  3. Change in intensity of daily activity in obese children [ Time Frame: 8 weeks and 6 months ]
    measurement of intensity of daily activity measured by minutes of elevated heart rate via Fitbit

  4. Change in sleep in obese children [ Time Frame: 8 weeks and 6 months ]
    measurement of amount of sleep measured in hours via Fitbit


Secondary Outcome Measures :
  1. Metabolic parameters of children with obesity: Body Mass Index (BMI) [ Time Frame: 8 weeks and 6 months ]
    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

  2. Metabolic parameters of children with obesity: blood pressure [ Time Frame: 8 week and 6 months ]
    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)

  3. Metabolic parameters of children with obesity: resting heart rate [ Time Frame: 8 weeks and 6 months ]
    Resting heart rate will be measured by nurses at the Pediatric Weight Management Clinic in beats per minute (BPM)

  4. Metabolic parameters of children with obesity: Blood glucose (sugar) [ Time Frame: 8 weeks and 6 months ]
    Lab work will be obtained to check fasting blood glucose in milligrams per deciliter (mg/dL)

  5. Metabolic parameters of children with obesity: Cholesterol (Lipid Panel) [ Time Frame: 8 weeks and 6 months ]
    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)

  6. Metabolic parameters of children with obesity: Insulin level [ Time Frame: 8 weeks and 6 months ]
    Lab work will be obtained to check fasting insulin level (in u International Units per milliliter)

  7. Metabolic parameters of children with obesity: Hemoglobin A1c levels [ Time Frame: 8 weeks and 6 months ]
    Lab work will be obtained to check hemoglobin A1c level (in percent of total hemoglobin)

  8. Metabolic parameters of children with obesity: Liver Function Tests (LFTs) [ Time Frame: 8 weeks and 6 months ]
    Lab work will be obtained to check liver function tests, including Aspartate Aminotransferase (in Units per liter) and Alanine Transaminase (in Units per liter)

  9. Depression measurements in children with obesity [ Time Frame: 8 weeks and 6 months ]
    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

  10. Motivation of children with obesity and their parents [ Time Frame: 8 weeks and 6 months ]
    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.

  11. Fitness Testing of children with obesity [ Time Frame: 8 weeks and 6 months ]
    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

  12. Amount of sleep in children [ Time Frame: daily for 6 months ]
    Amount of sleep will be measured in hours via Fitbit

  13. Parental vital signs: blood pressure [ Time Frame: 8 weeks and 6 months ]
    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)

  14. Parental vital signs: heart rate [ Time Frame: 8 weeks and 6 months ]
    Resting heart rate will be measured nurses at the Pediatric Weight Management Clinic in beats per minute (BPM)

  15. Parental vital signs: Body Mass Index (BMI) [ Time Frame: 8 weeks and 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483454


Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Pennsylvania American Academy of Pediatrics
Investigators
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Principal Investigator: Marsha B Novick, MD Milton S. Hershey Medical Center

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Responsible Party: Marsha Novick, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03483454    
Other Study ID Numbers: 00007398
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marsha Novick, Milton S. Hershey Medical Center:
exercise, fitness, sleep, children, obesity
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms