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Completed

NCT Number: NCT03483454

Improvement of Fitness in Obese Children

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

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Key information

Conditions

Pediatric Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise class

Other

Same as above.

Home exercise

Other

Same as above.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Pennsylvania American Academy of Pediatrics

Registry information

Official study title

Improvement of Fitness and Health in Children With Obesity

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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