ClinicalTrials.gg
CompletedNCT03483454Updated Aug 17, 2018

Improvement of Fitness in Obese Children

An interventional study of Exercise class and Home exercise in Pediatric Obesity, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 558 studies in Pediatric Obesity with a site in United States — 76 open to participants now, 111 under way, 3 of them phase 3. Pediatric Obesity · United States.

Enrollment
400th of 475
26 · median 95
Started
2017
with 45 others
No phase
422 of 558
53 open now
Registered
258th of 558
by date

Among the 558 studies in Pediatric Obesity with a site in United States, this one is the 400th largest by enrollment of the 475 interventional ones that give a count, is one of 46 that started in 2017, is one of 422 with no phase, and was the 258th registered.

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

Browse Pediatric Obesity studies →

Open to participants now

76 of the 558 studies in Pediatric Obesity with a site in United States are open now. Recruiting first, the newest first:

71 more — sign in →

All 76 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.

This study: 6 Years to 12 Years · all sexes · healthy volunteers too.

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02

Study summary

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

Read the 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.

03

Conditions studied

  • Pediatric Obesity

Keywords

  • exercise, fitness, sleep, children, obesity
04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Lack of transportation to exercise classes
  • Parents do not agree to participate in the exercise classes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Exercise classes

    This group of children and their parents will participate in an exercise class for 8 weeks.

    Other: Exercise class

  • 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

Interventions

  • OtherExercise class

    Same as above.

  • OtherHome exercise

    Same as above.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 weeks and 6 months

  2. 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

    Time frame: 8 weeks

  3. Change in intensity of daily activity in obese children

    measurement of intensity of daily activity measured by minutes of elevated heart rate via Fitbit

    Time frame: 8 weeks and 6 months

  4. Change in sleep in obese children

    measurement of amount of sleep measured in hours via Fitbit

    Time frame: 8 weeks and 6 months

Secondary outcomes

  1. 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

    Time frame: 8 weeks and 6 months

  2. 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)

    Time frame: 8 week and 6 months

  3. 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)

    Time frame: 8 weeks and 6 months

  4. 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)

    Time frame: 8 weeks and 6 months

  5. 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)

    Time frame: 8 weeks and 6 months

  6. Metabolic parameters of children with obesity: Insulin level

    Lab work will be obtained to check fasting insulin level (in u International Units per milliliter)

    Time frame: 8 weeks and 6 months

  7. Metabolic parameters of children with obesity: Hemoglobin A1c levels

    Lab work will be obtained to check hemoglobin A1c level (in percent of total hemoglobin)

    Time frame: 8 weeks and 6 months

  8. 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)

    Time frame: 8 weeks and 6 months

  9. 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

    Time frame: 8 weeks and 6 months

  10. 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.

    Time frame: 8 weeks and 6 months

  11. 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

    Time frame: 8 weeks and 6 months

  12. Amount of sleep in children

    Amount of sleep will be measured in hours via Fitbit

    Time frame: daily for 6 months

  13. 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)

    Time frame: 8 weeks and 6 months

  14. Parental vital signs: heart rate

    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

  15. 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

    Time frame: 8 weeks and 6 months

07

Study locations

1 site
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Jun 2018, 6 months.

Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 6 months is below that.

Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2018
First posted
Mar 30, 2018
StartActual
Dec 1, 2017
Primary completionActual
Jun 1, 2018
CompletionActual
Jun 1, 2018
Last update
Aug 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03483454
Collaborators
Pennsylvania American Academy of Pediatrics
Responsible party
Marsha Novick (Associate Professor, Milton S. Hershey Medical Center) — Principal investigator
First posted
Mar 30, 2018
Start date
Dec 1, 2017
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Aug 17, 2018

Study contacts

Marsha B Novick, MD
principal investigator · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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