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Pediatric ObesityNCT03483454

Improvement of Fitness in Obese Children

A study testing Exercise class and Home exercise in people with Pediatric Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric Obesity
What is being tested?
Exercise class and Home exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
1 Dec 2017to 1 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: 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.

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.

Being tested
Exercise class, Home exercise
Keywords
exercise, fitness, sleep, children, obesity
Medical subject headings
Pediatric Obesity, Motor Activity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise classOther

    Same as above.

  • Home exerciseOther

    Same as above.

Study groups in NCT03483454
Study groupRoleWhat they receive
Exercise classesExperimentalThis group of children and their parents will participate in an exercise class for 8 weeks.
Receives: Other: Exercise class
Home exerciseExperimentalThis 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."
Receives: Other: Home exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 8 weeks and 6 months

  4. Change in sleep in obese children

    measurement of amount of sleep measured in hours via Fitbit

    Measured: 8 weeks and 6 months

Secondary outcomes (15)

  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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 8 weeks and 6 months

  12. Amount of sleep in children

    Amount of sleep will be measured in hours via Fitbit

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 8 weeks and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study start1 Dec 2017
  3. Primary completion1 Jun 2018
  4. Study completion1 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03483454
Sponsor's protocol ID
00007398
Status last verified
Aug 2018
First submitted
8 Feb 2018
Last updated
17 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise class and Home exercise in people with Pediatric Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in amount of Fitness in Obese Children as measured by daily physical activity via Fitbit (time frame: 8 weeks and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03483454.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.

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