Improvement of Fitness in Obese Children

NCT ID: NCT03483454

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise classes

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

Group Type EXPERIMENTAL

Exercise class

Intervention Type OTHER

Same as above.

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."

Group Type EXPERIMENTAL

Home exercise

Intervention Type OTHER

Same as above.

Interventions

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Exercise class

Same as above.

Intervention Type OTHER

Home exercise

Same as above.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennsylvania American Academy of Pediatrics

UNKNOWN

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marsha Novick

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marsha B Novick, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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00007398

Identifier Type: -

Identifier Source: org_study_id

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