Pediatric Obesity
Conditions
Keywords
exercise, fitness, sleep, children, obesity
Brief summary
This study observes fitness level and health parameters in children ages 6-12 years old with obesity using an exercise class intervention.
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.
Interventions
OTHERExercise class
Same as above.
OTHERHome exercise
Same as above.
Sponsors
Pennsylvania American Academy of Pediatrics
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in amount of Fitness in Obese Children as measured by daily physical activity via Fitbit | 8 weeks and 6 months | measurement of amount of daily physical activity (in minutes) hours) as measured by daily physical activity via Fitbit |
| Program attendance by the child and parent in the exercise class arm | 8 weeks | Class attendance will be taken at each class that is held 3x/week for 8 weeks |
| Change in intensity of daily activity in obese children | 8 weeks and 6 months | measurement of intensity of daily activity measured by minutes of elevated heart rate via Fitbit |
| Change in sleep in obese children | 8 weeks and 6 months | measurement of amount of sleep measured in hours via Fitbit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic parameters of children with obesity: Cholesterol (Lipid Panel) | 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) |
| Metabolic parameters of children with obesity: Insulin level | 8 weeks and 6 months | Lab work will be obtained to check fasting insulin level (in u International Units per milliliter) |
| Metabolic parameters of children with obesity: Hemoglobin A1c levels | 8 weeks and 6 months | Lab work will be obtained to check hemoglobin A1c level (in percent of total hemoglobin) |
| Metabolic parameters of children with obesity: Liver Function Tests (LFTs) | 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) |
| Depression measurements in children with obesity | 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 |
| Metabolic parameters of children with obesity: Body Mass Index (BMI) | 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 |
| Fitness Testing of children with obesity | 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 |
| Amount of sleep in children | daily for 6 months | Amount of sleep will be measured in hours via Fitbit |
| Parental vital signs: blood pressure | 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) |
| Parental vital signs: heart rate | 8 weeks and 6 months | Resting heart rate will be measured nurses at the Pediatric Weight Management Clinic in beats per minute (BPM) |
| Parental vital signs: Body Mass Index (BMI) | 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 |
| Motivation of children with obesity and their parents | 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. |
| Metabolic parameters of children with obesity: blood pressure | 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) |
| Metabolic parameters of children with obesity: resting heart rate | 8 weeks and 6 months | Resting heart rate will be measured by nurses at the Pediatric Weight Management Clinic in beats per minute (BPM) |
| Metabolic parameters of children with obesity: Blood glucose (sugar) | 8 weeks and 6 months | Lab work will be obtained to check fasting blood glucose in milligrams per deciliter (mg/dL) |
Countries
United States
Outcome results
None listed