Adolescent Obesity, Anxiety, Childhood Obesity, Childhood Overweight, Depression Disorders, Mental Health, Pediatric Obesity, Pediatric Overweight
Conditions
Keywords
basketball, obesity, overweight, Pediatric obesity, Pediatric overweight, Childhood obesity, Adolescent obesity, body mass index, physical activity, exercise, nutrition, health behaviors, lifestyle intervention, BasketballRx, mental health, anxiety, depression, community-based intervention, health education
Brief summary
The goal of this study is to learn if BasketballRx, a basketball and health program, works well for children and teens who are overweight or have obesity. The study will also look at whether the program helps children build healthy habits, improve their health, and feel better. The main questions the BasketballRx clinical trial aims to answer are: 1. Is the BasketballRx program easy for children and families to take part in and complete? 2. Do children show changes in their healthy habits, physical health, or emotional well-being after completing the program? Participants will: * Attend 6 BasketballRx sessions over 2 months * Take part in health lessons and basketball activities * Learn about healthy eating, exercise, sleep, and ways to manage stress * Have their height, weight, waist size, blood pressure, and heart rate checked * Answer questions about how they feel and their healthy habits
Detailed description
BasketballRx is a pilot study for children ages 10 to 15 who are overweight or have obesity. The study will help researchers learn if the program works well for children and families and if it may help children build healthier habits, improve their physical health, and support their emotional well-being. Up to 30 children will take part. Children will attend six BasketballRx sessions over about two months. The first five sessions will last 90 minutes. Each session will include a health lesson and basketball activities. Children will learn about healthy eating, drinking enough water, reading food labels, sleep, injury prevention, mindfulness, and ways to manage stress. They will also take part in basketball drills, games, and team activities designed for their age and skill level. The last session will be a three-hour "Hoops for Health Fair." Children will take part in basketball games and activities and share some of what they learned during the program with their families and community members. Researchers will look at how well the program works for children and families. They will track how many children join the study, attend the sessions, and complete the program. Children will also be asked what they thought about BasketballRx. Researchers will also look for changes in children's health and healthy habits. Height, weight, and waist size will be measured at the beginning and end of the program. Blood pressure and heart rate will be checked before physical activity at each session. Children will answer questions about healthy eating, physical activity, sleep, screen time, stress, mood, and other health habits. They will also complete standard questionnaires about feelings of anxiety and depression. If a child's answers show that they may need more support, the study team will follow the study safety plan and may recommend follow-up with the child's regular healthcare provider. Because this is a small pilot study, the main goal is to learn whether BasketballRx is practical and works well for children and families. Researchers will also look for early signs that the program may help improve healthy habits, physical health, and emotional well-being. What is learned from this study may be used to improve BasketballRx and plan larger studies in the future.
Interventions
BEHAVIORALBasketballRx
BasketballRx is a youth health and wellness program that combines interactive health education with structured basketball activities. The program teaches healthy habits related to nutrition, hydration, sleep, physical activity, mindfulness, and stress management while providing age-appropriate basketball activities that promote physical activity and teamwork. Participants complete six sessions over approximately two months.
Sponsors
Milton S. Hershey Medical Center
Highmark Blue Cross Blue Shield
Penn State Health
Aetna, Inc.
Harrisburg Area YMCA - Camp Curtin Branch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 10 years old to 15 years old. * BMI 85th percentile or higher * Patient at the Penn State Health Family and Community Medicine Clinic in Harrisburg, PA * Race/ethnicity self-reported as Black or Latino * One guardian (as listed in the EHR) must be present during the entirety of all sessions * English-speaking * Allowable medical conditions: depression, anxiety, adhd, hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, insulin resistance, prediabetes, diabetes, skin conditions, stage 1 hypertension.
Exclusion criteria
* Children younger than 10 years old or older than 15 years old * Children with a BMI lower than the 85th percentile * Children with structural cardiac conditions, respiratory conditions, concussion within the past 30days, Stage 2 hypertension, history of syncope or near syncope, cardiac dysrhythmias/channelopathies (e.g., long QT syndrome, heart block), history of exercise-induced chest pain or heart palpitations, family history of sudden cardiac death in children, seizure disorder, pregnancy. * Children with current or past orthopedic conditions/injuries. * Children with health conditions/physical limitations that render them unable to participate in any component of the program including but not limited to severe developmental delays, autism, wheelchair dependence. * Not cared for at the Penn State Health Family and Community Medicine Clinic in Harrisburg, PA * Not of Black/Latino race/ethnicity * Unaccompanied children * Inability to verify guardianship with the EHR * Non-English speaking * Participants without sneakers * Already enrolled in another formal exercise program * An elevated heart rate or newly discovered elevated blood pressure before the start of any of the sessions * Parent/guardian is unwilling or unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the BMI at 2 months | Baseline and approximately 2 months after completion of the BasketballRx intervention. | BMI will be calculated from measured height and weight and expressed in kg/m². BMI will be assessed at baseline (prior to the BasketballRx intervention) and at approximately 2 months after completion of the intervention. Change in BMI will be calculated as the post-intervention BMI minus the baseline BMI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported physical activity, nutrition, and sleep habits at 2months. | 2 months | Participants will complete a survey at baseline and at the end of the BasketballRx intervention to assess physical activity, nutrition, and sleep habits. Changes in self-reported health behaviors will be assessed by comparing responses before and after the BasketballRx intervention. |
| Change in waist circumference at 2 months. | 2 months | Waist circumference will be measured in centimeters at baseline and at approximately 2 months. Change in waist circumference will be calculated as the difference between the baseline and post-intervention measurements. |
| Program attendance and completion rates. | 2 months | Program attendance will be measured as the number and percentage of BasketballRx sessions attended by each participant. Program completion will be measured as the number and percentage of participants who meet the study-defined criteria for completing the BasketballRx program. |
| Change in anxiety and depression levels. | 2 months | Anxiety and depression symptoms will be assessed at baseline and at completion of the BasketballRx intervention. Anxiety symptoms will be measured using the Screen for Child Anxiety Related Disorders (SCARED), and depression symptoms will be measured using the Patient Health Questionnaire-2 (PHQ-2). Participants with a PHQ-2 score of 3 or greater will complete the Patient Health Questionnaire-Adolescent (PHQ-A) for further assessment. Changes in anxiety and depression scores will be assessed by comparing baseline and post-intervention scores. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah I Ramirez, MD
Penn State College of Medicine
Outcome results
None listed