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Pediatric ObesityNCT07778433

BasketballRx: Game Changing Health

A study testing BasketballRx in people with Pediatric Obesity and Pediatric Overweight, run by Milton S. Hershey Medical Center at 2 sites 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

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. Read more about this study

Who is it for?
Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric Obesity, Pediatric Overweight, Anxiety
What is being tested?
BasketballRx
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesUnited States
Study dates
3 Mar 2026to 29 Aug 2026
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 10 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Camp Curtin Branch of the YMCA

    Harrisburg, Pennsylvania, 17110

  • Penn State Health Medical Group Harrisburg

    Harrisburg, Pennsylvania, 17110

Other trials in United States

About this study

Official title: BasketballRx: Game Changing Health - Combating Adolescent Obesity and Mental Health With Hoops and Health

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:

Read more
  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
Read the 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.

Being tested
BasketballRx
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
Medical subject headings
Pediatric Obesity, Anxiety Disorders, Psychological Well-Being, Obesity, Overweight, Motor Activity, Health Behavior, Depression

What participants receive

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

  • BasketballRxBehavioural

    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.

Study groups in NCT07778433
Study groupRoleWhat they receive
BasketballRx InterventionExperimentalParticipants will receive the BasketballRx intervention, a community-based health and wellness program that combines health education with structured basketball activities. Participants will attend six sessions over approximately two months. Sessions 1 through 5 will each last 90 minutes and include 40 minutes of interactive health education and 50 minutes of age-appropriate basketball activities. Health topics will include nutrition, hydration, reading food labels, healthy eating, sleep, injury prevention, mindfulness, and stress management. Basketball activities will include warm-ups, skill-building drills, games, and team activities designed to promote physical activity and teamwork. Session 6 will be a three-hour "Hoops for Health Fair." Participants will take part in basketball games and skill activities and share what they learned about healthy living with family and community members.
Receives: Behavioral: BasketballRx

What is being measured

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

  1. Change from baseline in the BMI at 2 months

    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.

    Measured: Baseline and approximately 2 months after completion of the BasketballRx intervention.

Secondary outcomes (4)
  1. Change in self-reported physical activity, nutrition, and sleep habits at 2months.

    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.

    Measured: 2 months

  2. Change in waist circumference at 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.

    Measured: 2 months

  3. Program attendance and completion rates.

    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.

    Measured: 2 months

  4. Change in anxiety and depression levels.

    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.

    Measured: 2 months

Timeline

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

  1. First posted21 Aug 2026
  2. Study start3 Mar 2026
  3. Primary completion29 Aug 2026
  4. Study completion29 Aug 2026

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07778433
Sponsor's protocol ID
27448
Status last verified
Sep 2026
First submitted
17 Aug 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because this is a small pilot study involving minors and includes potentially sensitive health information. Given the small sample size, there is an increased risk of participant re-identification even after direct identifiers are removed.

Publications

  • American College of Sports Medicine. (n.d.). Physical activity guidelines for children. Retrieved August 22, 2025, from https://www.acsm.org/physical-activity-guidelines-children

  • Centers for Disease Control and Prevention. (2024, June). Physical activity guidelines for Americans, 2nd edition. U.S. Department of Health & Human Services. https://www.cdc.gov/physical-activity-education/guidelines/index.html

  • US Preventive Services Task Force; Mangione CM, Barry MJ, Nicholson WK, Cabana M, Coker TR, Davidson KW, Davis EM, Donahue KE, Jaen CR, Kubik M, Li L, Ogedegbe G, Pbert L, Ruiz JM, Silverstein M, Stevermer J, Wong JB. Screening for Anxiety in Children and Adolescents: US Preventive Services Task Force Recommendation Statement. JAMA. 2022 Oct 11;328(14):1438-1444. doi: 10.1001/jama.2022.16936.

    PubMed 36219403
  • Pennsylvania Health Policy Coalition. (2020). Obesity. Accessed February 12, 2025. https://pahealthpolicy.org/obesity

  • Office of the Surgeon General. (2021). Protecting youth mental health: The U.S. Surgeon General's advisory. U.S. Department of Health and Human Services. Accessed July 17, 2025. https://www.hhs.gov/sites/default/files/surgeon-general-youth-mental-health-advisory.pdf

  • National Center for Health Statistics. (2021). Prevalence of obesity among children and adolescents aged 2-19 years: United States, 2017-2020 (National Health Statistics Reports No. 158). https://www.cdc.gov/nchs/data/nhsr/nhsr158-508.pdf

  • Werner-Seidler A, Perry Y, Calear AL, Newby JM, Christensen H. School-based depression and anxiety prevention programs for young people: A systematic review and meta-analysis. Clin Psychol Rev. 2017 Feb;51:30-47. doi: 10.1016/j.cpr.2016.10.005. Epub 2016 Oct 24.

    PubMed 27821267
  • Sappenfield O, Alberto C, Minnaert J, Donney J, Lebrun-Harris L, Ghandour R. Adolescent Mental and Behavioral Health, 2023. 2024 Oct. In: National Survey of Children's Health Data Briefs [Internet]. Rockville (MD): Health Resources and Services Administration; 2018-. Available from http://www.ncbi.nlm.nih.gov/books/NBK608531/

    PubMed 39475513
  • Salmon P. Effects of physical exercise on anxiety, depression, and sensitivity to stress: a unifying theory. Clin Psychol Rev. 2001 Feb;21(1):33-61. doi: 10.1016/s0272-7358(99)00032-x.

    PubMed 11148895
  • McGuigan MR, Tatasciore M, Newton RU, Pettigrew S. Eight weeks of resistance training can significantly alter body composition in children who are overweight or obese. J Strength Cond Res. 2009 Jan;23(1):80-5. doi: 10.1519/jsc.0b013e3181876a56.

    PubMed 19130639
  • Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):545-53. doi: 10.1097/00004583-199704000-00018.

    PubMed 9100430
  • Biddle SJ, Asare M. Physical activity and mental health in children and adolescents: a review of reviews. Br J Sports Med. 2011 Sep;45(11):886-95. doi: 10.1136/bjsports-2011-090185. Epub 2011 Aug 1.

    PubMed 21807669

Questions about this trial

What is this clinical trial studying?

A study testing BasketballRx in people with Pediatric Obesity and Pediatric Overweight, run by Milton S. Hershey Medical Center at 2 sites 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 7 inclusion and 14 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 from baseline in the BMI at 2 months (time frame: Baseline and approximately 2 months after completion of the BasketballRx intervention.). 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 NCT07778433, which also lists 12 linked publications.

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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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