NCT07778433

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:

  • 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 17, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

basketballobesityoverweightPediatric obesityPediatric overweightChildhood obesityAdolescent obesitybody mass indexphysical activityexercisenutritionhealth behaviorslifestyle interventionBasketballRxmental healthanxietydepressioncommunity-based interventionhealth education

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Change in self-reported physical activity, nutrition, and sleep habits at 2months.

    2 months

  • Change in waist circumference at 2 months.

    2 months

  • Program attendance and completion rates.

    2 months

  • Change in anxiety and depression levels.

    2 months

Study Arms (1)

BasketballRx Intervention

EXPERIMENTAL

Participants 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.

Behavioral: BasketballRx

Interventions

BasketballRxBEHAVIORAL

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.

BasketballRx Intervention

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Camp Curtin Branch of the YMCA

Harrisburg, Pennsylvania, 17110, United States

Location

Penn State Health Medical Group Harrisburg

Harrisburg, Pennsylvania, 17110, United States

Location

Related Publications (12)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 27821267BACKGROUND
  • 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/

    PMID: 39475513BACKGROUND
  • 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.

    PMID: 11148895BACKGROUND
  • 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.

    PMID: 19130639BACKGROUND
  • 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.

    PMID: 9100430BACKGROUND
  • 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.

    PMID: 21807669BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityAnxiety DisordersPsychological Well-BeingObesityOverweightMotor ActivityHealth BehaviorDepressionHealth Education

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPersonal SatisfactionBehaviorBehavioral SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Officials

  • Sarah I Ramirez, MD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 21, 2026

Study Start

March 3, 2026

Primary Completion

August 29, 2026

Study Completion

August 29, 2026

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations