NCT05880901 Healthy Kids Beyond the Bell: Investigating the Impact of After-School and Summer Programs
| NCT ID | NCT05880901 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of South Carolina |
| Condition | Health Status Disparities |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 480 participants in total. It began in 2024-03-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Nearly one in five children are obese, and disparities in overweight and obesity between children from low- and middle-to-high-income households persist despite a multitude of school-based interventions. The structured days hypothesis posits that structure within a school day plays a protective role for children against obesogenic behaviors, and, ultimately, prevents the occurrence of excessive weight gain, thus, past school-based efforts are misplaced. This study will provide access to healthy structured programming via vouchers to afterschool programs and summer day camps during two "windows of vulnerability" (ie afterschool and summer) for low-income children.
Eligibility Criteria
Inclusion Criteria: * k-4th grader in a partner school * eligible for free and reduced price lunch (a widely recognized indicator of * socioeconomic level and poverty status) * parent that indicates "yes' on an informed consent document for participation in the study Exclusion Criteria: * Diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol * a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance. * Families who plan to enroll their children in a summer camp or after school program or relocate (i.e., move) during the 14-month period that they participate
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05880901 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Health Status Disparities. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05880901 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05880901 currently recruiting?
Yes, NCT05880901 is actively recruiting participants. Contact the research team at weaverrg@mailbox.sc.edu for enrollment information.
Where is the NCT05880901 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT05880901 clinical trial?
NCT05880901 is sponsored by University of South Carolina. The trial plans to enroll 480 participants.