NCT07583459 Efficacy of Center-based Childcare to Mitigate Unhealthy Weight Gain in Preschoolers From Low-income Households During the Summer
| NCT ID | NCT07583459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Carolina |
| Condition | Obesity & Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
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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.
This trial targets 300 participants in total. It began in 2026-05-01 with a primary completion date of 2030-06-30.
⚠ 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
Studies show that preschool-age children are especially vulnerable to accelerated weight gain during the summer, with those from low-income households (≤185% poverty level or Medicaid eligible - the target population for this study) exhibiting the greatest risk of unhealthy weight gain. Despite numerous interventions designed to prevent OWOB, none target preschoolers during summer. For families from low-income households, attending center-based childcare is associated with a lower risk of developing OWOB by 1st grade compared to attending home-based care. Center-based childcare lowers the risk of OWOB through daily rules/routines that promote healthy behaviors. For families from low-income households, publicly funded center-based childcares (e.g., needs-based pre-K, Head Start) typically operate on an academic/school 9-month calendar (Aug-May). During summer, fewer than 30% of preschoolers attend center-based childcare. For many preschoolers from lower-income households, summer may serve as an extended period away from formal center-based childcare, because the out-of-pocket expense may prohibit attendance. This may promote unhealthy behaviors and excessive weight gain. In the majority of US states, publicly funded center-based childcare during the academic/school year for families from underserved populations is free; however, center-based childcare during the summer is an out-of-pocket expense for many of these families. Despite parents' desire for childcare during the summer, a major reason children from low-income households do not attend center-based care during summer is cost. This creates unequal access to resources and likely exacerbates health disparities for families from low-income households. Using a structural intervention approach, this study will test the impact of providing free center-based childcare in the summer. This R01 will rigorously test the impact of providing free center-based childcare during the summer on weight status of preschoolers from low-income households (≤185% of poverty level or Medicaid eligible).
Eligibility Criteria
Inclusion Criteria: * Children will need to be enrolled in a needs-based pre-K program in our partner organizations to be eligible to participate. No other exclusion criteria will be applied Exclusion Criteria: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07583459 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 5 Years, studying Obesity & Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07583459 currently recruiting?
Yes, NCT07583459 is actively recruiting participants. Contact the research team at beets@mailbox.sc.edu for enrollment information.
Where is the NCT07583459 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT07583459 clinical trial?
NCT07583459 is sponsored by University of South Carolina. The trial plans to enroll 300 participants.
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