Efficacy of Center-based Childcare to Mitigate Unhealthy Weight Gain in Preschoolers From Low-income Households During the Summer

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
University of South Carolina
Study ID
NCT07583459
Status
Recruiting

Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
3 Years - 5 Years
Healthy Volunteers
Accepted

Interventions

  • Childcare — BEHAVIORAL
    Daily Schedule: The daily schedule will be from \~8am to 5pm M-F. The centers will provide lunch, snacks, and a nap. The activities each day will focus on core state curriculum standards for reading, social emotional learning, and kindergarten readiness. Preschoolers will be offered 2-3 15-20min recess periods each day and be provided physical education for 45min on a rotating 2/3 schedule every 2 weeks (i.e., 2 days/week followed by 3 days/week). Meals: All meals provided will be reimbursed through the district's Summer Food Service Program and will adhere to the nutritional guidelines of the Summer Food Service Program. The program will be overseen by district personnel who are responsible for pre-K during the 9m school year. Staffing: The program will be staffed by pre-K teachers who teach in the district. Teachers have already expressed interest in staffing the summer program and will be recruited by organization personnel. Setting: The center-based childcare wil

Study Details

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).

Key Dates

Start date
May 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    Children randomly assigned to receive free center-based childcare during the summer will be provided 8 to 10 weeks (depending on the length of summer - which can vary due to school-year closures and make-up days) of access to a school-operated, needs-based center-based childcare during the summer.
  • No Intervention: Control
    The control group will not receive free access to attend the center-based childcare during the summer.

Primary Outcome Measure

Bioelectrical Impedance [ Time Frame: Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South CarolinaColumbiaSouth Carolina29208
Michael Beets, PhD
8037773003

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