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

NCT07583459 | Not Yet Recruiting DMC

• 1 other identifier: USouthCarolina
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Obesity & Overweight

Keywords

Obesity; Preschool; Community; Intervention

Outcome Measures

Primary Outcomes (2)

• Bioelectrical Impedance

  Bioelectrical Impedance (BIA) will be used as a measure of children's body composition. This will allow for the quantification of whole-body fat mass and fat free mass associated with changes over school and summer. BIA will be collected via the Inbody 270 (Seoul, South Korea), which is validated for use in 3-4 yr-old children.

  Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months)

• BMI z-score

  BMI z-score is a age-sex standardized metric of BMI (height and weight)

  Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Childcare

Control

NO INTERVENTION

The control group will not receive free access to attend the center-based childcare during the summer.

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

Intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of South Carolina: lead

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michael W Beets, MEd, MPH, PhD

CONTACT

8037773003; beets@mailbox.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and data collectors will be blinded to participant allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 13, 2026

Record last verified: 2026-05