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

10 juni 2026 uppdaterad av: Michael Beets, University of South Carolina
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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • South Carolina
      • Columbia, South Carolina, Förenta staterna, 29208
        • Rekrytering
        • University of South Carolina
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Ja

Beskrivning

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:

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
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
Inget ingripande: Control
The control group will not receive free access to attend the center-based childcare during the summer.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bioelectrical Impedance
Tidsram: Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months)
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
Tidsram: Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months)
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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

30 juni 2030

Avslutad studie (Beräknad)

30 juni 2030

Studieregistreringsdatum

Först inskickad

29 april 2026

Först inskickad som uppfyllde QC-kriterierna

6 maj 2026

Första postat (Faktisk)

13 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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