2.2. Study Setting and Participants
RECRUITMENT
To be eligible to participate in the ¡Míranos! RCT, Head Start centers must have had ≥75% of enrolled children identify as Latino, an onsite outdoor playground, serve meals from the center’s central kitchen, agreement to not participate in new health-related research studies during the study period, and agreement to treatment randomization. Children were eligible if they were 3 years old at the beginning of the school year and enrolled in a 3-year-old-only classroom at a participating Head Start center. Only one child per family was included in the study. If more than one child from a family was identified, we only included the first child encountered by data-collection staff. Parents/guardians signed an informed consent for their child to participate in the ¡Míranos! trial. Participants were recruited in two cohorts (Cohort 1: August 2018–May 2020; Cohort 2: August 2019–May 2021). Due to the COVID-19 pandemic, posttest gross motor assessments were not conducted in Cohort 2 participants, who were excluded from this study’s analyses. Participants who had a missing measure of body mass index, the primary outcome measure, were also excluded from this study.We randomly assigned 12 Head Start centers to the combined center- and home-based intervention (CBI + HBI), the center-based only intervention (CBI), and control condition in a 1:1:1 ratio. The treatment conditions were concealed from the participants until completion of baseline assessments. The investigators and research staff were not blinded to treatment conditions. A full description of the recruitment and randomization process was published previously [