CHAMP: A cluster randomized-control trial to prevent obesity in child care centers

Foundational elements of lifelong health are formed during the preschool years. Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity. Despite the promising evidence of efficacy of child care-based obesity prevention interventions, limited attention has been directed to criteria needed for implementation at scale. There is potential to improve children's dietary and physical activity behaviors in diverse communities through theory-based, culturally appropriate, manualized interventions, delivered by child care staff. CHAMP (Creating Healthy Habits Among Maryland Preschoolers) is a 3-arm cluster randomized controlled childhood obesity prevention trial, aiming to improve motor skills, physical activity and willingness to try new foods among 864 preschoolers (age 3-5 years) enrolled in 54 child care centers in 10 Maryland counties. CHAMP is informed by social-cognitive and bioecological theories and based on an evidence-based program, The Food Friends®. The two intervention arms include: 1) child care-center based lessons (18-week gross motor and 12-week nutrition) administered by trained child care staff, and 2) a web-based intervention for caregivers in addition to center-based lessons. Evaluations are conducted among children, caregivers, and child care staff at fall enrollment, midline, and spring, following intervention completion. Analyses include linear mixed-models, accounting for clustering and repeated measures, incorporating center-arms as moderators. CHAMP will provide evidence-based information to inform wellness guidelines and policies that can be disseminated broadly, to ensure that child care centers provide opportunities for children to develop healthy eating, and physical activity habits. Trial Registration: NCT03111264; https://clinicaltrials.gov/ct2/show/NCT03111264.