Background: Poor feeding practices during infancy contribute to obesity risk. As infants transition from human milk and/or formula-based diets to solid foods, these practices interfere with infant feeding self-regulation and healthy growth patterns. Compared with other socioeconomic groups, lower-income mothers are more likely to experience difficulty feeding their infants. This may include misinterpreting feeding cues and using less-than-optimal feeding styles and practices, such as pressuring infants during mealtimes and prematurely introducing solid food and sweetened beverages. The Healthy Babies trial aims to determine the efficacy of a community-based randomized controlled trial of an in-home intervention with economically and educationally disadvantaged mother-infant dyads. The educational intervention is being conducted during the infant's first 6 months of life to promote healthy transition to solids during their first year and is based on the theory of planned behavior.
Methods/design: We will describe our study protocol for a multisite randomized control trial being conducted in Colorado and Michigan with an anticipated sample of 372 economically and educationally disadvantaged African American, Hispanic, and Caucasian mothers with infants. Participants are being recruited by county community agency staff. Participants are randomly assigned to the intervention or the control group. The intervention consists of six in-home visits by a trained paraprofessional instructor followed by three reinforcement telephone contacts when the baby is 6, 8, and 10 months old. Main maternal outcomes include a) maternal responsiveness, b) feeding style, and c) feeding practices. Main infant outcome is infant growth pattern. All measures occur at baseline and when the infant is 6 and 12 months old.
Discussion: If this project is successful, the expected outcomes will address whether the home-based early nutrition education intervention is effective in helping mothers develop healthy infant feeding practices that contribute to improving infant health and development and reducing the risk of early-onset childhood obesity.
Trial registration: Current Controlled Trials ACTRN126100000415000.