Sleep SAAF: A responsive parenting intervention to prevent excessive weight gain and obesity among African American infants

Background: Responsive parenting interventions that shape parenting behaviors in the areas of sleep and soothing, appropriate and responsive feeding, and routines represent a promising approach to early obesity prevention and have demonstrated effectiveness in our previous trials. However, this approach has yet to be applied to the populations most at-risk for the development of early obesity, including African Americans. The Sleep SAAF (Strong African American Families) study is a two-arm randomized controlled clinical trial evaluating whether a responsive parenting intervention focused on promoting infant sleeping and self-soothing can prevent rapid weight gain during the first 16 weeks postpartum among first-born African American infants. The responsive parenting intervention is compared to a child safety control intervention. Methods: Three hundred first-time African American mothers and their full-term infants will be enrolled from one mother/baby nursery. Following initial screening and consent in the hospital, mothers and infants are visited at home by Community Research Associates for data collection visits at 1 week, 8 weeks, and 16 weeks postpartum and for intervention visits at 3 weeks and 8 weeks postpartum. The primary study outcome is a between-group comparison of infant conditional weight gain (CWG) scores from 3 weeks to 16 weeks; additional weight-related outcomes include differences in change in infants' weight for age over time and differences in infants' weight outcomes at age 16 weeks. Several other outcomes reflecting infant and maternal responses to intervention (e.g., sleeping, soothing, feeding, maternal self-efficacy, maternal depressive symptoms) are also assessed. Discussion: The Sleep SAAF trial can inform efforts to prevent rapid weight gain and reduce risk for obesity early in the lifespan among African Americans. Trial registration: NCT03505203. Registered April 3, 2018 in clinicaltrials.gov.