Abstract
OBJECTIVE: Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the first two years of life. DESIGN, PARTICIPANTS, AND METHODS: The design is a two-group randomized controlled trial among 468 AA pregnant women in central North Carolina. Mothers and study partners in the intervention group receive anticipatory guidance on breastfeeding, responsive feeding, use of non-food soothing techniques for infant crying, appropriate timing and quality of complementary feeding, age-appropriate infant sleep, and minimization of TV/media. The primary delivery channel is 6 home visits by a peer educator, 4 interim newsletters and twice-weekly text messaging. Intervention families also receive 2 home visits from an International Board Certified Lactation Consultant. Assessments occur at 28 and 37weeks gestation and when infants are 1, 3, 6, 9, 12, and 15months of age. RESULTS: The primary outcome is infant/toddler growth and likelihood of overweight at 15months. Differences between groups are expected to be achieved through uptake of the targeted infant feeding and care behaviors (secondary outcomes) and change in caregivers' modifiable risk factors (mediators) underpinning the intervention. CONCLUSIONS: If successful in promoting healthy infant growth and enhancing caregiver behaviors, "Mothers and Others" will have high public health relevance for future obesity-prevention efforts aimed at children younger than 2years, including interventional research and federal, state, and community health programs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01938118, August 9, 2013.