Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design

Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs. 1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care. The lifestyle intervention focuses on age-appropriate infant physical activation, healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling. It is being tested among caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12 months of age. The main outcome is infant rate of weight gain at 12 months; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors. We are also recording fees, time and personnel involved in the intervention development, maintenance and dissemination. If successful, the intervention could be incorporated as a ‘best practice’ through WIC policy as a means to strengthen obesity prevention efforts to improve minority health and eliminate health disparities among Hispanics and possibly other at-risk groups beyond the childhood period. Clinicaltrials.gov registration: NCT03517891.