3 Clinical Trials for Various Conditions
The purpose of this study is to determine if children and mothers who participate in the First Born® Program (FBP) experience better outcomes than they would have in the absence of the program. The evaluation employs a randomized trial design to assess the effectiveness of the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses clinically trained professionals to provide first-time parents with information, training, and access to resources designed to promote early childhood development. Services are free and may begin at any time during pregnancy or up to two months after the baby's birth and may continue until the child is three years old. In addition, a nurse postpartum home visit is offered to the parents of all participating newborns. The FBP model builds on other home visiting and prevention programs that have been shown to improve long-term outcomes of children and their families.
The objective of this study is to examine how infant egg consumption (age of introduction and frequency of intake) influences physical growth, obesity, cardio-metabolic health, risk of food allergy, and cognition development in mid-childhood and adolescence.
Specific Aim: Feasibility of a Pilot Randomized Controlled Trial (RCT) in Pregnancy and Infancy to Reduce Childhood Obesity Risk Factors in Early Life. The main outcomes are feasibility of the intervention components and data collection. Study will use maternal body mass index (BMI) and child weight-for-length outcomes to estimate sample size needed for a full-scale trial to test intervention efficacy. Primary analysis for full-scale trial power and sample size calculations will be conducted using child weight-for-length data at Child Age 12 Months Visit. Data collected will inform future interventions.