The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study

Principal Hypotheses: An intervention program designed to provide developmentally appropriate
guidance to parents of infants on responsive parenting and healthy lifestyle will prevent
rapid weight gain in infancy and overweight at age 3 years. Further, compared with control
infants, intervention infants will have lower BMI percentiles at age 3. We also hypothesize
that control infants will gain weight more rapidly over time, adjusting for trait-stable and
time-varying covariates (e.g., maternal pre-pregnancy BMI, percent of feedings that are
breast milk vs. formula, sleep duration, and feeding frequency).

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study, will
test these hypotheses in a two arm randomized trial where participants in a program to
prevent childhood obesity will be compared with those in a child safety control program.
Nurses will deliver interventions to first-time parents and their infants in both study
groups at four home visits in the first year after birth followed by annual clinical research
center visits until age 3. Blood samples for genetic testing on appetite, growth, and
temperament will be collected from mother, child, and father. The obesity prevention program
focuses on messages of responsive parenting and healthy lifestyle, extending from infancy
through age 3 years. The intervention will teach first-time parents to interact with their
infants in a way that is prompt, emotionally supportive, contingent, and developmentally
appropriate. This information is especially important during the first year after birth as
infants make a dramatic dietary transition from the initial exclusive milk diet to one with
many foods of the adult diet of their culture. During this transition, as foods are being
introduced to children, there are numerous opportunities to address dietary content as well
as parent feeding style. In addition to these messages, intervention parents will be given
education on growth charts, the meaning of growth chart percentiles, and healthy growth
patterns during early life. The intervention program is hypothesized to show efficacy in both
breast and formula fed infants as measured by the primary outcome, body mass index (BMI)
percentile at age 3 years. Additionally, participants will be followed to collect
anthropometric measurements at 4,5,6,10,14,and 17 years of age to provide significant insight
into long-term obesity risk.

The proposed research adds two major pieces by enrolling second born siblings and collecting
genetic specimens from both siblings and their parents. Specifically, this translational
research will a) prospectively evaluate obesity-related parenting similarities and
differences as well as weight-related outcomes between first and second-born siblings, b)
explore how genetic differences among siblings that are associated with appetite,
temperament, and obesity susceptibility affect parent-child interactions, degree of
responsive parenting, and weight status, and c) determine whether INSIGHT study intervention
carryover effects occur among families participating in the observation-only second-born
child evaluation.

Inclusion Criteria:

- full-term infant(> 37 0/7 weeks gestational age)discharged from hospital without
significant morbidity

- singleton infant

- nursery/NICU/maternity stay of 7 days or less

- primiparous mother

- English speaking mother

Exclusion Criteria:

- presence of a congenital anomaly or neonatal condition that significantly affects a
newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease

- any major maternal morbidities and/or pre-existing condition that would affect
postpartum care such as cancer, multiple sclerosis, lupus, etc.

- maternal age <=20 years

- prenatal ultrasound presence of intrauterine growth retardation (IUGR)

- infant birth weight <2500 grams plan for newborn to be adopted

- plan to move from Central Pennsylvania within 3 years

- inability to complete contact form with name, address, phone numbers, etc.

- Practicing pediatrician or pediatric resident