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

Ian M. Paul, MD

Status: Completed

Conditions: Obesity; Infant

Treatments: Behavioral: Child Safety Insights; Behavioral: Parenting Insights

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01167270

34493

1R01DK088244-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will test an intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle to see if that intervention will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower body mass index (BMI) percentiles at age 3. The investigators also hypothesize that control infants will gain weight more rapidly over time.

Full description

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.

Enrollment: 316 patients

Sex: All

Ages: 1+ day old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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316 participants in 2 patient groups, including a placebo group

Parenting Insight

Active Comparator group

Description:

Educational program contains messages to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle that will prevent rapid weight gain in infancy and overweight at age 3 years.

Treatment:

Behavioral: Parenting Insights

Child Safety Insights

Placebo Comparator group

Description:

A child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the AAP guidelines and the Academy's guide for health supervision, Bright Futures

Treatment:

Behavioral: Child Safety Insights