View Clinical Trial (Medical Research Study)
The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Infant - Obesity |
| Purpose: |
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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.
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| Study Summary: |
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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. 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. This outcome provides significant insight into long-term obesity risk.
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| Criteria: |
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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
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| NCT ID: |
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NCT01167270 |
| Primary Contact: |
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Principal Investigator
Leann L Birch, PhD
Penn State University
Jessica SB Beiler, MPH
Phone: 717-531-5656
Email: jbeiler@hmc.psu.edu
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| Backup Contact: |
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Email: jstokes1@hmc.psu.edu
Jennifer L Stokes, RN
Phone: 717-531-5656
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| Location Contact: |
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Hershey, Pennsylvania 17033
United States
Jessica SB Beiler, MPH
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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