Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Penn State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ian M. Paul, M.D., M.Sc., Penn State University
ClinicalTrials.gov Identifier:
NCT01167270
First received: July 21, 2010
Last updated: May 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Infant
Obesity
Behavioral: Child Safety Insights
Behavioral: Parenting Insights

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • BMI percentile at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight-for-length percentile at several intervals in the first 12 months after birth [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
  • BMI percentile at age 2 years [ Time Frame: 2 years of age ] [ Designated as safety issue: No ]
  • Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3 years [ Time Frame: aged 2 and 3 years ] [ Designated as safety issue: No ]
  • Proportion of infants with accelerated weight gain between numerous study intervals [ Time Frame: birth to 4 months, birth to 1 year, birth to 3 years, 1 year to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 316
Study Start Date: January 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Parenting Insight
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.
Behavioral: Parenting Insights
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.
Placebo Comparator: Child Safety Insights
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
Behavioral: Child Safety Insights
A child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the American Academy of Pediatrics as well as the Academy's guide for health supervision, Bright Futures.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167270

Contacts
Contact: Jessica SB Beiler, MPH 717-531-5656 jbeiler@hmc.psu.edu
Contact: Jennifer L Stokes, RN 717-531-5656 jstokes1@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Jessica SB Beiler, MPH         
Principal Investigator: Ian M Paul, MSc         
Sub-Investigator: Jennifer L Stokes, RN         
Sub-Investigator: Jessica SB Beiler, MPH         
Penn State University Not yet recruiting
State College, Pennsylvania, United States, 16802
Contact: Michele Marini, MS       mem44@psu.edu   
Principal Investigator: Leann L Birch, PhD         
Sub-Investigator: Jennifer Savage, PhD         
Sub-Investigator: Michele Marini, MS         
Sub-Investigator: Stephanie Anzman-Frasca, PhD         
Sub-Investigator: Michael Rovine, PhD         
Sponsors and Collaborators
Ian M. Paul, M.D., M.Sc.
Investigators
Principal Investigator: Leann L Birch, PhD Penn State University
Principal Investigator: Ian M Paul, MD, MSc Penn State College of Medicine and Children's Hospital
  More Information

No publications provided by Penn State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ian M. Paul, M.D., M.Sc., Professor of Pediatrics and Public Health Sciences, Penn State University
ClinicalTrials.gov Identifier: NCT01167270     History of Changes
Other Study ID Numbers: 34493
Study First Received: July 21, 2010
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Infant Diet
Toddler Diet
Responsive Feeding
Infant Temperament
Parent competency
Childhood Obesity prevention
Rapid infant weight gain

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014