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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Infant; Obesity	Behavioral: Child Safety Insights; Behavioral: Parenting Insights	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	316 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study
Study Start Date :	January 2012
Actual Primary Completion Date :	April 2017
Estimated Study Completion Date :	June 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. BMI percentile at 3 years [ Time Frame: 3 years ]
   BMI percentile at 3 years

Secondary Outcome Measures :

1. Weight-for-length percentile at several intervals in the first 12 months after birth [ Time Frame: 12 months of age ]
   Weight-for-length percentile at several intervals in the first 12 months after birth
2. BMI percentile at age 2 years [ Time Frame: 2 years of age ]
   BMI percentile at age 2 years
3. Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3 years [ Time Frame: aged 2 and 3 years ]
   Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3
4. 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 ]
   Proportion of infants with accelerated weight gain between numerous study

Other Outcome Measures:

1. Factors that influence the succession of the oral and gut microbiomes. [ Time Frame: birth to 1 year of age ]
   Microbiome samples collected from mother and baby throughout the first year of life (including stool and buccal swabs) are collected for analyses. Outcome only for the sibling study not the first born study

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Penn State University
State College, Pennsylvania, United States, 16802

Sponsors and Collaborators

Ian M. Paul, MD

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Mindell JA, Birch LL. INSIGHT Responsive Parenting Intervention and Infant Sleep. Pediatrics. 2016 Jul;138(1). pii: e20160762. doi: 10.1542/peds.2016-0762.

Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1001/jamapediatrics.2016.0445.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Adams EL, Marini ME, Stokes J, Birch LL, Paul IM, Savage JS. INSIGHT responsive parenting intervention reduces infant's screen time and television exposure. Int J Behav Nutr Phys Act. 2018 Mar 15;15(1):24. doi: 10.1186/s12966-018-0657-5.

Paul IM, Williams JS, Anzman-Frasca S, Beiler JS, Makova KD, Marini ME, Hess LB, Rzucidlo SE, Verdiglione N, Mindell JA, Birch LL. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. BMC Pediatr. 2014 Jul 18;14:184. doi: 10.1186/1471-2431-14-184.

Responsible Party:	Ian M. Paul, MD, Professor of Pediatrics and Public Health Sciences, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:	NCT01167270 History of Changes
Other Study ID Numbers:	34493; 1R01DK088244-01 ( U.S. NIH Grant/Contract )
First Posted:	July 22, 2010
Last Update Posted:	August 1, 2017
Last Verified:	July 2017

Keywords provided by Ian M. Paul, MD, Penn State Milton S. Hershey Medical Center:

Infant Diet; Toddler Diet; Responsive Feeding; Infant Temperament	Parent competency; Childhood Obesity prevention; Rapid infant weight gain