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

January 30, 2024 updated by: Ian M. Paul, MD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI percentile at 3 years
Time Frame: 3 years
BMI percentile at 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months of age
BMI percentile at age 2 years
Time Frame: 2 years of age
BMI percentile at age 2 years
2 years of age
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
aged 2 and 3 years
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
birth to 4 months, birth to 1 year, birth to 3 years, 1 year to 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
birth to 1 year of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ian M. Paul, MD

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimated)

July 22, 2010

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34493
  • 1R01DK088244-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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