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

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ClinicalTrials.gov Identifier: NCT01167270
Recruitment Status : Active, not recruiting
First Posted : July 22, 2010
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ian M. Paul, MD, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE July 21, 2010
First Posted Date  ICMJE July 22, 2010
Last Update Posted Date August 22, 2019
Study Start Date  ICMJE January 2012
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
BMI percentile at 3 years [ Time Frame: 3 years ]
BMI percentile at 3 years
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
BMI percentile at 3 years [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT01167270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • 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
  • BMI percentile at age 2 years [ Time Frame: 2 years of age ]
    BMI percentile at age 2 years
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
  • Weight-for-length percentile at several intervals in the first 12 months after birth [ Time Frame: 12 months of age ]
  • BMI percentile at age 2 years [ Time Frame: 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 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: July 28, 2017)
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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study
Official Title  ICMJE The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Infant
  • Obesity
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Parenting Insights
  • 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
    Intervention: Behavioral: Child Safety Insights
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 20, 2014)
316
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2010)
276
Estimated Study Completion Date  ICMJE June 2023
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01167270
Other Study ID Numbers  ICMJE 34493
1R01DK088244-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ian M. Paul, MD, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Ian M. Paul, MD
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
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
PRS Account Milton S. Hershey Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP