NCT01167270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

5.3 years

First QC Date

July 21, 2010

Last Update Submit

January 30, 2024

Conditions

InfantObesity

Keywords

Infant DietToddler DietResponsive FeedingInfant TemperamentParent competencyChildhood Obesity preventionRapid infant weight gain

Outcome Measures

Primary Outcomes (1)

  • BMI percentile at 3 years

    BMI percentile at 3 years

    3 years

Secondary Outcomes (4)

  • Weight-for-length percentile at several intervals in the first 12 months after birth

    12 months 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

    aged 2 and 3 years

  • Proportion of infants with accelerated weight gain between numerous study intervals

    birth to 4 months, birth to 1 year, birth to 3 years, 1 year to 3 years

Other Outcomes (1)

  • Factors that influence the succession of the oral and gut microbiomes.

    birth to 1 year of age

Study Arms (2)

Parenting Insight

ACTIVE COMPARATOR

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

Child Safety Insights

PLACEBO COMPARATOR

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

Interventions

Child Safety InsightsBEHAVIORAL

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.

Child Safety Insights
Parenting InsightsBEHAVIORAL

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.

Parenting Insight

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Penn State University

State College, Pennsylvania, 16802, United States

Location

Related Publications (21)

  • 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.

    PMID: 25037579BACKGROUND

  • 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):e20160762. doi: 10.1542/peds.2016-0762.

    PMID: 27354460RESULT

  • 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.

    PMID: 27271455RESULT

  • Paul IM, Hohman EE, Birch LL, Shelly A, Vallotton CD, Savage JS. Exploring infant signing to enhance responsive parenting: Findings from the INSIGHT study. Matern Child Nutr. 2019 Jul;15(3):e12800. doi: 10.1111/mcn.12800. Epub 2019 Mar 19.

    PMID: 30810273RESULT

  • Craig SJC, Blankenberg D, Parodi ACL, Paul IM, Birch LL, Savage JS, Marini ME, Stokes JL, Nekrutenko A, Reimherr M, Chiaromonte F, Makova KD. Child Weight Gain Trajectories Linked To Oral Microbiota Composition. Sci Rep. 2018 Sep 19;8(1):14030. doi: 10.1038/s41598-018-31866-9.

    PMID: 30232389RESULT

  • Eagleton SG, Hohman EE, Verdiglione N, Birch LL, Paul IM, Savage JS. INSIGHT Study Maternal Return to Work and Infant Weight Outcomes. Acad Pediatr. 2019 Jan-Feb;19(1):67-73. doi: 10.1016/j.acap.2018.08.008. Epub 2018 Aug 23.

    PMID: 30145361RESULT

  • Savage JS, Hohman EE, Marini ME, Shelly A, Paul IM, Birch LL. INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Int J Behav Nutr Phys Act. 2018 Jul 9;15(1):64. doi: 10.1186/s12966-018-0700-6.

    PMID: 29986721RESULT

  • Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Beiler JS, Hess LB, Loken E, Birch LL. Effect of a Responsive Parenting Educational Intervention on Childhood Weight Outcomes at 3 Years of Age: The INSIGHT Randomized Clinical Trial. JAMA. 2018 Aug 7;320(5):461-468. doi: 10.1001/jama.2018.9432.

    PMID: 30088009RESULT

  • Anzman-Frasca S, Paul IM, Moding KJ, Savage JS, Hohman EE, Birch LL. Effects of the INSIGHT Obesity Preventive Intervention on Reported and Observed Infant Temperament. J Dev Behav Pediatr. 2018 Dec;39(9):736-743. doi: 10.1097/DBP.0000000000000597.

    PMID: 29927795RESULT

  • 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.

    PMID: 29544506RESULT

  • Hohman EE, Savage JS, Birch LL, Beiler JS, Paul IM. Pacifier Use and Early Life Weight Outcomes in the Intervention Nurses Start Infants Growing on Healthy Trajectories Study. Child Obes. 2018 Jan;14(1):58-66. doi: 10.1089/chi.2017.0177. Epub 2017 Oct 4.

    PMID: 28976781RESULT

  • Paul IM, Hohman EE, Loken E, Savage JS, Anzman-Frasca S, Carper P, Marini ME, Birch LL. Mother-Infant Room-Sharing and Sleep Outcomes in the INSIGHT Study. Pediatrics. 2017 Jul;140(1):e20170122. doi: 10.1542/peds.2017-0122. Epub 2017 Jun 5.

    PMID: 28759407RESULT

  • Carney MC, Tarasiuk A, DiAngelo SL, Silveyra P, Podany A, Birch LL, Paul IM, Kelleher S, Hicks SD. Metabolism-related microRNAs in maternal breast milk are influenced by premature delivery. Pediatr Res. 2017 Aug;82(2):226-236. doi: 10.1038/pr.2017.54. Epub 2017 May 24.

    PMID: 28422941RESULT

  • Hohman EE, Paul IM, Birch LL, Savage JS. INSIGHT responsive parenting intervention is associated with healthier patterns of dietary exposures in infants. Obesity (Silver Spring). 2017 Jan;25(1):185-191. doi: 10.1002/oby.21705.

    PMID: 28008749RESULT

  • Dadzie A, Master L, Hohman EE, Acton EH, Tauriello S, Paul IM, Savage JS, Anzman-Frasca S, Buxton OM. Associations Between Sleep Health and Child Behavior at Age 6 Years in the INSIGHT Study. J Dev Behav Pediatr. 2025 Jan-Feb 01;46(1):e56-e63. doi: 10.1097/DBP.0000000000001326. Epub 2024 Nov 8.

    PMID: 39514718DERIVED

  • Hernandez Acton E, Kubiniec E, Bhargava S, Tauriello S, Paul IM, Savage JS, Anzman-Frasca S. INSIGHT responsive parenting intervention effects on child self-regulation at ages 3 and 6 years. Dev Psychol. 2025 Aug;61(8):1413-1426. doi: 10.1037/dev0001839. Epub 2024 Sep 26.

    PMID: 39325391DERIVED

  • Tauriello S, Savage JS, Goldsmith J, Kubiniec E, Paul IM, Anzman-Frasca S. Effect of the INSIGHT Responsive Parenting Intervention on Parenting and Child Behavior at Ages 3 and 6 Years. J Pediatr. 2023 Apr;255:72-79. doi: 10.1016/j.jpeds.2022.10.025. Epub 2022 Oct 29.

    PMID: 37081779DERIVED

  • Hohman EE, Savage JS, Marini ME, Anzman-Frasca S, Buxton OM, Loken E, Paul IM. Effect of the INSIGHT Firstborn Parenting Intervention on Secondborn Sleep. Pediatrics. 2022 Jul 1;150(1):e2021055244. doi: 10.1542/peds.2021-055244.

    PMID: 35703026DERIVED

  • Hyczko AV, Ruggiero CF, Hohman EE, Anzman-Frasca S, Savage JS, Birch LL, Paul IM. Sex Differences in Maternal Restrictive Feeding Practices in the Intervention Nurses Start Infants Growing on Healthy Trajectories Study. Acad Pediatr. 2021 Aug;21(6):1070-1076. doi: 10.1016/j.acap.2021.05.002. Epub 2021 May 19.

    PMID: 34020105DERIVED

  • Hohman EE, Savage JS, Birch LL, Paul IM. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Responsive Parenting Intervention for Firstborns Affects Dietary Intake of Secondborn Infants. J Nutr. 2020 Aug 1;150(8):2139-2146. doi: 10.1093/jn/nxaa135.

    PMID: 32412629DERIVED

  • Adams EL, Marini ME, Brick TR, Paul IM, Birch LL, Savage JS. Ecological momentary assessment of using food to soothe during infancy in the INSIGHT trial. Int J Behav Nutr Phys Act. 2019 Sep 5;16(1):79. doi: 10.1186/s12966-019-0837-y.

    PMID: 31488156DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leann L Birch, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Ian M Paul, MD, MSc

    Penn State College of Medicine and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pediatrics and Public Health Sciences

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 22, 2010

Study Start

January 1, 2012

Primary Completion

April 1, 2017

Study Completion

December 31, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

US(2)