Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) - Long Term Follow-Up

NCT03555331 | Completed DMC

• 2 other identifiers: STUDY000034493R01DK088244
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 2

Brief Summary

Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT 2)-Long Term Follow-up will follow participants enrolled in the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) (NCT01167270) study from age 3 years through the developmentally important time at school-entry around age 6 years and into middle childhood at age 9.

Conditions

Child Obesity

Keywords

responsive parenting

Outcome Measures

Primary Outcomes (1)

• Efficacy of an early life responsive parenting (RP) intervention as demonstrated by a main effect for study group on BMI from ages 3 through 9 years

  Repeated measures ANOVA will be used to examine BMI change from ages 3 through 9 years, testing for persistence of the RP effect across time points, and also for an interaction between occasion and intervention group. Tests for an interaction between child sex and study group will be performed.

  6/2018 through 9/2024

Secondary Outcomes (3)

• Mean BMI z-score

  6/2018 through 9/2024

• Proportion in each group overweight (BMI >=85th percentile) or obese (BMI >=95th percentile)

  6/2018 through 9/2024

• Test the sustained efficacy and long-term effects of an early life responsive parenting (RP) across the study period

  6/2018 through 9/2024

Study Arms (1)

INSIGHT participants

Mother-child dyads who enrolled in the INSIGHT Study and participated from early infancy to age 3 years will be followed through age 9 years.

Behavioral: Child Safety Control Intervention; Behavioral: Responsive Parenting Intervention

Interventions

Child Safety Control Intervention BEHAVIORAL

In the study period which spanned from early infancy through age 3 years, the child safety intervention group was given an educational program with messages focused on child and home safety, guided by the American Academy of Pediatrics and the Academy's guide for health supervision, Bright Futures. The observation-only study extension will not include any intervention, rather it will assess any long term outcomes from the education given to parents when their children were 0-2 years old.

INSIGHT participants

Responsive Parenting Intervention BEHAVIORAL

During infancy, the Responsive Parenting group was given an educational program containing messages providing developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle aimed at preventing rapid weight gain in infancy and overweight at age 3 years. The new study period will not include any intervention, rather it will assess any long term outcomes from the education given to parents when their children were 0-2 years old.

INSIGHT participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

INSIGHT had a birth cohort of 279 infants and parents. Participating dyads received four home visits during the first year followed by annual clinic visits through age 3 years. This study extension will include actively participating parents and children from this original birth cohort that are willing to continue to be followed by the study team.

You may qualify if:

• Participating in the INSIGHT study.

You may not qualify if:

• Unwilling to continue study participation for the study continuation.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Penn State University: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University at Buffalo: collaborator
• University of Connecticut: collaborator

Study Sites (2)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Penn State University

State College, Pennsylvania, 16802, United States

Location

Related Publications (2)

• 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: 25037579 BACKGROUND

• Paul IM, Barton JM, Anzman-Frasca S, Hohman EE, Buxton OM, Hess LB, Savage JS. Long-Term Effects of a Responsive Parenting Intervention on Child Weight Outcomes Through Age 9 Years: The INSIGHT Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):827-835. doi: 10.1001/jamapediatrics.2024.6897.

  PMID: 40063048 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian M Paul, MD, MSc

  Penn State Hershey Milton S Hershey Medical Center

  PRINCIPAL INVESTIGATOR

• Jennifer Savage, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Public Health Sciences; Chief, Division of Academic General Pediatrics; Vice Chair of Faculty Affairs, Department of Pediatrics

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 13, 2018
• Study Start: June 7, 2018
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)