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

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.

Study Overview

• Status: Completed
• Conditions: Child Obesity
• Intervention / Treatment: Behavioral: Child Safety Control Intervention; Behavioral: Responsive Parenting Intervention

Detailed Description

INSIGHT(NCT01167270) is a randomized, clinical trial evaluating a responsive parenting (RP) intervention designed to prevent rapid infant weight gain and childhood obesity among first-born infants. RP has been shown to promote a range of adaptive outcomes in children including secure attachment, cognitive development, and self-regulation of emotions and behavior with the potential for many beneficial effects including obesity prevention. INSIGHT's RP intervention is being compared with a home safety control intervention using a birth cohort of 279 infants and parents who received four home visits during the first year followed by annual clinic visits through age 3 years.

The study team will now follow the INSIGHT cohort with growth measurements from ages 5-9 years and with an in-depth assessment of parenting and child behaviors around the time of grade school entry at age 6. The study extension is observational and participants will not be given any further parenting or safety guidance as described in the initial grant.

• Study Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Participating in the INSIGHT study.

Exclusion Criteria:

• Unwilling to continue study participation for the study continuation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Behavioral: Responsive Parenting Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean BMI z-score	ANOVA at ages 5, 6, and 9 years.	6/2018 through 9/2024
Proportion in each group overweight (BMI >=85th percentile) or obese (BMI >=95th percentile)	Logistic regression analysis will be used to examine the intervention effects on the overweight/obese outcomes at 5, 6, and 9 years.	6/2018 through 9/2024
Test the sustained efficacy and long-term effects of an early life responsive parenting (RP) across the study period	Repeated measures ANOVA will be used to examine BMI change from ages 3-4 weeks through 9 years.	6/2018 through 9/2024

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH); University at Buffalo; Penn State University; University of Connecticut
• Investigators: Principal Investigator: Jennifer Savage, PhD, Penn State University; Principal Investigator: Ian M Paul, MD, MSc, Penn State Hershey Milton S Hershey Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 13, 2018

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: responsive parenting
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: STUDY000034493; R01DK088244 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No