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

Child Obesity Clinical Trial

— INSIGHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555331
• Other study ID #: STUDY000034493
• Secondary ID: R01DK088244
• Status: Completed
• Start date: June 7, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participating in the INSIGHT study.

Exclusion Criteria:

• Unwilling to continue study participation for the study continuation.

Related Conditions & MeSH terms

• Child Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Penn State University	State College	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Penn State University, University at Buffalo, University of Connecticut

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean BMI z-score	ANOVA at ages 5, 6, and 9 years.	6/2018 through 9/2024
Secondary	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
Secondary	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