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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Child Obesity

Intervention / Treatment
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* Behavioral: Child Safety Control Intervention
* Behavioral: Responsive Parenting Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participating in the INSIGHT study. Exclusion Criteria: Unwilling to continue study participation for the study continuation.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INSIGHT participants<br>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<br>* 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.<br>Behavioral: Responsive Parenting Intervention<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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responsive parenting