An observational study in Child Obesity, sponsored by Milton S. Hershey Medical Center. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Milton S. Hershey Medical Center · Observational
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.
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 216 is close to the median of 200 across 231 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
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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.
Exclusion Criteria:
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
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.
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.
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.
Time frame: 6/2018 through 9/2024
Mean BMI z-score
ANOVA at ages 5, 6, and 9 years.
Time frame: 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.
Time frame: 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.
Time frame: 6/2018 through 9/2024
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center