Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) - Long Term Follow-Up
- Conditions
- Child Obesity
- Interventions
- Behavioral: Child Safety Control InterventionBehavioral: Responsive Parenting Intervention
- Registration Number
- NCT03555331
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
- Participating in the INSIGHT study.
- Unwilling to continue study participation for the study continuation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description INSIGHT participants Child Safety Control Intervention 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. INSIGHT participants Responsive Parenting Intervention 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.
- Primary Outcome Measures
Name Time Method 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 6/2018 through 9/2024 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.
- Secondary Outcome Measures
Name Time Method Mean BMI z-score 6/2018 through 9/2024 ANOVA at ages 5, 6, and 9 years.
Test the sustained efficacy and long-term effects of an early life responsive parenting (RP) across the study period 6/2018 through 9/2024 Repeated measures ANOVA will be used to examine BMI change from ages 3-4 weeks through 9 years.
Proportion in each group overweight (BMI >=85th percentile) or obese (BMI >=95th percentile) 6/2018 through 9/2024 Logistic regression analysis will be used to examine the intervention effects on the overweight/obese outcomes at 5, 6, and 9 years.
Trial Locations
- Locations (2)
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Penn State University
🇺🇸State College, Pennsylvania, United States