Clinical trial NCT03555331: Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) - Long Term Follow-Up
Official title: Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) - Long Term Follow-Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Obesity
Keywords: responsive parenting
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Penn State University
name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University at Buffalo
name: University of Connecticut
First posted: 2018-06-13
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Participating in the INSIGHT study.

Exclusion Criteria:

* Unwilling to continue study participation for the study continuation.

Primary outcomes:
measure: 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
timeFrame: 6/2018 through 9/2024
Secondary outcomes:
measure: Mean BMI z-score
timeFrame: 6/2018 through 9/2024
measure: Proportion in each group overweight (BMI >=85th percentile) or obese (BMI >=95th percentile)
timeFrame: 6/2018 through 9/2024
measure: Test the sustained efficacy and long-term effects of an early life responsive parenting (RP) across the study period
timeFrame: 6/2018 through 9/2024
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: State College
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State Hershey Milton S Hershey Medical Center
name: Ian M Paul, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Jennifer Savage, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.