Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-07

Study Completion Date

2024-11-15

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.

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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.

Conditions

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Child Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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INSIGHT participants

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.

Child Safety Control Intervention

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participating in the INSIGHT study.

Exclusion Criteria

* Unwilling to continue study participation for the study continuation.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ian M. Paul, MD

Professor of Pediatrics and Public Health Sciences; Chief, Division of Academic General Pediatrics; Vice Chair of Faculty Affairs, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR