The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project

Obesity Clinical Trial

Official title: Primary Prevention of Obesity Through Infancy Interventions

Status Completed

Clinical Trial Summary

Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.

Clinical Trial Description

Rationale: Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. A recent report from the National Health and Nutrition Examination Survey (NHANES) revealed that between 2003-2004, a staggering 26.2% of children aged 2 to 5 years were already overweight or at-risk for overweight. As such, in the summary of the "Conference on Preventing Childhood Obesity," it was remarked that researchers should particularly consider the youngest of children when planning obesity related interventions. Because the current evidence base regarding potentially effective early intervention components is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.

Key Objectives:

Aim 1: To evaluate the effect of simple procedures, taught to parents in the home environment by visiting nurses, that trains parents to calm their infants and increase their nocturnal sleep duration, thereby influencing sleep duration, nocturnal feeding frequency, and weight gain during infancy.

Aim 2: To evaluate a simple training procedure for parents, taught in the home environment by visiting nurses, that promotes infants' acceptance of nutritious, developmentally appropriate weaning foods.

Aim 3: To evaluate the delivery of these behavioral interventions to parents by community based home health nurses.

Aim 4: To examine the effect of a soothing intervention designed to increase sleep duration on overall maternal regulation of emotion, self-regulation of emotion, and weight gain.

Study Population: 160 newborns and mothers that demonstrate intent to breastfeed during the newborn nursery stay will be recruited during the maternity hospitalization. Approximately 25-50 physicians from the university affiliated pediatric and family practices. ;

Related Conditions & MeSH terms

• Obesity
• Weight Gain

• NCT number: NCT00359242
• Study type: Interventional
• Source: Milton S. Hershey Medical Center
• Status: Completed
• Phase: Phase 1
• Start date: June 2006
• Completion date: December 2009