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

Primary Prevention of Obesity Through Infancy Interventions

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Gain
• Intervention / Treatment: Behavioral: Infant Sleeping and Soothing; Behavioral: Repeated Food Exposure

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 34 0/7 weeks gestational age
• Discharged from the newborn nursery or neonatal intensive care unit (NICU) without significant neonatal morbidity
• Singleton infant
• Nursery or NICU stay of 7 days or less
• Primiparous mother
• Maternity stay of 7 days or less
• Pediatric primary care provider from one of 3 University-affiliated pediatric practices or University-affiliated family medicine practices
• Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
• English speaking mother.

Exclusion Criteria:

• Newborn nursery, NICU, or maternity stay > 7 days
• Exclusive formula feeding in the nursery or NICU
• Multiparous mother
• Any metabolic condition that requires feedings at precise intervals
• Gestational age of 33 6/7 weeks or less
• Presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip or cleft palate) or sleeping (hyperexplexia - exaggerated startle reflex)
• Non-singleton newborn

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Soothing and Calming instructions given at 2 weeks of life	Behavioral: Infant Sleeping and Soothing; Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.
Experimental: 2; Repeated food exposure instructions given between 4 and 6 months of life	Behavioral: Repeated Food Exposure; Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.
Experimental: 3; Receive both interventions: Soothing and Calming and Repeated food exposure	Behavioral: Infant Sleeping and Soothing; Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.; Behavioral: Repeated Food Exposure; Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.
No Intervention: 4; Group receiving neither of the interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of infants sleeping 5 consecutive hours at night at 2 months of age	2.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration breastfed	2 years
Rate of weight gain	2.5 years
Self-regulation of emotion	3 years
Timing of introduction of solids	3 years
Infant dietary variety	3 years
Maternal feeding style	3 years
Infant temperament	3 years
Body Composition	3 years
Lab evaluation	5 years

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Gerber Products Company
• Investigators: Principal Investigator: Leann Birch, PhD, Penn State University; Study Director: Ian M Paul, MD, MSc, Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• Paul IM, Savage JS, Anzman SL, Beiler JS, Marini ME, Stokes JL, Birch LL. Preventing obesity during infancy: a pilot study. Obesity (Silver Spring). 2011 Feb;19(2):353-61. doi: 10.1038/oby.2010.182. Epub 2010 Aug 19.

Helpful Links

• Penn State Milton S. Hershey Children's Hospital Pediatric Clinical Research Office
• Penn State University Center for Childhood Obesity Research

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 28, 2006
• First Submitted That Met QC Criteria: July 28, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Infant Sleep; Infant Development; Infant Diet; Infant Temperament; Rapid Infant weight gain; Parenting Competence; infant weight gain
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Gain
• Other Study ID Numbers: 22165EP; Grant Number: R56DK072996