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

This study has been completed.
Sponsor:
Collaborators:
Gerber Products Company
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00359242
First received: July 28, 2006
Last updated: March 9, 2011
Last verified: November 2008

July 28, 2006
March 9, 2011
June 2006
November 2008   (final data collection date for primary outcome measure)
Percent of infants sleeping 5 consecutive hours at night at 2 months of age [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Percent of infants sleeping 5 consecutive hours at night at 2 months of age
Complete list of historical versions of study NCT00359242 on ClinicalTrials.gov Archive Site
  • Duration breastfed [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rate of weight gain [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Self-regulation of emotion [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Timing of introduction of solids [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Infant dietary variety [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Maternal feeding style [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Infant temperament [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Lab evaluation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration breastfed
  • Rate of weight gain
  • Self-regulation of emotion
  • Timing of introduction of solids
  • Infant dietary variety
  • Maternal feeding style
  • Infant temperament
  • Bioelectric impedance analysis
  • Lab evaluation
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Weight Gain
  • Obesity
  • 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.
  • Experimental: 1
    Soothing and Calming instructions given at 2 weeks of life
    Intervention: Behavioral: Infant Sleeping and Soothing
  • Experimental: 2
    Repeated food exposure instructions given between 4 and 6 months of life
    Intervention: Behavioral: Repeated Food Exposure
  • Experimental: 3
    Receive both interventions: Soothing and Calming and Repeated food exposure
    Interventions:
    • Behavioral: Infant Sleeping and Soothing
    • Behavioral: Repeated Food Exposure
  • No Intervention: 4
    Group receiving neither of the interventions.
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. Epub 2010 Aug 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
December 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
up to 12 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00359242
22165EP, Grant Number: R56DK072996
Not Provided
Ian M. Paul, MD, MSc, Penn State Children's Hospital, Penn State Milton S. Hershey Medical Center
Penn State University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Gerber Products Company
Principal Investigator: Leann Birch, PhD Penn State University
Study Director: Ian M Paul, MD, MSc Milton S. Hershey Medical Center
Penn State University
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP