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

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ClinicalTrials.gov Identifier: NCT00359242
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : July 28, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gerber Products Company
Information provided by (Responsible Party):
Ian M. Paul, MD, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE July 28, 2006
First Posted Date  ICMJE August 1, 2006
Last Update Posted Date July 28, 2017
Study Start Date  ICMJE June 2006
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2007)
Percent of infants sleeping 5 consecutive hours at night at 2 months of age [ Time Frame: 2.5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2006)
Percent of infants sleeping 5 consecutive hours at night at 2 months of age
Change History Complete list of historical versions of study NCT00359242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2007)
  • Duration breastfed [ Time Frame: 2 years ]
  • Rate of weight gain [ Time Frame: 2.5 years ]
  • Self-regulation of emotion [ Time Frame: 3 years ]
  • Timing of introduction of solids [ Time Frame: 3 years ]
  • Infant dietary variety [ Time Frame: 3 years ]
  • Maternal feeding style [ Time Frame: 3 years ]
  • Infant temperament [ Time Frame: 3 years ]
  • Body Composition [ Time Frame: 3 years ]
  • Lab evaluation [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project
Official Title  ICMJE Primary Prevention of Obesity Through Infancy Interventions
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Weight Gain
  • Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2006)
160
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359242
Other Study ID Numbers  ICMJE 22165EP
Grant Number: R56DK072996
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ian M. Paul, MD, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Gerber Products Company
Investigators  ICMJE
Principal Investigator: Leann Birch, PhD Penn State University
Study Director: Ian M Paul, MD, MSc Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date July 2017

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