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

Primary Purpose

Weight Gain, Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Infant Sleeping and Soothing
Repeated Food Exposure
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Gain focused on measuring Infant Sleep, Infant Diet, Infant Temperament, Rapid Infant weight gain, Infant Development, Parenting Competence, infant weight gain

Eligibility Criteria

1 Day - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1

2

3

4

Arm Description

Soothing and Calming instructions given at 2 weeks of life

Repeated food exposure instructions given between 4 and 6 months of life

Receive both interventions: Soothing and Calming and Repeated food exposure

Group receiving neither of the interventions.

Outcomes

Primary Outcome Measures

Percent of infants sleeping 5 consecutive hours at night at 2 months of age

Secondary Outcome Measures

Duration breastfed
Rate of weight gain
Self-regulation of emotion
Timing of introduction of solids
Infant dietary variety
Maternal feeding style
Infant temperament
Body Composition
Lab evaluation

Full Information

First Posted
July 28, 2006
Last Updated
July 25, 2017
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Gerber Products Company
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1. Study Identification

Unique Protocol Identification Number
NCT00359242
Brief Title
The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project
Official Title
Primary Prevention of Obesity Through Infancy Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Gerber Products Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Obesity
Keywords
Infant Sleep, Infant Diet, Infant Temperament, Rapid Infant weight gain, Infant Development, Parenting Competence, infant weight gain

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Soothing and Calming instructions given at 2 weeks of life
Arm Title
2
Arm Type
Experimental
Arm Description
Repeated food exposure instructions given between 4 and 6 months of life
Arm Title
3
Arm Type
Experimental
Arm Description
Receive both interventions: Soothing and Calming and Repeated food exposure
Arm Title
4
Arm Type
No Intervention
Arm Description
Group receiving neither of the interventions.
Intervention Type
Behavioral
Intervention Name(s)
Infant Sleeping and Soothing
Intervention Description
Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.
Intervention Type
Behavioral
Intervention Name(s)
Repeated Food Exposure
Intervention Description
Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.
Primary Outcome Measure Information:
Title
Percent of infants sleeping 5 consecutive hours at night at 2 months of age
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Duration breastfed
Time Frame
2 years
Title
Rate of weight gain
Time Frame
2.5 years
Title
Self-regulation of emotion
Time Frame
3 years
Title
Timing of introduction of solids
Time Frame
3 years
Title
Infant dietary variety
Time Frame
3 years
Title
Maternal feeding style
Time Frame
3 years
Title
Infant temperament
Time Frame
3 years
Title
Body Composition
Time Frame
3 years
Title
Lab evaluation
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leann Birch, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian M Paul, MD, MSc
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20725058
Citation
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.
Results Reference
derived
Links:
URL
http://www.hmc.psu.edu/pedsclinicalresearch/index.htm
Description
Penn State Milton S. Hershey Children's Hospital Pediatric Clinical Research Office
URL
http://www.hhdev.psu.edu/ccor/
Description
Penn State University Center for Childhood Obesity Research

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

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