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

Sponsor:	Penn State University
Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Gerber Products Company
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00359242

Purpose

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.

Condition	Intervention	Phase
Weight Gain Obesity	Behavioral: Infant Sleeping and Soothing Behavioral: Repeated Food Exposure	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Primary Prevention of Obesity Through Infancy Interventions

Resource links provided by NLM:

MedlinePlus related topics: Diets Obesity Obesity in Children

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

Percent of infants sleeping 5 consecutive hours at night at 2 months of age [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	160
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Experimental 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.
4: No Intervention Group receiving neither of the interventions.

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.

Eligibility

Ages Eligible for Study:	up to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359242

Locations

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

Sponsors and Collaborators

Penn State University

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

More Information

Additional Information:

Penn State Milton S. Hershey Children's Hospital Pediatric Clinical Research Office This link exits the ClinicalTrials.gov site

Penn State University Center for Childhood Obesity Research This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Penn State Children's Hospital, Penn State Milton S. Hershey Medical Center ( Ian M. Paul, MD, MSc )
Study ID Numbers:	22165EP, Grant Number: R56DK072996
Study First Received:	July 28, 2006
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00359242 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Infant Sleep
Infant Diet
Infant Temperament
Rapid Infant weight gain

Infant Development
Parenting Competence
infant weight gain

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Body Weight Changes

Nutrition Disorders
Overweight
Overnutrition
Weight Gain

ClinicalTrials.gov processed this record on February 08, 2010