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

Obesity Clinical Trial

Official title:

Primary Prevention of Obesity Through Infancy Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359242
• Other study ID #: 22165EP
• Secondary ID: Grant Number: R5
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2006
• Last updated: July 25, 2017
• Start date: June 2006
• Est. completion date: December 2009

Study information

• Verified date: July 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Gain

Intervention

Behavioral:
• Infant Sleeping and Soothing
Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.
• 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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Gerber Products Company, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of infants sleeping 5 consecutive hours at night at 2 months of age		2.5 years
Secondary	Duration breastfed		2 years
Secondary	Rate of weight gain		2.5 years
Secondary	Self-regulation of emotion		3 years
Secondary	Timing of introduction of solids		3 years
Secondary	Infant dietary variety		3 years
Secondary	Maternal feeding style		3 years
Secondary	Infant temperament		3 years
Secondary	Body Composition		3 years
Secondary	Lab evaluation		5 years

External Links

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