Clinical trial NCT00359242: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Weight Gain
Obesity
Keywords: Infant Sleep
Infant Diet
Infant Temperament
Rapid Infant weight gain
Infant Development
Parenting Competence
infant weight gain
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Gerber Products Company
First posted: 2006-08-01
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Percent of infants sleeping 5 consecutive hours at night at 2 months of age
timeFrame: 2.5 years
Secondary outcomes:
measure: Duration breastfed
timeFrame: 2 years
measure: Rate of weight gain
timeFrame: 2.5 years
measure: Self-regulation of emotion
timeFrame: 3 years
measure: Timing of introduction of solids
timeFrame: 3 years
measure: Infant dietary variety
timeFrame: 3 years
measure: Maternal feeding style
timeFrame: 3 years
measure: Infant temperament
timeFrame: 3 years
measure: Body Composition
timeFrame: 3 years
measure: Lab evaluation
timeFrame: 5 years
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Leann Birch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Milton S. Hershey Medical Center
name: Ian M Paul, MD, MSc
role: STUDY_DIRECTOR
References:
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.