Primary Prevention of Obesity Through Infancy Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Percent of infants sleeping 5 consecutive hours at night at 2 months of age
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Soothing and Calming instructions given at 2 weeks of life
Intervention: Infant Sleeping and Soothing (Behavioral)
2
Repeated food exposure instructions given between 4 and 6 months of life
Intervention: Repeated Food Exposure (Behavioral)
3
Receive both interventions: Soothing and Calming and Repeated food exposure
Intervention: Infant Sleeping and Soothing (Behavioral)
3
Receive both interventions: Soothing and Calming and Repeated food exposure
Intervention: Repeated Food Exposure (Behavioral)
4
Group receiving neither of the interventions.
Outcomes
Primary Outcomes
Percent of infants sleeping 5 consecutive hours at night at 2 months of age
Time Frame: 2.5 years
Secondary Outcomes
- Infant dietary variety(3 years)
- Duration breastfed(2 years)
- Infant temperament(3 years)
- Rate of weight gain(2.5 years)
- Timing of introduction of solids(3 years)
- Maternal feeding style(3 years)
- Lab evaluation(5 years)
- Self-regulation of emotion(3 years)
- Body Composition(3 years)
Investigators
Ian M. Paul, MD
Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics
Milton S. Hershey Medical Center