Primary Prevention of Obesity Through Infancy Interventions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Percent of infants sleeping 5 consecutive hours at night at 2 months of age
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 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.
排除标准
- •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
研究组 & 干预措施
1
Soothing and Calming instructions given at 2 weeks of life
干预措施: Infant Sleeping and Soothing (Behavioral)
2
Repeated food exposure instructions given between 4 and 6 months of life
干预措施: Repeated Food Exposure (Behavioral)
3
Receive both interventions: Soothing and Calming and Repeated food exposure
干预措施: Infant Sleeping and Soothing (Behavioral)
3
Receive both interventions: Soothing and Calming and Repeated food exposure
干预措施: Repeated Food Exposure (Behavioral)
4
Group receiving neither of the interventions.
结局指标
主要结局
Percent of infants sleeping 5 consecutive hours at night at 2 months of age
时间窗: 2.5 years
次要结局
- Duration breastfed(2 years)
- Infant temperament(3 years)
- Rate of weight gain(2.5 years)
- Infant dietary variety(3 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)
研究者
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