Sleep-Safe: a Strong African American Families Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Change in infants' weight for age from 3 weeks to 16 weeks (conditional weight gain)
研究概览
简要总结
Rapid weight gain during infancy is a powerful, and potentially malleable, risk factor for later overweight and obesity, but limited research has examined the impact of promising interventions when applied to the groups most at risk for rapid weight gain in infancy. The present study examines whether providing mothers of newborns with responsive parenting guidance during the first weeks of life to promote infant sleep and soothing can reduce rapid weight gain for African American infants born in low SES contexts.
详细描述
The study design is a randomized controlled trial. This trial will deliver a responsive parenting intervention (Sleep Soothe) to provide information on how to soothe, how to distinguish hunger from other distress, how to promote self-soothing, and bedtime routines. The responsive parenting intervention will be compared to a safety control group (Sleep Safe). The programs will be delivered across 2 sessions at 3-weeks and 8-weeks postpartum. Both interventions and all data collection will be delivered in participants' homes. Assessments will be conducted in participants' homes at 1-week postpartum, 3 weeks postpartum, 8 weeks postpartum, and 16-weeks postpartum.
Three hundred African American infants and their mothers will be recruited from the mother/baby nursery at Augusta University Medical Center. A dedicated recruitment coordinator will have access to electronic medical records systems in order to pre-screen mothers and infants. The recruitment coordinator will approach those who match basic inclusion criteria and will deliver an approved verbal script to pre-screened mothers to determine interest in participation. Interested mothers will respond to remaining screening questions in order to confirm eligibility. Once enrollment criteria are satisfied, informed consent will be obtained from the infant's mother during her hospital stay. Mothers will also complete selected demographic information. Anthropometric measurements will be obtained on the infant, mother, and father (optional). After enrollment, families will be scheduled for a research visit at their home at 1 week postpartum.
At home visit 1 (7-10 days postpartum), mothers (and fathers, if interested) will complete questionnaire measures using Qualtrics. There will also be measurements of infant weight and length. Families will be randomized to condition following this visit.
At home visit 2 (3 weeks postpartum), families will receive either the responsive parenting intervention or the safety control intervention. They will complete brief questionnaires. Measures of infant, maternal, and paternal (optional) weight will be obtained.
At home visit 3 (8 weeks postpartum), families will receive either the second part of the responsive parenting intervention or the second part of the safety control intervention. They will complete brief questionnaires. Measures of infant, maternal, and (optional: paternal) weight will be obtained. Mothers will be provided with activity monitors for themselves and for their babies that will be picked up by study staff after 7 days' use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant > 37 0/7 weeks gestational age, apparently healthy and without significant morbidity
- •Singleton infant
- •Nursery/NICU/maternity stay of 7 days or less
- •Mother at least 17 years of age
- •Mother self-identifies as African American
- •Mother is primiparous
排除标准
- •Non-English speaking
- •Infant birth weight <2500 grams
- •Presence of a congenital anomaly or neonatal physical or metabolic condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
- •Any major maternal morbidities, pre-existing condition that would affect postpartum care or her ability to care for her newborn (e.g., narcotic drug use: heroin, cocaine, meth, pain pills, etc; on chemotherapy; uncontrolled MS; uncontrolled depression causing social service contact).
- •Plan for newborn to be adopted
- •Plan to move from area within four months of delivery
- •Residence further than 75 miles from Augusta, GA
结局指标
主要结局
Change in infants' weight for age from 3 weeks to 16 weeks (conditional weight gain)
时间窗: 3 weeks to 16 weeks
Standardized residuals from the linear regression of weight for age at 16 weeks on weight for age at 3 weeks, with length for age at birth and 16 weeks and infant age at the 16-week assessment entered as covariates
次要结局
- Change in infants' weight for age(3 weeks to 16 weeks)
- Weight-for-age z scores(16 weeks)
- Weight-for-length z scores(16 weeks)
- Infant BMI z scores(16 weeks)
研究者
Justin Lavner
Associate Professor
University of Georgia