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临床试验/NCT00222118
NCT00222118已完成不适用

Promoting and Supporting Breastfeeding in Adolescents

University of Kansas2 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2003年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
390
试验地点
2
主要终点
Primary outcome is breastfeeding initiation at hospital discharge.

研究概览

简要总结

Breastfeeding initiation and duration in adolescent mothers.

详细描述

Randomized clinical trial to test the effects of a comprehensive prenatal, in-hospital, and postpartum education and support intervention on breastfeeding initiation and duration among teenage mothers. Experimental, attention control, and usual care groups are used to test the hypotheses. Drawing on the Theory of Planned Behavior and begun during the second trimester of pregnancy, the experimental condition uses a lactation consultant-peer counselor team to influence pregnant adolescents' beliefs and intentions about breastfeeding their newborns. The attention control (placebo) condition mimics the experimental condition, using an advanced practice nurse and peer counselor intervention team, and focuses on healthy pregnancy behaviors and labor/birth preparation. Teens in the two intervention groups attend two prenatal classes specific to their focus between the fourth and ninth month of pregnancy and receive telephone calls from a peer counselor. Teens in a usual care group receive no interventions beyond their standard prenatal care and education. After giving birth and still in the hospital, teens in the intervention groups receive a peer counselor phone call and visit. Breastfeeding teens in the experimental group also receive a breastfeeding counselor visit. After hospital discharge, breastfeeding teens from both intervention groups continue to receive peer counselor telephone support and, in the experimental condition, breastfeeding counselor phone calls for four weeks. Breastfeeding teens from all three groups complete short telephone interviews until six months after birth or until they stop breastfeeding.

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
15 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 15-18 years
  • Adolescents intending to keep their newborns
  • 14 to 27 weeks of gestation
  • Ability to speak and read English
  • Possession or access to a telephone for study contact

排除标准

  • Multiple gestation pregnancy
  • Premature birth
  • Infant with cleft lip/palate, congenital heart defects, Down Syndrome, neural tube defects, or other conditions warranting the newborn's admission to neonatal intensive care
  • Subjects treated for significant complications during labor and birth that prohibit or delay breastfeeding beyond 48 hours or that have other conditions for which breastfeeding is contraindicated (e.g. HIV)

研究组 & 干预措施

1

Experimental

intervention group

干预措施: intervention (Other)

2

Other

Attention control

干预措施: labor/birth preparation classes (Behavioral)

3

Other

Usual care

干预措施: usual care (Other)

结局指标

主要结局

Primary outcome is breastfeeding initiation at hospital discharge.

时间窗: hospital discharge

次要结局

  • Breastfeeding duration (in days) at 6 months postpartum(6 months postpartum)
  • Knowledge, attitudes, subjective norms, perceived behavioral control, and intentions regarding infant feeding prenatally(at enrollment, 36 weeks of gestation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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