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临床试验/NCT01536119
NCT01536119已完成不适用

Evaluating the Effectiveness of a Coparenting Breastfeeding Support Intervention on Exclusive Breastfeeding Rates at 12 Weeks Postpartum

University of Toronto2 个研究点 分布在 1 个国家目标入组 428 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
428
试验地点
2
主要终点
Exclusive Breastfeeding Rate at 12 Weeks Postpartum

研究概览

简要总结

The purpose of this trial is to evaluate the effectiveness of a Coparenting Breastfeeding Support Intervention with first time parents on exclusive breastfeeding rates at 12 weeks postpartum. Partner support and the coparenting relationship will also be evaluated.

详细描述

Breastfeeding is the recommended infant feeding method by leading health authorities. This recommendation is based on the many health benefits breastfeeding provides to both women and their infants. Breastfeeding rates in Canada, however, are suboptimal, with nearly half of mothers discontinuing exclusive breastfeeding in the first three months and less than twenty-five percent of mothers meeting the recommendation of exclusive breastfeeding to six months.

There are many factors associated with the premature cessation of exclusive breastfeeding. They include demographic, biological, psychosocial, and social factors. Some of these factors are not modifiable, such as age, social status, and education level, as they are not amenable to an intervention. One possible modifiable factor, which may assist women in overcoming breastfeeding difficulties, is fathers' support with breastfeeding. Fathers' favourable attitude and support of breastfeeding positively impacts breastfeeding initiation, duration, and exclusivity. Research on ways to assist fathers in providing support for breastfeeding is needed. The ways in which fathers can provide effective support can best be determined through intervention studies designed to increase fathers' supportive behaviour towards breastfeeding. Specifically, a coparenting framework to guide such interventions would be optimal as coparenting teaches parents to work in partnership towards positive child health outcomes. The purpose of this proposed randomized controlled trial is to evaluate the effects of a coparenting breastfeeding support intervention, delivered to primiparous breastfeeding mothers and the infants' fathers (the breastfeeding woman's male partner, who is jointly responsible for the child). It is hypothesized that this intervention will increase exclusive breastfeeding at 12 weeks postpartum. The secondary outcomes will be breastfeeding duration, perceived breastfeeding support, and coparenting at 6 and 12 weeks. Paternal breastfeeding self-efficacy and infant feeding attitude will be assessed at 6 weeks postpartum.

Participants will include first-time breastfeeding women and the infants' fathers who have singleton births and full term healthy infants. Eligible parents who consent to participate will be randomized into either the intervention group or the control group. The control group will receive standard postpartum care, which is routine care in the hospital and community related to breastfeeding. The intervention group will receive standard postpartum care, plus a multifaceted support intervention that includes: (1) a professional-based in-hospital visit in the first two days postpartum that uses a take-home workbook, breastfeeding booklet, and video, (2) two follow-up emails in the first and third week postpartum, (3) one telephone call to the mother at two weeks, and (4) access to a secure study website for a three month period. All of the components in this intervention will contain extensive information on coparenting and breastfeeding. Follow-up data will be collected by the method chosen by participants, either by web-based survey or telephone interview. This data will be collected by a research assistant blinded to group allocation and data collection points will be at 6 and 12 week postpartum.

The results of this study will be of interest to health care professionals who work with breastfeeding women and their families, as well as policy makers designing programs to meet the needs of childbearing families.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The target population for the study will be all primiparous breastfeeding women on the postpartum unit who meet the following inclusion criteria:
  • singleton birth (vaginal and cesarean births)
  • term infant (37-42 weeks gestation)
  • speaks and reads English
  • 18 years of age or older
  • parents living in the same home, father (the breastfeeding woman's male partner) jointly responsible for the infant.

排除标准

  • The exclusion criteria will include:
  • sharing a hospital room with a study participant
  • infants or maternal medical problems that interfere with breastfeeding (eg. infant with cleft palate or maternal previous breast surgery)
  • midwifery patient
  • infant not discharged home with mother
  • mother is pumping milk but not breastfeeding
  • mother does not have access to the internet
  • mother does not have a telephone.
  • father not available

结局指标

主要结局

Exclusive Breastfeeding Rate at 12 Weeks Postpartum

时间窗: 12 weeks postpartum

Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).

次要结局

  • Exclusive Breastfeeding(6 weeks)
  • Any Breastfeeding(12 weeks)
  • Coparenting Relationship(12 weeks postpartum)
  • Breastfeeding Support(12 weeks)
  • Paternal Breastfeeding Self-Efficacy(6 weeks postpartum)
  • Paternal Infant Feeding Attitude(6 weeks postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cindy-Lee Dennis

Associate Professor, Lawrence S. Bloomberg Faculty of Nursing

University of Toronto

研究点 (2)

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