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临床试验/NCT01272661
NCT01272661已完成不适用

Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers in Cleveland

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家目标入组 1,296 人开始时间: 2011年6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
1,296
试验地点
2
主要终点
Program Feasibility- Feeding Outcome Collected

研究概览

简要总结

Breast for Success is a new direct service program focused on overcoming barriers to breastfeeding for low-income inner-city mothers by use of a culturally competent and home-based educational and support intervention. Key project components include a new Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and two innovative support plans, the Breastfeeding Doula and Father Support Programs. The objective is to increase breastfeeding rates for high-risk inner-city mothers.

Research Questions to evaluate project feasibility and effectiveness are:

  1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
  2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
  3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?
  4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?

详细描述

Low rates of breastfeeding among low-income inner-city mothers represent a challenging health disparity that adversely impacts child and maternal health. The overall objective of Breast for Success is to increase the rates of breastfeeding initiation, continuation and exclusivity among high-risk mothers in the City of Cleveland via home-based culturally appropriate interventions. Key project components include a new Curriculum with brief engaging modules utilizing games, teach-reteach strategies, and interactive learning to address specific barriers identified in focus groups (e.g. pain, low milk supply, breast "myths"), and two innovative support components, the Breastfeeding Doula and Father Support Programs. Breast for Success was developed in collaboration with and will be disseminated in partnership with the Cleveland Department of Public Health MomsFirst initiative (a Healthy Start Program), which delivers comprehensive services including twice-monthly Community Health Worker home visits prenatally through 2 years postpartum to 500 women annually. The investigators will measure program success via participation logs, satisfaction questionnaires and breastfeeding rates at 1, 3 and 6 months postpartum.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant woman enrolled in MomsFirst Program of Greater Cleveland

排除标准

  • incarceration
  • Other study populations include the Community Health Workers, the doulas and the fathers of the study mothers.

结局指标

主要结局

Program Feasibility- Feeding Outcome Collected

时间窗: by 24 months

Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome

Program Feasibility - Curriculum Modules

时间窗: by 24 months from program start

Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11

次要结局

  • Breastfeeding Rate at One Month Postpartum(Any and exclusive breastfeeding at one month, between 21-38 days postpartum)
  • Breastfeeding Rate at 3 Months Postpartum(Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum)
  • Breastfeeding Rate(Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours)
  • Breastfeeding Rate at 6 Months Postpartum(Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum)

研究者

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

Lydia Furman

Associate Professor of Pediatrics

University Hospitals Cleveland Medical Center

研究点 (2)

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