Developing Mobile Intervention of the Breast Feeding Counseling and Evaluating Its Effectiveness in Primiparous Mothers
试验速览
- 阶段
- 不适用
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Exclusive breastfeeding relative rate at 4 months of age
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of mobile intervention for breastfeeding counseling (MIBFc) to improve exclusive breastfeeding duration among primiparous women in Finland.
详细描述
The investigators hypothesize that the use of mobile intervention for breastfeeding counseling to primiparous women improve the exclusive breastfeeding rates, breastfeeding attitudes, breastfeeding confidence and the satisfaction of breastfeeding counselling. These outcomes are assumed to be higher in the intervention group than in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Statistician, who is not involved in the study has done block-randomization with variable block-sizes (2,4,6) by StatsDirect program for two groups; an intervention and control group. Maternity care staff asks informed consent and then performs the randomization of primiparous women to the intervention or control group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primiparous women
- •18 years or older
- •finnish language
- •singleton foetus
- •have an intention to breastfeed
- •have a smartphone
排除标准
- •multiple pregnancy
- •risk pregnancy, or other disease to be monitored
研究组 & 干预措施
Intervention group
In addition to standard usual care of breastfeeding counseling, the intervention group will have an opportunity to access the mobile application breastfeeding counseling from weeks 18 of pregnancy, continuing for up to 6 months after childbirth.
干预措施: Mobile intervention of breastfeeding counseling (Device)
Control group
The control group receives the standard usual care of breastfeeding counseling in maternity care and in hospital from weeks 18 of pregnancy, continuing for up to 6 months after childbirth.
The standard usual care of breastfeeding follows the 10 steps of the Baby Friendly Hospital Initiative programme and Finnish Institute for Health and Welfare recommendation.
结局指标
主要结局
Exclusive breastfeeding relative rate at 4 months of age
时间窗: 4 moths after childbirth
Proportion of infants exclusive breastfeeding at 4 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
Exclusive breastfeeding relative rate at 1 months of age
时间窗: 1 month after childbirth
Proportion of infants exclusive breastfeeding at 1 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
Exclusive breastfeeding relative rate at 6 months of age
时间窗: 6 months after childbirth
Proportion of infants exclusive breastfeeding at 6 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
次要结局
- Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)(Measurements are made in 1 and 4 months after childbirth)
- Satisfaction of breastfeeding guidance(Measurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.)
- Infants exclusive breastfeeding rate (relative share / portion)(The researcher retrieves the data from the patient record after 6 months of childbirth.)
- The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancy(Measurements are made in 18 and 34 weeks of gestation)
- Use of infants additional milk at hospital after childbirth(The researcher retrieves the data from the patient record after 6 months of childbirth.)
研究者
Pirkko Nikula
Principal Investigator
University of Oulu