Randomised Clinical Trial for Evaluation of the Effectiveness of a Mobile Application in the Improvement of Breastfeeding up to 6 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Use mobile app LactApp and Breastfeeding ratio.
研究概览
简要总结
The study aims to determine the influence of an intervention in women based on a free mobile application (LactApp®) on maintaining breastfeeding (BF) up to 6 months postpartum. This is an experimental, multicentre, prospective study with a control group comparing the duration of BF. It will be carried out in the Health Departments of La Ribera, Xàtiva-Ontinyent, Castelló and Extremadura in 2021, 2022 and 2023. Women will be randomly assigned to each of the parallel groups. In the control group, the usual clinical practice will be followed from the third trimester of gestation to promote BF. In the intervention group, the woman, in addition to the usual clinical practice, will use a free mobile app: LactApp®, from the third trimester until 6 months postpartum. The type of breastfeeding at birth, 15 days, 3 and 6 months postpartum, and the causes of cessation of BF in both groups will be monitored. Socio-demographic data and the woman's reported outcomes will be collected during the pregnancy, birth, and postpartum process. The mobile app will report data on use, topics consulted and usage times. The null hypothesis is that the ¨LactApp®¨ mobile application does not improve breastfeeding maintenance at 6 months postpartum compared to routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who show a desire to breastfeed during the third trimester of pregnancy, with a command of Spanish, and whose birth will occur in one of the participating hospitals.
排除标准
- •Not having a mobile device with an internet connection.
- •Newborns of less than 37 weeks of gestation or with congenital malformations. malformations.
- •Twin or multiple pregnancies, pregnancies admitted to neonatal care, or postpartum complications result in the mother being admitted to the intensive care unit.
- •Women who do not respond respond to the automatic messages provided by the platform.
- •In the intervention group, the non-installation of the mobile app Lactapp® mobile application.
- •Women who have used the Lactapp® application on their own initiative will be excluded from the control group.
结局指标
主要结局
Use mobile app LactApp and Breastfeeding ratio.
时间窗: 6 months since date of birth.
Rate of breastfeeding at 6 months postpartum for women who have used the mobile app LactApp compared with women in routine care arm.
次要结局
- Reported causes of BF cessation.(6 months since date of birth.)
- Prevalence of BF.(6 months since date of birth.)
- Acceptability in the use of the LactApp mobile application.(6 months since date of birth.)
- HLS-EU-Q16 health literacy measurement and BF(6 months since date of birth.)
研究者
Francisco Javier Soriano-Vidal
Collaborating researcher.
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana