Evaluation of the Effectiveness of LactApp
Condition: Breast Feeding
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): LactApp
Intervention type(s): Other
Intervention description(s): LactApp® provides personalised answers that can be arrived at through different pathways, which vary according to the profile of the user and the options she selects, allowing data sampling through an Ecological Momentary Assessment.
The app will remind of:
The first month: baby's breastfeeding position, frequency of feeds, number and consistency of stools, general breast care, average weight gain; in mothers who gave some supplementation, advice and support for them to try re-breastfeeding.
From the second to the third month: advice on expressing milk to create a reserve just in case they went back to work or had to be absent from home for a day, instructions on how to handle and preserve milk.
From the fourth to the sixth month: indications to use the stored milk (if it was created) and techniques for administering it to the infant, the importance of maintaining the EBF and the inadvisability of offering other types of milk or food.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After reading the patient information sheet and accepting the informed consent, they will be registered on the Breastfeeding Study web platform and included in one of the groups (intervention/control) through a randomisation process. Women will be selected during the third trimester of pregnancy at the surgery and during the midwifery routine care in each health department. Women in the intervention group will be provided with information on how to download the free LactApp® app for iOS and Android.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Breast Feeding; Lactation; Mobile Applications; Software Validation