Clinical trial NCT05432700: Evaluation of the Effectiveness of LactApp
Official title: Randomised Clinical Trial for Evaluation of the Effectiveness of a Mobile Application in the Improvement of Breastfeeding up to 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Keywords: Breast Feeding
Lactation
Mobile Applications
Software Validation
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 270
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Use mobile app LactApp and Breastfeeding ratio.
timeFrame: 6 months since date of birth.
Secondary outcomes:
measure: Prevalence of BF.
timeFrame: 6 months since date of birth.
measure: Reported causes of BF cessation.
timeFrame: 6 months since date of birth.
measure: Acceptability in the use of the LactApp mobile application.
timeFrame: 6 months since date of birth.
measure: HLS-EU-Q16 health literacy measurement and BF
timeFrame: 6 months since date of birth.
Other outcomes:
Locations:
city: Alzira
country: Spain
facility: Hospital La Ribera
state: Valencia
Study officials:
affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
name: Rafael Vila-Candel, PhD
role: PRINCIPAL_INVESTIGATOR
References: