Evaluation of the Effectiveness of LactApp

Not Applicable

Completed

• Conditions: Breast Feeding
• Interventions: Other: LactApp

• Registration Number: NCT05432700
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-01-31
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-27
• Study Completion: 2022-07-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: LactApp	LactApp	From the initial registration in LactApp during the third trimester, women will be able to consult all the information available in the application. The women will receive an initial Health Literacy Survey (HLS-EU-Q16), from this point until birth, no further notifications will be sent. A reminder schedule will be made via email to obtain information on the follow-up of the BF. LactApp® works as a self-administered questionnaire based on decision trees constructed with questions and answers developed by professional breastfeeding experts, supported by scientific evidence and updated official health recommendations. In addition, the app will remind them of the topics according to the estimated date of birth provided. Surveys adapted to this group will be sent out at birth, at 15 days, 6 weeks, 3 and 6 months. The variables to be collected are socio-demographic, related to health literacy, obstetric-neonatal, and breastfeeding variables.

Primary Outcome Measures

Name	Time	Method
Use mobile app LactApp and Breastfeeding ratio.	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.

Secondary Outcome Measures

Name	Time	Method
Reported causes of BF cessation.	6 months since date of birth.	Women's reported causes of breastfeeding cessation, frequency of reported causes o breastfeeding cessation, and the length of breastfeeding up to six months postpartum.
Prevalence of BF.	6 months since date of birth.	Prevalence of breastfeeding at discharge and breastfeeding at 6 months postpartum.
Acceptability in the use of the LactApp mobile application.	6 months since date of birth.	Evaluation by the participants of the convenience, acceptability and user-friendliness of the mobile application. No personal information derived from the use of the mobile application will be collected.
HLS-EU-Q16 health literacy measurement and BF	6 months since date of birth.	HLS-EU-Q16 instrument will be used as a screening tool to evaluate the woman's health literacy level against the early cessation of BF. It assesses the health literacy level in the population through a series of 16 items measured on a Likert-type scale from "very easy" to "very difficult". It is a single-factor scale with an internal consistency of 0.982 in the Spanish population, measured by Cronbach's alpha and McDonald's omega.

Trial Locations

Locations (1)

Hospital La Ribera; 🇪🇸 Alzira, Valencia, Spain