Evaluation of the Effectiveness of LactApp

NCT ID: NCT05432700

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-07-31

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.

Conditions

Breast Feeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control group: usual clinical practice.

The women will receive an initial Health Literacy Survey (HLS-EU-Q16) via the email account registered on the platform. From this point until birth, no further notifications will be sent.

Subsequently, reminders will be planned via email to obtain information on BF follow-up, avoiding providing any extra information on BF and, where appropriate, referring to the BF support services available in their area, following a standard clinical practice. During pregnancy, the pregnancy programme of the local and national government provides parenting education and breastfeeding workshops, with various manuals published.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group: 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.

Group Type: EXPERIMENTAL

LactApp

Intervention Type: OTHER

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.

Interventions

LactApp

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier Soriano-Vidal

Collaborating researcher.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafael Vila-Candel, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Locations

Hospital La Ribera

Alzira, Valencia, Spain

Countries

Spain

References

Mena-Tudela D, Soriano-Vidal FJ, Vila-Candel R, Quesada JA, Aguilar L, Franco-Antonio C. Effect of Mobile-Based Counselling on Breastfeeding in Spain: A Randomized Controlled Trial Protocol (COMLACT Study). Healthcare (Basel). 2023 May 15;11(10):1434. doi: 10.3390/healthcare11101434.

Reference Type: DERIVED

PMID: 37239720 (View on PubMed)

Other Identifiers

UGP-20-100

Identifier Type: -

Identifier Source: org_study_id