Evaluation of the Effectiveness of LactApp

Breast Feeding Clinical Trial

— COMLACT  

Official title:

Randomised Clinical Trial for Evaluation of the Effectiveness of a Mobile Application in the Improvement of Breastfeeding up to 6 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432700
• Other study ID #: UGP-20-100
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: June 2023
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital La Ribera	Alzira	Valencia

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use mobile app LactApp and Breastfeeding ratio.	Rate of breastfeeding at 6 months postpartum for women who have used the mobile app LactApp compared with women in routine care arm.	6 months since date of birth.
Secondary	Prevalence of BF.	Prevalence of breastfeeding at discharge and breastfeeding at 6 months postpartum.	6 months since date of birth.
Secondary	Reported causes of BF cessation.	Women's reported causes of breastfeeding cessation, frequency of reported causes o breastfeeding cessation, and the length of breastfeeding up to six months postpartum.	6 months since date of birth.
Secondary	Acceptability in the use of the LactApp mobile application.	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.	6 months since date of birth.
Secondary	HLS-EU-Q16 health literacy measurement and BF	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.	6 months since date of birth.