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Breast FeedingCOMLACTNCT05432700

Evaluation of the Effectiveness of LactApp

A study testing LactApp in people with Breast Feeding, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 99 years, women only
Conditions the study is for
Breast Feeding
What is being tested?
LactApp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteSpain
Study dates
1 Feb 2021to 31 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 99 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital La Ribera

    Alzira, Valencia, 46600

Other trials in Spain

About this study

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

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
Being tested
LactApp
Keywords
Breast Feeding, Lactation, Mobile Applications, Software Validation
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LactAppOther

    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.

Study groups in NCT05432700
Study groupRoleWhat they receive
Control group: usual clinical practice.No interventionThe 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.
Intervention group: LactAppExperimentalFrom 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.
Receives: Other: LactApp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months since date of birth.

Secondary outcomes (4)

  1. Prevalence of BF.

    Prevalence of breastfeeding at discharge and breastfeeding at 6 months postpartum.

    Measured: 6 months since date of birth.

  2. 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.

    Measured: 6 months since date of birth.

  3. 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.

    Measured: 6 months since date of birth.

  4. 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.

    Measured: 6 months since date of birth.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start1 Feb 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05432700
Sponsor's protocol ID
UGP-20-100
Acronym
COMLACT
Status last verified
Jun 2023
First submitted
3 May 2022
Last updated
29 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Aranda-Reneo I, Candel RV, Mena-Tudela D, Santacruz-Salas E. Cost-utility and cost-effectiveness analysis of an AI-driven platform for standard postnatal care and breastfeeding: results from the COMLACT study. Eur J Health Econ. 2026 Sep 16. doi: 10.1007/s10198-026-01951-2. Online ahead of print.

    PubMed 42747733

  • 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.

    PubMed 37239720

Questions about this trial

What is this clinical trial studying?

A study testing LactApp in people with Breast Feeding, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Use mobile app LactApp and Breastfeeding ratio. (time frame: 6 months since date of birth.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05432700, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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