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Evaluation of the Effectiveness of LactApp

NCT05432700 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2023-06-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Rafael Vila-Candel, PhD · Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-01-31
Completion
2022-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05432700 on ClinicalTrials.gov