Smartphone Application for Breastfeeding Education in Medical Students

August 27, 2020 updated by: Erika Ochoa-Correa, Universidad Autonoma de Nuevo Leon

Efficacy of a Smartphone App for a Breastmilk Feeding Course Among Sixth Year Medical Students

The purpose of this study was to compare the efficacy of two educational interventions to enhance breastfeeding knowledge among senior medical students. One intervention consisted of a traditional face-to-face teaching lecture and the other consisted of the use of a smartphone application containing information about breastfeeding.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A quasi-experimental study was performed. Students were allocated to two groups; the first group underwent a 6-hour face-to-face breastfeeding course which was divided in four 1.5-hour sessions during a time span of two weeks. The second intervention consisted of downloading a digital smartphone application designed by the research team to teach proper breastfeeding concepts which participants freely navigated during the same time span of two weeks. Before and after each intervention, students answered a general breastfeeding knowledge test consisting of twenty multiple choice answers with a score range of 0 to 20. Statistical comparisons between pre- and post-test scores were performed in each group and mean change in scores was compared between them to establish which method was the most efficient. Moreover, amount of time spent on the application was descriptively measured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
438

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Facultad de Medicina, Universidad Autonoma de Nuevo Leon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Senior adult medical students of any gender who at the time were enrolled on the Pediatrics biannual course during the July 2018 th -July 2019 th academic period.
  • Provide verbal informed consent
  • At least 18 years old

Exclusion Criteria:

  • Students who did not possess an electronic device (smartphone or tablet) or decided not to participate in the study.
  • Rate of non-attendance to the general pediatric course greater than 50%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Traditional face-to-face teaching method
In this arm, participants underwent a 6-hour traditional face-to-face lecture on breastfeeding education in a classroom at a university. Course was divided into 4 1.5-hour sessions during a time span of two weeks.
Other: Traditional face-to-face breastfeeding lecture
This intervention consists of the impartition of a face-to-face breastfeeding course
EXPERIMENTAL: Breastfeeding smartphone app
In this group, participants downloaded a smartphone application which contained an online breastfeeding education course. Participants freely navigated through the smartphone app during a time span of two weeks.
Other: Smartphone breastfeeding application
This intervention consists of a smartphone application which contains relevant information and topics regarding proper breastfeeding knowledge for medical students.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of each breastfeeding course evaluated by a quantitative general knowledge questionnaire
Time Frame: 14 days
In order to measure this outcome, all participants answered a test consisting of a quantitative questionnaire of general breastfeeding knowledge before and after the intervention. This general knowledge test consisted of twenty questions with multiple choice answers ranging between two to five possible answers according to the nature of the question. It was designed by study researchers which included specialists in Pediatrics and breastfeeding and it was based solely on the course content. Minimum and maximum scores were 0 and 20, where a higher score indicated a better grade on the test. Central tendency and dispersion measures were obtained for pre- and post-test scores and a further statistical comparison between this parameters indicated whether there was a statistically significant difference. If the post-test score was statistically superior to the pre-test score, it was concluded that the intervention was efficient to improve breastfeeding knowledge.
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of the efficacy of each breastfeeding course by comparison of mean differences
Time Frame: 14 days
In order to measure this outcome, a mean difference between the post-test and pre-test scores was obtained for each group. Furthermore, these mean differences were compared to establish if the mean improvement in test scores was different between both interventions. If the mean change of one intervention was statistically superior to the other, it was assumed that the former intervention was more efficient to promote breastfeeding knowledge. On the contrary, if no statistical differences between the effects of both interventions on test scores were observed, it was assumed that no intervention was superior to the other.
14 days
Amount of time in minutes spent on the smartphone application
Time Frame: 14 days
Study researchers had access to the amount of time in minutes that each student dedicated to studying on the smartphone application. Descriptive statistics with central and dispersion tendencies were obtained to evaluate this outcome.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Nuevo Leon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erika Ochoa-Correa, MD, Universidad Autonoma de Nuevo Leon, School of Medicine, Department of Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PE18-00005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At request of other researchers, sharing of IPD will be assessed by the research team assuring confidentiality of participants information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Medical Education

Clinical Trials on Traditional face-to-face breastfeeding lecture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings