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Smartphone Application for Breastfeeding Education in Medical Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04536896
Recruitment Status : Completed
First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Erika Ochoa-Correa, Universidad Autonoma de Nuevo Leon

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Medical Education Other: Smartphone breastfeeding application Other: Traditional face-to-face breastfeeding lecture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-randomized quasi-experimental trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Efficacy of a Smartphone App for a Breastmilk Feeding Course Among Sixth Year Medical Students
Actual Study Start Date : July 31, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536896


Locations
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Mexico
Facultad de Medicina, Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Erika Ochoa-Correa, MD UNIVERSIDAD AUTONOMA DE NUEVO LEON, School of Medicine, Department of Pediatrics
Publications:

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Responsible Party: Erika Ochoa-Correa, Medical Doctor, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT04536896    
Other Study ID Numbers: PE18-00005
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At request of other researchers, sharing of IPD will be assessed by the research team assuring confidentiality of participants information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erika Ochoa-Correa, Universidad Autonoma de Nuevo Leon:
breastfeeding education
medical education