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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Medical Education | Other: Smartphone breastfeeding application Other: Traditional face-to-face breastfeeding lecture | Not Applicable |
| 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 |
| 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. |
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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%
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
| Mexico | |
| Facultad de Medicina, Universidad Autonoma de Nuevo Leon | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Principal Investigator: | Erika Ochoa-Correa, MD | UNIVERSIDAD AUTONOMA DE NUEVO LEON, School of Medicine, Department of Pediatrics |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
breastfeeding education medical education |

