- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04536896
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
438
Phase
- 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
-
-
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
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 |
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.
|
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.
|
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
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
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.
Investigators
- 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
- Brudenell I, Carpenter CS. Adult learning styles and attitudes toward computer assisted instruction. J Nurs Educ. 1990 Feb;29(2):79-83. doi: 10.3928/0148-4834-19900201-08.
- Lynch TG, Steele DJ, Johnson Palensky JE, Lacy NL, Duffy SW. Learning preferences, computer attitudes, and test performance with computer-aided instruction. Am J Surg. 2001 Apr;181(4):368-71. doi: 10.1016/s0002-9610(01)00575-x.
- Davidson LK. A 3-year experience implementing blended TBL: active instructional methods can shift student attitudes to learning. Med Teach. 2011;33(9):750-3. doi: 10.3109/0142159X.2011.558948. Epub 2011 May 19.
- Krupat E, Richards JB, Sullivan AM, Fleenor TJ Jr, Schwartzstein RM. Assessing the Effectiveness of Case-Based Collaborative Learning via Randomized Controlled Trial. Acad Med. 2016 May;91(5):723-9. doi: 10.1097/ACM.0000000000001004.
- Anjum Q, Ashfaq T, Siddiqui H. Knowledge regarding breastfeeding practices among medical students of Ziauddin University Karachi. J Pak Med Assoc. 2007 Oct;57(10):480-3.
- Freed GL, Clark SJ, Sorenson J, Lohr JA, Cefalo R, Curtis P. National assessment of physicians' breast-feeding knowledge, attitudes, training, and experience. JAMA. 1995 Feb 8;273(6):472-6. doi: 10.1001/jama.1995.03520300046035.
- Silvestre PK, Carvalhaes MA, Venancio SI, Tonete VL, Parada CM. Breastfeeding knowledge and practice of health professionals in public health care services. Rev Lat Am Enfermagem. 2009 Nov-Dec;17(6):953-60. doi: 10.1590/s0104-11692009000600005.
- de Almeida JM, Luz Sde A, Ued Fda V. [Support of breastfeeding by health professionals: integrative review of the literature]. Rev Paul Pediatr. 2015 Jul-Sep;33(3):356-63. doi: 10.1016/j.rpped.2014.10.002. Epub 2015 Jun 10.
- Arthur CR, Saenz RB, Replogle WH. Personal breast-feeding behaviors of female physicians in Mississippi. South Med J. 2003 Feb;96(2):130-5. doi: 10.1097/01.SMJ.0000051268.43410.45.
- Hall Moran V, Edwards J, Dykes F, Downe S. A systematic review of the nature of support for breast-feeding adolescent mothers. Midwifery. 2007 Jun;23(2):157-71. doi: 10.1016/j.midw.2006.06.005. Epub 2006 Oct 18.
- Dykes F. The education of health practitioners supporting breastfeeding women: time for critical reflection. Matern Child Nutr. 2006 Oct;2(4):204-16. doi: 10.1111/j.1740-8709.2006.00071.x.
- Caminha Mde F, Serva VB, dos Anjos MM, Brito RB, Lins MM, Batista Filho M. [Exclusive breastfeeding among professionals in a Family Healthcare Program]. Cien Saude Colet. 2011 Apr;16(4):2245-50. doi: 10.1590/s1413-81232011000400023. Portuguese.
- Hoddinott P, Pill R, Chalmers M. Health professionals, implementation and outcomes: reflections on a complex intervention to improve breastfeeding rates in primary care. Fam Pract. 2007 Feb;24(1):84-91. doi: 10.1093/fampra/cml061. Epub 2006 Dec 7.
- Yang SF, Salamonson Y, Burns E, Schmied V. Breastfeeding knowledge and attitudes of health professional students: a systematic review. Int Breastfeed J. 2018 Feb 20;13:8. doi: 10.1186/s13006-018-0153-1. eCollection 2018.
- Gary AJ, Birmingham EE, Jones LB. Improving breastfeeding medicine in undergraduate medical education: A student survey and extensive curriculum review with suggestions for improvement. Educ Health (Abingdon). 2017 May-Aug;30(2):163-168. doi: 10.4103/efh.EfH_180_15.
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)
July 31, 2018
Primary Completion (ACTUAL)
July 31, 2019
Study Completion (ACTUAL)
December 15, 2019
Study Registration Dates
First Submitted
August 22, 2020
First Submitted That Met QC Criteria
August 27, 2020
First Posted (ACTUAL)
September 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 3, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID 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.
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