Medical EducationNCT04536896

Smartphone Application for Breastfeeding Education in Medical Students

A study testing Smartphone breastfeeding application and Traditional face-to-face breastfeeding lecture in people with Medical Education, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Medical Education
What is being tested?: Smartphone breastfeeding application and Traditional face-to-face breastfeeding lecture
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 438 participants
Where: 1 siteMexico
Study dates: 31 Jul 2018to 15 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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%

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Facultad de Medicina, Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

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

Read the 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.

Conditions: Medical Education
Being tested: Smartphone breastfeeding application, Traditional face-to-face breastfeeding lecture
Keywords: breastfeeding education, medical education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Smartphone breastfeeding applicationOther
This intervention consists of a smartphone application which contains relevant information and topics regarding proper breastfeeding knowledge for medical students.
Traditional face-to-face breastfeeding lectureOther
This intervention consists of the impartition of a face-to-face breastfeeding course

Study groups in NCT04536896
Study group	Role	What they receive
Traditional face-to-face teaching method	Active comparator	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. Receives: Other: Traditional face-to-face breastfeeding lecture
Breastfeeding smartphone app	Experimental	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. Receives: Other: Smartphone breastfeeding application

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of each breastfeeding course evaluated by a quantitative general knowledge questionnaire
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.
Measured: 14 days

Secondary outcomes (2)

Comparison of the efficacy of each breastfeeding course by comparison of mean differences
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.
Measured: 14 days
Amount of time in minutes spent on the smartphone application
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.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 201815 Dec 2019

First posted3 Sep 2020
Study start31 Jul 2018
Primary completion31 Jul 2019
Study completion15 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Medical EducationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Non-randomized quasi-experimental trial
Masking: None (open label)
Enrolment: 438 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04536896
Sponsor's protocol ID: PE18-00005
Status last verified: Aug 2020
First submitted: 22 Aug 2020
Last updated: 3 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: At request of other researchers, sharing of IPD will be assessed by the research team assuring confidentiality of participants information.

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.
PubMed 2154567
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.
PubMed 11438276
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.
PubMed 21592018
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.
PubMed 26606719
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.
PubMed 17990420
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.
PubMed 7837365
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.
PubMed 20126936
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.
PubMed 26141902
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.
PubMed 12630635
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.
PubMed 17052824
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.
PubMed 16999766
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.
PubMed 21584465
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.
PubMed 17158185
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.
PubMed 29483935
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.
PubMed 28928347

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of a Smartphone App for a Breastmilk Feeding Course Among Sixth Year Medical Students
ClinicalTrials.gov ID: NCT04536896
Acronym / sponsor ID: PE18-00005
Conditions: Medical Education
Keywords: breastfeeding education, medical education
Study type: Interventional
Recruitment status: Completed
Enrolment: 438 participants (actual)
Lead sponsor: Universidad Autonoma de Nuevo LeonUniversity, hospital or other
Study start: 31 Jul 2018 (actual)
Primary completion: 31 Jul 2019 (actual)
Study completion: 15 Dec 2019 (actual)
First posted: 3 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Non-randomized quasi-experimental trial

Arm	Type	Receives
Traditional face-to-face teaching method	Active comparator	Other: Traditional face-to-face breastfeeding lectureIn 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.
Breastfeeding smartphone app	Experimental	Other: Smartphone breastfeeding applicationIn 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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%

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Smartphone breastfeeding applicationThis intervention consists of a smartphone application which contains relevant information and topics regarding proper breastfeeding knowledge for medical students.	Other	Breastfeeding smartphone app
Traditional face-to-face breastfeeding lectureThis intervention consists of the impartition of a face-to-face breastfeeding course	Other	Traditional face-to-face teaching method

Primary outcome

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.

2 secondary outcomes

Comparison of the efficacy of each breastfeeding course by comparison of mean differences
Time frame: 14 days
Amount of time in minutes spent on the smartphone application
Time frame: 14 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
Background: PubMed 2154567Brudenell 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.
Background: PubMed 11438276Lynch 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.
Background: PubMed 21592018Davidson 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.
Background: PubMed 26606719Krupat 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.
Background: PubMed 17990420Anjum 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.
Background: PubMed 7837365Freed 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.
Background: PubMed 20126936Silvestre 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.
Background: PubMed 26141902de 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.
Background: PubMed 12630635Arthur 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.
Background: PubMed 17052824Hall 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.
Background: PubMed 16999766Dykes 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.
Background: PubMed 21584465Caminha 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.
Individual participant dataSharing planned: No. At request of other researchers, sharing of IPD will be assessed by the research team assuring confidentiality of participants information.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erika Ochoa-Correa, MD principal investigator

UNIVERSIDAD AUTONOMA DE NUEVO LEON, School of Medicine, Department of Pediatrics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of each breastfeeding course evaluated by a quantitative general knowledge questionnaire (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04536896, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.