BreastfeedingNCT04705675
The Impact of Breastfeeding Education on Breastfeeding Behavior and the Use of Traditional Practices
A study testing Breastfeeding Education in people with Breastfeeding and Breasfeeding Traditional Practices, run by Aysegul Durmaz at 1 site in Turkey (Türkiye).
Trial summary
H1a: The breastfeeding education has an effect the behaviors of mothers toward breastfeeding. H1b: The breastfeeding education has an effect on the use of traditional breastfeeding practices. H0a: The breastfeeding education has not an effect the behaviors of mothers toward breastfeeding. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breasfeeding Traditional Practices, Post Procedural Discharge
- What is being tested?
- Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 31 Oct 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To receive breasfeeding education
- To have singleton birth or one infant
- Not have complications postpartum period
- Not have chronic diseases or mental disorders
- Older than 18 years
- To voluntary to participate
Show all 10Show fewer
- To know how to read, write and speak in Turkish
- To stay within this study until the end
- To have a newborn with no complications
- To have a 0-6 months healthy infants
Who cannot join
- Not receive breasfeeding education
- Having multiple birth or more than a baby
- Having complications postpartum period
- Having chronic diseases or mental disorders
- Younger than 18 years
- To refuse to participate
Show all 11Show fewer
- Not knowing how to read, write and speak Turkish
- To leave early this study
- Having a newborn with complications
- Having a baby in need of medical care
- To have a older than 0-6 months infants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Science University
Kütahya, 43000
About this study
Official title: The Impact of Breastfeeding Education on Breastfeeding Behavior and the Use of Traditional Practices (An Example From Turkey): A Randomized Controlled Trial
H1a: The breastfeeding education has an effect the behaviors of mothers toward breastfeeding.
H1b: The breastfeeding education has an effect on the use of traditional breastfeeding practices.
H0a: The breastfeeding education has not an effect the behaviors of mothers toward breastfeeding.
H0b: The breastfeeding education has not an effect on the use of traditional breastfeeding practices.
Read the detailed description
The study was designed to be parallel group, randomized controlled study (1:1). The study universe consisted of all of the mothers presenting at the family health centers (FHC's) of a province in Turkey over the period February 1, 2018-October 31, 2018.
The study samples were included 152 study and 152 control group which individuals selected by simple random sampling.In the power analysis performed at a confidence interval of 95% and a margin of error of plus/minus 5%, sample size was calculated as a total of 304 mothers with 152 in the study group and 152 in the control group.
The researchers collected the data for the study. They administered the pretest and filled out the personal information form prior to the planned individual education. The mothers were asked to remember the pseudonyms they used on the pretest and to use the same pseudonym on the posttest. Following the pretest, the mothers in the study group were taken into a separate room at the FHC and asked to breastfeed their infants. The mothers' breastfeeding behaviors were observed. After the breastfeeding, each mother was provided an average 30-minute session of individual education. All of the mothers in the study group received the education from the same researcher. Both audio and visual materials were used in the mothers' training. The researchers educated the mothers on breastfeeding techniques in an effort to encourage them to develop the skill of correctly using the positions taught and then the mothers were asked to practice what they had learned. The researcher took care to be positive and support whenever the mother attempted the right move in breastfeeding while also providing encouraging feedback when something went wrong. Included in the content of the education were the topics of the formation of breast milk and its benefits, the duration of breastfeeding, the sufficiency of breast milk, factors that reduced and increased it, things to look out for before breastfeeding, taking the right position for breastfeeding and positioning the baby on the breast, the steps in breastfeeding, burping the baby afterwards, milking and storing the mother's milk, and other issues that could pose problems during breastfeeding (Turkish Ministry of Health Basic Health Services General Directorate 2008). To test the retention of what was learned in the training, a posttest was administered to the groups one month following the education.
The Personal Information Form and the Breastfeeding Behaviors and Traditional Practices Assessment Form were used as data collection tools.
Statistical analyses were performed using IBM SPSS (Statistical Package for Social Sciences) Statistics 22 software. Descriptive statistics (means, standard deviation, frequencies and percentages) were used in the analysis of the findings. Normality tests (Kolmogorov-Smirnov Test) were performed on all continuous variables.
- Being tested
- Breastfeeding Education
- Keywords
- Breastfeeding, Education, Behavior, Traditional practices
- Medical subject headings
- Breast Feeding, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding EducationBehavioural
The mothers were asked to remember the pseudonyms they used on the pretest and to use the same pseudonym on the posttest. Following the pretest, the mothers in the study group were taken into a separate room at the FHC and asked to breastfeed their infants. The mothers' breastfeeding behaviors were observed. After the breastfeeding, each mother was provided an average 30-minute session of individual education. All of the mothers in the study group received the education from the same researcher. Both audio and visual materials were used in the mothers' training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The mothers in the experimental group (152) were administered. Receives: Behavioral: Breastfeeding Education |
| Control Group | No intervention | The mothers in the control group (152) were administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Education Mothers' traditional breastfeeding practices
The Breastfeeding Behaviors Form was created in line with the literature. The questionnaires were filled out by the researchers using the face-to-face interview method. The questionnaire for Breastfeeding Behaviors included the following questions: Education about mother's milk and breastfeeding, When did you first breastfeed your baby after birth? Have you given your baby the first milk from your breast? Has your baby been given any food other than breast milk after birth? Why are you giving other food to your baby? Have you continued to feed your baby any other food? Do you give your baby water after breastfeeding? Breastfeeding Length (Daily)-Frequency (Daily)-Position-Latching, Having Problems with Breastfeeding, b. How long do you intend to breastfeed your baby?
Measured: 20 minute after the admittance to the family health centers
Pre-Education Breastfeeding behavior
Traditional Practices Assessment Form was created in line with the literature. The questionnaires were filled out by the researchers using the face-to-face interview method. The Mother's Traditional Breastfeeding Practices Assessment Form included the following questions: Are there any traditional practices you use for breastfeeding? Do you think the traditional Practices you use for breastfeeding are useful? Who suggested traditional practices regarding breastfeeding? Do you voluntarily use traditional breastfeeding practices? Are There Foods You Consume to Increase Breast Milk? Who recommended the foods you consume to increase breast milk? Do you think the Food You Consume to Increase Breast Milk is beneficial? Do you voluntarily consume the foods you consume to increase breast milk?
Measured: 20 minute after the admittance to the family health centers
Secondary outcomes (2)
Post-Education
The Breastfeeding Behaviors Form was created in line with the literature. The questionnaires were filled out by the researchers using the face-to-face interview method. The questionnaire for Breastfeeding Behaviors included the following questions: How are you feeding your baby now? Has your baby been given any food other than breast milk after birth? Breastfeeding Length (Daily)-Frequency (Daily)-Position-Latching, Having Problems with Breastfeeding, What do you pay attention to avoid cracked nipples in your breast? Why are you giving other food to your baby? Do you give your baby water after breastfeeding? How long do you intend to breastfeed your baby? Does your partner support your breastfeeding?
Measured: 1 month following the breastfeeding education.
Post-Education
Traditional Practices Assessment Form was created in line with the literature. The questionnaires were filled out by the researchers using the face-to-face interview method. The Mother's Traditional Breastfeeding Practices Assessment Form included the following questions: Are there any traditional practices you use for breastfeeding? Do you think the traditional Practices you use for breastfeeding are useful? Who suggested traditional practices regarding breastfeeding? Do you voluntarily use traditional breastfeeding practices? Are There Foods You Consume to Increase Breast Milk? Who recommended the foods you consume to increase breast milk? Do you think the Food You Consume to Increase Breast Milk is beneficial? Do you voluntarily consume the foods you consume to increase breast milk?
Measured: 1 month following the breasfeeding education.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Feb 2018
- Primary completion4 Jun 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed to be parallel group, randomized controlled study (1:1). Power was calculated using the GPower 3.1 program. In the power analysis performed at a confidence interval of 95% and a margin of error of plus/minus 5%, sample size was calculated as a total of 304 mothers with 152 in the study group and 152 in the control group.A total of 304 mothers were evenly and homogeneously assigned to both groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysegul Durmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysegul Durmaz, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705675
- Sponsor's protocol ID
- Breas. Trad. Pra.
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Zielinska MA, Sobczak A, Hamulka J. Breastfeeding knowledge and exclusive breastfeeding of infants in first six months of life. Rocz Panstw Zakl Hig. 2017;68(1):51-59.
PubMed 28303701Bellu R, Condo M. Breastfeeding promotion: evidence and problems. Pediatr Med Chir. 2017 Jun 28;39(2):156. doi: 10.4081/pmc.2017.156.
PubMed 28673077Huang P, Yao J, Liu X, Luo B. Individualized intervention to improve rates of exclusive breastfeeding: A randomised controlled trial. Medicine (Baltimore). 2019 Nov;98(47):e17822. doi: 10.1097/MD.0000000000017822.
PubMed 31764775Sharma A. Efficacy of early skin-to-skin contact on the rate of exclusive breastfeeding in term neonates: a randomized controlled trial. Afr Health Sci. 2016 Sep;16(3):790-797. doi: 10.4314/ahs.v16i3.20.
PubMed 27917213Sandoval Jurado L, Jimenez Baez MV, Olivares Juarez S, de la Cruz Olvera T. [Breastfeeding, complementary feeding and risk of childhood obesity]. Aten Primaria. 2016 Nov;48(9):572-578. doi: 10.1016/j.aprim.2015.10.004. Epub 2016 Feb 12. Spanish.
PubMed 26880166McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD001141. doi: 10.1002/14651858.CD001141.pub5.
PubMed 28244064Hay G, Baerug AB. The benefits of exclusive breastfeeding up to six months. Tidsskr Nor Laegeforen. 2019 May 3;139(9). doi: 10.4045/tidsskr.19.0105. Print 2019 May 28. No abstract available. English, Norwegian.
PubMed 31140258Del Ciampo LA, Del Ciampo IRL. Breastfeeding and the Benefits of Lactation for Women's Health. Rev Bras Ginecol Obstet. 2018 Jun;40(6):354-359. doi: 10.1055/s-0038-1657766. Epub 2018 Jul 6.
PubMed 29980160
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Breastfeeding Education on Breastfeeding Behavior and the Use of Traditional Practices (An Example From Turkey): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04705675
- Acronym / sponsor ID
- Breas. Trad. Pra.
- Keywords
- Breastfeeding, Education, Behavior, Traditional practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Aysegul DurmazUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 12 Jan 2021 (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.
H1a: The breastfeeding education has an effect the behaviors of mothers toward breastfeeding.
H1b: The breastfeeding education has an effect on the use of traditional breastfeeding practices.
H0a: The breastfeeding education has not an effect the behaviors of mothers toward breastfeeding.
H0b: The breastfeeding education has not an effect on the use of traditional breastfeeding practices.
Detailed description
The study was designed to be parallel group, randomized controlled study (1:1). The study universe consisted of all of the mothers presenting at the family health centers (FHC's) of a province in Turkey over the period February 1, 2018-October 31, 2018.
The study samples were included 152 study and 152 control group which individuals selected by simple random sampling.In the power analysis performed at a confidence interval of 95% and a margin of error of plus/minus 5%, sample size was calculated as a total of 304 mothers with 152 in the study group and 152 in the control group.
The researchers collected the data for the study. They administered the pretest and filled out the personal information form prior to the planned individual education. The mothers were asked to remember the pseudonyms they used on the pretest and to use the same pseudonym on the posttest. Following the pretest, the mothers in the study group were taken into a separate room at the FHC and asked to breastfeed their infants. The mothers' breastfeeding behaviors were observed. After the breastfeeding, each mother was provided an average 30-minute session of individual education. All of the mothers in the study group received the education from the same researcher. Both audio and visual materials were used in the mothers' training. The researchers educated the mothers on breastfeeding techniques in an effort to encourage them to develop the skill of correctly using the positions taught and then the mothers were asked to practice what they had learned. The researcher took care to be positive and support whenever the mother attempted the right move in breastfeeding while also providing encouraging feedback when something went wrong. Included in the content of the education were the topics of the formation of breast milk and its benefits, the duration of breastfeeding, the sufficiency of breast milk, factors that reduced and increased it, things to look out for before breastfeeding, taking the right position for breastfeeding and positioning the baby on the breast, the steps in breastfeeding, burping the baby afterwards, milking and storing the mother's milk, and other issues that could pose problems during breastfeeding (Turkish Ministry of Health Basic Health Services General Directorate 2008). To test the retention of what was learned in the training, a posttest was administered to the groups one month following the education.
The Personal Information Form and the Breastfeeding Behaviors and Traditional Practices Assessment Form were used as data collection tools.
Statistical analyses were performed using IBM SPSS (Statistical Package for Social Sciences) Statistics 22 software. Descriptive statistics (means, standard deviation, frequencies and percentages) were used in the analysis of the findings. Normality tests (Kolmogorov-Smirnov Test) were performed on all continuous variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was designed to be parallel group, randomized controlled study (1:1). Power was calculated using the GPower 3.1 program. In the power analysis performed at a confidence interval of 95% and a margin of error of plus/minus 5%, sample size was calculated as a total of 304 mothers with 152 in the study group and 152 in the control group.A total of 304 mothers were evenly and homogeneously assigned to both groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Breastfeeding EducationThe mothers in the experimental group (152) were administered. |
| Control Group | No intervention | –The mothers in the control group (152) were administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- To receive breasfeeding education
- To have singleton birth or one infant
- Not have complications postpartum period
- Not have chronic diseases or mental disorders
- Older than 18 years
Key exclusion criteria (11 listed)
- Not receive breasfeeding education
- Having multiple birth or more than a baby
- Having complications postpartum period
- Having chronic diseases or mental disorders
- Younger than 18 years
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 |
|---|---|---|
| Breastfeeding EducationThe mothers were asked to remember the pseudonyms they used on the pretest and to use the same pseudonym on the posttest. Following the pretest, the mothers in the study group were taken into a separate room at the FHC and asked to breastfeed their infants. The mothers' breastfeeding behaviors were observed. After the breastfeeding, each mother was provided an average 30-minute session of individual education. All of the mothers in the study group received the education from the same researcher. Both audio and visual materials were used in the mothers' training. | Behavioural | Experimental Group |
Primary outcome
Pre-Education Mothers' traditional breastfeeding practices
Time frame: 20 minute after the admittance to the family health centers
The Breastfeeding Behaviors Form was created in line with the literature. The questionnaires were filled out by the researchers using the face-to-face interview method. The questionnaire for Breastfeeding Behaviors included the following questions: Education about mother's milk and breastfeeding, When did you first breastfeed your baby after birth? Have you given your baby the first milk from your breast? Has your baby been given any food other than breast milk after birth? Why are you giving other food to your baby? Have you continued to feed your baby any other food? Do you give your baby water after breastfeeding? Breastfeeding Length (Daily)-Frequency (Daily)-Position-Latching, Having Problems with Breastfeeding, b. How long do you intend to breastfeed your baby?
Pre-Education Breastfeeding behavior
Time frame: 20 minute after the admittance to the family health centers
Traditional Practices Assessment Form was created in line with the literature. The questionnaires were filled out by the researchers using the face-to-face interview method. The Mother's Traditional Breastfeeding Practices Assessment Form included the following questions: Are there any traditional practices you use for breastfeeding? Do you think the traditional Practices you use for breastfeeding are useful? Who suggested traditional practices regarding breastfeeding? Do you voluntarily use traditional breastfeeding practices? Are There Foods You Consume to Increase Breast Milk? Who recommended the foods you consume to increase breast milk? Do you think the Food You Consume to Increase Breast Milk is beneficial? Do you voluntarily consume the foods you consume to increase breast milk?
2 secondary outcomes
Post-Education
Time frame: 1 month following the breastfeeding education.
Post-Education
Time frame: 1 month following the breasfeeding education.
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 12 Jan 2021.
- Background: PubMed 28303701Zielinska MA, Sobczak A, Hamulka J. Breastfeeding knowledge and exclusive breastfeeding of infants in first six months of life. Rocz Panstw Zakl Hig. 2017;68(1):51-59.
- Background: PubMed 28673077Bellu R, Condo M. Breastfeeding promotion: evidence and problems. Pediatr Med Chir. 2017 Jun 28;39(2):156. doi: 10.4081/pmc.2017.156.
- Background: PubMed 31764775Huang P, Yao J, Liu X, Luo B. Individualized intervention to improve rates of exclusive breastfeeding: A randomised controlled trial. Medicine (Baltimore). 2019 Nov;98(47):e17822. doi: 10.1097/MD.0000000000017822.
- Background: PubMed 27917213Sharma A. Efficacy of early skin-to-skin contact on the rate of exclusive breastfeeding in term neonates: a randomized controlled trial. Afr Health Sci. 2016 Sep;16(3):790-797. doi: 10.4314/ahs.v16i3.20.
- Background: PubMed 26880166Sandoval Jurado L, Jimenez Baez MV, Olivares Juarez S, de la Cruz Olvera T. [Breastfeeding, complementary feeding and risk of childhood obesity]. Aten Primaria. 2016 Nov;48(9):572-578. doi: 10.1016/j.aprim.2015.10.004. Epub 2016 Feb 12. Spanish.
- Background: PubMed 28244064McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD001141. doi: 10.1002/14651858.CD001141.pub5.
- Background: PubMed 31140258Hay G, Baerug AB. The benefits of exclusive breastfeeding up to six months. Tidsskr Nor Laegeforen. 2019 May 3;139(9). doi: 10.4045/tidsskr.19.0105. Print 2019 May 28. No abstract available. English, Norwegian.
- Background: PubMed 29980160Del Ciampo LA, Del Ciampo IRL. Breastfeeding and the Benefits of Lactation for Women's Health. Rev Bras Ginecol Obstet. 2018 Jun;40(6):354-359. doi: 10.1055/s-0038-1657766. Epub 2018 Jul 6.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Education in people with Breastfeeding and Breasfeeding Traditional Practices, run by Aysegul Durmaz at 1 site in Turkey (Türkiye).
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 10 inclusion and 11 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 12 Jan 2021. 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 Turkey (Türkiye). 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?
Pre-Education Mothers' traditional breastfeeding practices (time frame: 20 minute after the admittance to the family health centers). The study lists 2 primary outcomes in all. 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 NCT04705675, which also lists 8 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 12 Jan 2021.