Breastfeeding EducationNCT06317974
The Effect of Breastfeeding Education on Breast Milk Perception and Self-Efficacy in the Pregnancy Health Belief Model
A study testing Breastfeeding education based on the Health Belief model in people with Breastfeeding Education, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Education
- What is being tested?
- Breastfeeding education based on the Health Belief model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2022to 15 Feb 2023
- 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
- Those aged 18 and over
- Living in the same house with his/her spouse
- Able to speak and understand Turkish
- In the 27th week of pregnancy and above
- Having a first pregnancy
- Using a phone
- Couples willing to participate in the research
Who cannot join
- multiparous
- Receiving psychiatric or neurological treatment that affects cooperation and cognitive functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breastfeeding Education Based on the Health Belief Model Given ın the Third Trimester of Pregnancy on Couples Breast Milk Perception and Self-efficacy
Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk.
Read the detailed description
Introduction: It is known that breast milk is crucial for newborns and infants. The Health Belief Model has been widely used in recent years to improve and promote health behaviors.
Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk.
Method: This randomized controlled study was conducted between June 30, 2022, and December 31, 2022, at the Dr. Selahattin Cizrelioğlu State Hospital in Şırnak. A total of 220 participants, including 110 couples who met the inclusion criteria, were randomly assigned to an intervention group (55 couples) and a control group (55 couples). Data were collected using a "Participant Information Form" for socio-demographic and obstetric information, the "Adults' Perception of Breast Milk Scale" for assessing perception related to breast milk, the "Pregnancy Breastfeeding Self-Efficacy Scale- Short Form" for evaluating mothers' breastfeeding self-efficacy during the antenatal period, and the "Paternal Breastfeeding Self-Efficacy Scale" for assessing fathers' breastfeeding self-efficacy during the pregnancy period.
- Conditions
- Breastfeeding Education
- Being tested
- Breastfeeding education based on the Health Belief model
- Keywords
- Health Belief Model, Breastfeeding Self-Efficacy, Breast milk, Breastfeeding, Parent education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding education based on the Health Belief modelBehavioural
Training was given face to face with the participant, lasting approximately 40 minutes. One week after the training presentation, three short messages about the training were sent to the couples (both the pregnant woman and her partner) every other day. Two weeks after the training was given, a phone call was made for feedback. Post-test data were taken four weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Breastfeeding education was given to the intervention group based on the health belief model. Receives: Behavioral: Breastfeeding education based on the Health Belief model |
| control group | No intervention | The control group received standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' and fathers' perception of breast milk, assessed using the Adults' Breast Milk Perception Scale.
In this study, it was determined that breastfeeding education given based on the health belief model in the last trimester of pregnancy increased the breast milk perception levels of expectant mothers and fathers.
Measured: 30 days
Secondary outcomes (1)
Breastfeeding self-efficacy of mothers evaluated using the Breastfeeding Self-Efficacy Scale-Short Form during Pregnancy
In this study, it was determined that breastfeeding education given in the pregnancy health belief model increased pregnant women's breastfeeding self-efficacy levels during pregnancy.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start30 Jun 2022
- Primary completion31 Dec 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding EducationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Randomized controlled, experimental research design in pre-test, post-test design Made with
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leman Yılmaz Cesur, Istanbul University - Cerrahpasa
- Investigators
- Leman Yılmaz Cesur, Principal investigator, Msc Midwife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317974
- Sponsor's protocol ID
- 2022/210
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dror DK, Allen LH. Overview of Nutrients in Human Milk. Adv Nutr. 2018 May 1;9(suppl_1):278S-294S. doi: 10.1093/advances/nmy022.
PubMed 29846526Alex A, Bhandary E, McGuire KP. Anatomy and Physiology of the Breast during Pregnancy and Lactation. Adv Exp Med Biol. 2020;1252:3-7. doi: 10.1007/978-3-030-41596-9_1.
PubMed 32816256Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
PubMed 23178060Boix-Amoros A, Collado MC, Van't Land B, Calvert A, Le Doare K, Garssen J, Hanna H, Khaleva E, Peroni DG, Geddes DT, Kozyrskyj AL, Warner JO, Munblit D. Reviewing the evidence on breast milk composition and immunological outcomes. Nutr Rev. 2019 Aug 1;77(8):541-556. doi: 10.1093/nutrit/nuz019.
PubMed 31111150Ceriani Cernadas JM. Colostrum and breast milk in the neonatal period: The benefits keep adding up. Arch Argent Pediatr. 2018 Aug 1;116(4):234-235. doi: 10.5546/aap.2018.eng.234. No abstract available. English, Spanish.
PubMed 30016015Chen S, Li L, Sun Q, Chen S, Cheng J, Xiong S. Effect of IMB Model Combined with Spousal Support Breastfeeding Intervention on PBSES Score and Breastfeeding Rate of Primipara with Chronic Hepatitis B Virus Infection. Biomed Res Int. 2022 Sep 15;2022:9661408. doi: 10.1155/2022/9661408. eCollection 2022.
PubMed 36158886Dagla C, Antoniou E, Sarantaki A, Iliadou M, Mrvoljak-Theodoropoulou I, Andersson E, Dagla M. The Effect of Antenatal Education on Expectant Fathers' Attitudes toward Breastfeeding and Attachment to the Fetus. Nurs Rep. 2023 Feb 12;13(1):243-254. doi: 10.3390/nursrep13010023.
PubMed 36810274Dennis CL, Faux S. Development and psychometric testing of the Breastfeeding Self-Efficacy Scale. Res Nurs Health. 1999 Oct;22(5):399-409. doi: 10.1002/(sici)1098-240x(199910)22:53.0.co;2-4.
PubMed 10520192Dennis CL, Brennenstuhl S, Abbass-Dick J. Measuring paternal breastfeeding self-efficacy: A psychometric evaluation of the Breastfeeding Self-Efficacy Scale-Short Form among fathers. Midwifery. 2018 Sep;64:17-22. doi: 10.1016/j.midw.2018.05.005. Epub 2018 May 15.
PubMed 29864577Correction to: ABM Clinical Protocol #8: Human Milk Storage Information for Home Use for Full-Term Infants, Revised 2017, by Eglash A, Simon L, and The Academy of Breastfeeding Medicine Breastfeed Med 2017;12(7):390-395. DOI: 10.1089/dna.2017.29047.aje. Breastfeed Med. 2018 Jul/Aug;13(6):459. doi: 10.1089/bfm.2017.29047.aje.correx. Epub 2018 Jun 29. No abstract available.
PubMed 29958002Hu L, Ding T, Hu J, Luo B. Promoting breastfeeding in Chinese women undergoing cesarean section based on the health belief model: A randomized controlled trial. Medicine (Baltimore). 2020 Jul 10;99(28):e20815. doi: 10.1097/MD.0000000000020815.
PubMed 32664074Kehinde J, O'Donnell C, Grealish A. The effectiveness of prenatal breastfeeding education on breastfeeding uptake postpartum: A systematic review. Midwifery. 2023 Mar;118:103579. doi: 10.1016/j.midw.2022.103579. Epub 2022 Dec 14.
PubMed 36580847Lumbiganon P, Martis R, Laopaiboon M, Festin MR, Ho JJ, Hakimi M. Antenatal breastfeeding education for increasing breastfeeding duration. Cochrane Database Syst Rev. 2016 Dec 6;12(12):CD006425. doi: 10.1002/14651858.CD006425.pub4.
PubMed 27922724Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.
PubMed 18541350Abuidhail J, Mrayan L, Jaradat D. Evaluating effects of prenatal web-based breastfeeding education for pregnant mothers in their third trimester of pregnancy: Prospective randomized control trial. Midwifery. 2019 Feb;69:143-149. doi: 10.1016/j.midw.2018.11.015. Epub 2018 Nov 28.
PubMed 30513445
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Education Based on the Health Belief Model Given ın the Third Trimester of Pregnancy on Couples Breast Milk Perception and Self-efficacy
- ClinicalTrials.gov ID
- NCT06317974
- Acronym / sponsor ID
- 2022/210
- Conditions
- Breastfeeding Education
- Keywords
- Health Belief Model, Breastfeeding Self-Efficacy, Breast milk, Breastfeeding, Parent education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 19 Mar 2024 (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.
Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk.
Detailed description
Introduction: It is known that breast milk is crucial for newborns and infants. The Health Belief Model has been widely used in recent years to improve and promote health behaviors.
Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk.
Method: This randomized controlled study was conducted between June 30, 2022, and December 31, 2022, at the Dr. Selahattin Cizrelioğlu State Hospital in Şırnak. A total of 220 participants, including 110 couples who met the inclusion criteria, were randomly assigned to an intervention group (55 couples) and a control group (55 couples). Data were collected using a "Participant Information Form" for socio-demographic and obstetric information, the "Adults' Perception of Breast Milk Scale" for assessing perception related to breast milk, the "Pregnancy Breastfeeding Self-Efficacy Scale- Short Form" for evaluating mothers' breastfeeding self-efficacy during the antenatal period, and the "Paternal Breastfeeding Self-Efficacy Scale" for assessing fathers' breastfeeding self-efficacy during the pregnancy period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled, experimental research design in pre-test, post-test design Made with
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Breastfeeding education based on the Health Belief modelBreastfeeding education was given to the intervention group based on the health belief model. |
| control group | No intervention | –The control group received standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Those aged 18 and over
- Living in the same house with his/her spouse
- Able to speak and understand Turkish
- In the 27th week of pregnancy and above
- Having a first pregnancy
Key exclusion criteria (2 listed)
- multiparous
- Receiving psychiatric or neurological treatment that affects cooperation and cognitive functions
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 education based on the Health Belief modelTraining was given face to face with the participant, lasting approximately 40 minutes. One week after the training presentation, three short messages about the training were sent to the couples (both the pregnant woman and her partner) every other day. Two weeks after the training was given, a phone call was made for feedback. Post-test data were taken four weeks later. | Behavioural | Intervention group |
Primary outcome
Mothers' and fathers' perception of breast milk, assessed using the Adults' Breast Milk Perception Scale.
Time frame: 30 days
In this study, it was determined that breastfeeding education given based on the health belief model in the last trimester of pregnancy increased the breast milk perception levels of expectant mothers and fathers.
1 secondary outcome
Breastfeeding self-efficacy of mothers evaluated using the Breastfeeding Self-Efficacy Scale-Short Form during Pregnancy
Time frame: 30 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 19 Mar 2024.
- Background: PubMed 29846526Dror DK, Allen LH. Overview of Nutrients in Human Milk. Adv Nutr. 2018 May 1;9(suppl_1):278S-294S. doi: 10.1093/advances/nmy022.
- Background: PubMed 32816256Alex A, Bhandary E, McGuire KP. Anatomy and Physiology of the Breast during Pregnancy and Lactation. Adv Exp Med Biol. 2020;1252:3-7. doi: 10.1007/978-3-030-41596-9_1.
- Background: PubMed 23178060Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
- Background: PubMed 31111150Boix-Amoros A, Collado MC, Van't Land B, Calvert A, Le Doare K, Garssen J, Hanna H, Khaleva E, Peroni DG, Geddes DT, Kozyrskyj AL, Warner JO, Munblit D. Reviewing the evidence on breast milk composition and immunological outcomes. Nutr Rev. 2019 Aug 1;77(8):541-556. doi: 10.1093/nutrit/nuz019.
- Background: PubMed 30016015Ceriani Cernadas JM. Colostrum and breast milk in the neonatal period: The benefits keep adding up. Arch Argent Pediatr. 2018 Aug 1;116(4):234-235. doi: 10.5546/aap.2018.eng.234. No abstract available. English, Spanish.
- Background: PubMed 36158886Chen S, Li L, Sun Q, Chen S, Cheng J, Xiong S. Effect of IMB Model Combined with Spousal Support Breastfeeding Intervention on PBSES Score and Breastfeeding Rate of Primipara with Chronic Hepatitis B Virus Infection. Biomed Res Int. 2022 Sep 15;2022:9661408. doi: 10.1155/2022/9661408. eCollection 2022.
- Background: PubMed 36810274Dagla C, Antoniou E, Sarantaki A, Iliadou M, Mrvoljak-Theodoropoulou I, Andersson E, Dagla M. The Effect of Antenatal Education on Expectant Fathers' Attitudes toward Breastfeeding and Attachment to the Fetus. Nurs Rep. 2023 Feb 12;13(1):243-254. doi: 10.3390/nursrep13010023.
- Background: PubMed 10520192Dennis CL, Faux S. Development and psychometric testing of the Breastfeeding Self-Efficacy Scale. Res Nurs Health. 1999 Oct;22(5):399-409. doi: 10.1002/(sici)1098-240x(199910)22:53.0.co;2-4.
- Background: PubMed 29864577Dennis CL, Brennenstuhl S, Abbass-Dick J. Measuring paternal breastfeeding self-efficacy: A psychometric evaluation of the Breastfeeding Self-Efficacy Scale-Short Form among fathers. Midwifery. 2018 Sep;64:17-22. doi: 10.1016/j.midw.2018.05.005. Epub 2018 May 15.
- Background: PubMed 29958002Correction to: ABM Clinical Protocol #8: Human Milk Storage Information for Home Use for Full-Term Infants, Revised 2017, by Eglash A, Simon L, and The Academy of Breastfeeding Medicine Breastfeed Med 2017;12(7):390-395. DOI: 10.1089/dna.2017.29047.aje. Breastfeed Med. 2018 Jul/Aug;13(6):459. doi: 10.1089/bfm.2017.29047.aje.correx. Epub 2018 Jun 29. No abstract available.
- Background: PubMed 32664074Hu L, Ding T, Hu J, Luo B. Promoting breastfeeding in Chinese women undergoing cesarean section based on the health belief model: A randomized controlled trial. Medicine (Baltimore). 2020 Jul 10;99(28):e20815. doi: 10.1097/MD.0000000000020815.
- Background: PubMed 36580847Kehinde J, O'Donnell C, Grealish A. The effectiveness of prenatal breastfeeding education on breastfeeding uptake postpartum: A systematic review. Midwifery. 2023 Mar;118:103579. doi: 10.1016/j.midw.2022.103579. Epub 2022 Dec 14.
- Individual participant dataSharing planned: No
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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.
Leman Yılmaz Cesur principal investigator
Msc Midwife
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 based on the Health Belief model in people with Breastfeeding Education, run by Istanbul University - Cerrahpasa 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 7 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 19 Mar 2024. 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?
Mothers' and fathers' perception of breast milk, assessed using the Adults' Breast Milk Perception Scale. (time frame: 30 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 NCT06317974, which also lists 27 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 19 Mar 2024.