BreastfeedingNCT04021667
The Effect Of Indıvıdual and Group Breastfeedıng Traınıng Of Candidate Mother And Father
A study testing educational intervention in people with Breastfeeding and Education, run by Ege University.
Trial summary
Breast feeding is the primary step for healthy generations. Breast milk protects against diseases of childhood period starting from infancy till adulthood. Inspite of the benefits of breast milk due to various reasons a lot of women all around the world and in our country can not begin breast feeding and leave it at… 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?
- educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 30 Sep 2014
- 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
- Agree to participate in the study
- Having the first pregnancy
- Communicable
- Living with his wife
- Participation in education with his wife
- Completion of 36 weeks of gestational week
- Pregnant women without risk.
Who cannot join
- -
About this study
Official title: The Effect Of Indıvıdual And Group Breast Feedıng Traınıng Of Future Mother And Father At Postpartum Perıod On Breast Feedıng Self-Effıcacy And Attıtude:Randomızed Controlled Study
Breast feeding is the primary step for healthy generations. Breast milk protects against diseases of childhood period starting from infancy till adulthood. Inspite of the benefits of breast milk due to various reasons a lot of women all around the world and in our country can not begin breast feeding and leave it at an early stage even if they start once. According to Turkey Population and Health Investigation (TPHI) data of 2013; while the rate of only breast feeding among; 0-1 month babies is 57.9%, among babies under 6 months this rate falls to 10.0%. In the case of maternals not carrying out the whole breast feeding conditions situations such as milk secretion decrease, troubles related to breast, babies declining breast and ending breast feeding at an early stage are seen. These problems are related to the self-effıcacy that maternal feels towards breast feeding. The researches show that in addition to the maternal, father's attitude throughout pregnancy is also effective on starting breast feeding, sustaining and maintaining it efficiently.
With this research it has been aimed to evaluate the effect of individual and group breast feeding training of future mother and father at postpartum period on breast-feeding self-effıcacy and attitude.
Read more
Research data has been gathered at Turkey Public Hospitals Institution Izmir North Public Hospitals Association of T.R Ministry of Health Tepecik Education and Reserach Hospital between the dates 01 March-30 September 2014.
As a result; it has been seen that breast feeding training is not alone enough to improve self sufficiency and attitude, and maternals have to be supported by health staff at postpartum period in hospital. It is suggested to include also fathers to the breast feeding training provided at pregnancy period.
Read the detailed description
Breastfeeding training was given to the mother and father candidates in the individual and group education group. At this stage, standard care and service in the hospital was offered to the mothers and fathers in the control group. A follow-up plan was prepared for all the mothers and fathers after the discharge from the phone.
- Conditions
- Breastfeeding, Education
- Being tested
- educational intervention
- Keywords
- Breastfeeding, Parents Training, Self-Effıcacy, Attitude
- 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.
educational interventionOther
İndividual and Group Breastfeeding Education:It was taken into consideration that mothers and fathers who do not have breastfeeding experience in the antenatal period feel better in terms of their perception of the education given, and education is provided with adult education principles.Breastfeeding training slides, cloth nipple model, dummy dolls were used during the training and lecture, demonstration and application and breastfeeding training were provided.At the end of the training, they were given time to ask questions and their feedback was received.Control Group:Routine procedures in the clinic were performed for the mother and father candidates.The data of the mother and father who came to the hospital for antenatal follow-up and control were collected in four stages.
| Study group | Role | What they receive |
|---|---|---|
| INDIVIDUAL BREASTFEEDING TRAINING | Experimental | Individual Breastfeeding Training: Mother and father candidates who applied to the pregnant outpatient clinic and met the study criteria were included in the study.
After the informed consent was signed, the socio-demographic questionnaire including obstetric history and breastfeeding history, IOWA infant nutrition attitude scale and Breastfeeding Self-Efficacy Scale were applied to the mother and father candidates. Receives: Other: educational intervention |
| GROUP BREASTFEEDING TRAINING | Experimental | Group Breastfeeding Training: Mother and father candidates who applied to the pregnant outpatient clinic and met the study criteria were included in the study.
After the informed consent was signed, the socio-demographic questionnaire including obstetric history and breastfeeding history, IOWA infant nutrition attitude scale and Breastfeeding Self-Efficacy Scale were applied to the mother and father candidates.The groups were composed of five pairs of parents. Receives: Other: educational intervention |
| Control Group | No intervention | Control Group: Mother and father candidates who applied to the pregnant outpatient clinic and met the study criteria were included in the study.After the informed consent was signed, the socio-demographic questionnaire including obstetric history and breastfeeding history, IOWA infant nutrition attitude scale and Breastfeeding Self-Efficacy Scale were applied to the mother and father candidates. Routine procedures were applied to the mother and father candidates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up after discharge
Questionnaires were prepared separately for parents in each follow-up. Breastfeeding status, nipple cracking, breastfeeding support status were evaluated in the first week, sixth week and fourth month in the mother follow-up forms.
The questionnaire to be applied during pregnancy consists of three topics and a total of 25 questions.
There are questions about the sociodemographic characteristics (10), fertility characteristics (9) and breastfeeding characteristics (6) of the mothers.
In the questionnaire to be applied in the first week after birth, there are questions about the characteristics of birth and breastfeeding (30).
In the sixth week, there is a questionnaire (18) containing questions about breastfeeding and finally a questionnaire containing questions about breastfeeding status (18) at the fourth month.
During the first week, sixth week and fourth month follow-up, fathers' breastfeeding support status was questioned.
Measured: Four months
Breastfeeding Self-Efficacy Scale:
This scale was developed by Cindy-Lee Dennis to measure breastfeeding self-efficacy and consists of 2 sub-scales and 33 items. The cronbach alpha value of the scale developed by Cindy-Lee Dennis was measured as 0.95. The validity and reliability of the breastfeeding self-efficacy scale in Turkish was made by Eksioglu. The Cronbach's alpha coefficient was 0.91 and the Cronbach's alpha coefficient of the "Technical" sub-dimension was 0.89. Breastfeeding self-efficacy increases as the total score increases.The lowest score is 33 and the highest score is 165. The scale was administered to mothers four times. The first application was performed before the training in antenatal period and the other applications were done in the first week, sixth week and fourth month.
Measured: Four months
IOWA Infant Feeding and Attitude Scale (IIFAS)
Developed by De La Mora and Russell, the IIFAS was developed to assess the attitudes of mothers to breastfeeding and consists of 17 items. The cronbach's alpha value of the scale was 0.86. The validity and reliability study in our country was conducted by Eksioğlu et al. And the Cronbach's alpha coefficient was calculated as 0.71. It is designed to estimate the time of breastfeeding as well as choice of infant feeding method.
Scale; It consists of 17 items evaluated with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Nine of the items showed positive formula feeding, whereas these items were counter-rated.
The total score was between 17 and 85, and the higher the mean score of the scale, the higher the positive attitude of breastfeeding, and the lower the mean score of the scale, the higher the tendency towards formula feeding.
The scale was applied to the parents four times.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Mar 2014
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The pregnant women and partners who came to the hospital were evaluated in terms of sample criteria and randomized sampling was divided into three groups. In order to be able to perform randomized sampling, the selection of the groups to the individual breastfeeding education, group breastfeeding education and control group was determined by throwing a coin. After the first group was identified, a research group was taken for each day.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEŞİM YEŞİL, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021667
- Sponsor's protocol ID
- 0000-0003-2847-6978
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
PubMed 26869575Eidelman AI. Breastfeeding and the use of human milk: an analysis of the American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeed Med. 2012 Oct;7(5):323-4. doi: 10.1089/bfm.2012.0067. Epub 2012 Sep 4. No abstract available.
PubMed 22946888Abbass-Dick J, Stern SB, Nelson LE, Watson W, Dennis CL. Coparenting breastfeeding support and exclusive breastfeeding: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):102-10. doi: 10.1542/peds.2014-1416. Epub 2014 Dec 1.
PubMed 25452653Mangrio E, Persson K, Bramhagen AC. Sociodemographic, physical, mental and social factors in the cessation of breastfeeding before 6 months: a systematic review. Scand J Caring Sci. 2018 Jun;32(2):451-465. doi: 10.1111/scs.12489. Epub 2017 Jun 1.
PubMed 28569436Maycock B, Binns CW, Dhaliwal S, Tohotoa J, Hauck Y, Burns S, Howat P. Education and support for fathers improves breastfeeding rates: a randomized controlled trial. J Hum Lact. 2013 Nov;29(4):484-90. doi: 10.1177/0890334413484387. Epub 2013 Apr 19.
PubMed 23603573
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Indıvıdual And Group Breast Feedıng Traınıng Of Future Mother And Father At Postpartum Perıod On Breast Feedıng Self-Effıcacy And Attıtude:Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT04021667
- Acronym / sponsor ID
- 0000-0003-2847-6978
- Conditions
- Breastfeeding, Education
- Keywords
- Breastfeeding, Parents Training, Self-Effıcacy, Attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 16 Jul 2019 (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.
Breast feeding is the primary step for healthy generations. Breast milk protects against diseases of childhood period starting from infancy till adulthood. Inspite of the benefits of breast milk due to various reasons a lot of women all around the world and in our country can not begin breast feeding and leave it at an early stage even if they start once. According to Turkey Population and Health Investigation (TPHI) data of 2013; while the rate of only breast feeding among; 0-1 month babies is 57.9%, among babies under 6 months this rate falls to 10.0%. In the case of maternals not carrying out the whole breast feeding conditions situations such as milk secretion decrease, troubles related to breast, babies declining breast and ending breast feeding at an early stage are seen. These problems are related to the self-effıcacy that maternal feels towards breast feeding. The researches show that in addition to the maternal, father's attitude throughout pregnancy is also effective on starting breast feeding, sustaining and maintaining it efficiently.
With this research it has been aimed to evaluate the effect of individual and group breast feeding training of future mother and father at postpartum period on breast-feeding self-effıcacy and attitude.
Research data has been gathered at Turkey Public Hospitals Institution Izmir North Public Hospitals Association of T.R Ministry of Health Tepecik Education and Reserach Hospital between the dates 01 March-30 September 2014.
As a result; it has been seen that breast feeding training is not alone enough to improve self sufficiency and attitude, and maternals have to be supported by health staff at postpartum period in hospital. It is suggested to include also fathers to the breast feeding training provided at pregnancy period.
Detailed description
Breastfeeding training was given to the mother and father candidates in the individual and group education group. At this stage, standard care and service in the hospital was offered to the mothers and fathers in the control group. A follow-up plan was prepared for all the mothers and fathers after the discharge from the phone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The pregnant women and partners who came to the hospital were evaluated in terms of sample criteria and randomized sampling was divided into three groups. In order to be able to perform randomized sampling, the selection of the groups to the individual breastfeeding education, group breastfeeding education and control group was determined by throwing a coin. After the first group was identified, a research group was taken for each day.
| Arm | Type | Receives |
|---|---|---|
| INDIVIDUAL BREASTFEEDING TRAINING | Experimental | Other: educational interventionIndividual Breastfeeding Training: Mother and father candidates who applied to the pregnant outpatient clinic and met the study criteria were included in the study. After the informed consent was signed, the socio-demographic questionnaire including obstetric history and breastfeeding history, IOWA infant nutrition attitude scale and Breastfeeding Self-Efficacy Scale were applied to the mother and father candidates. |
| GROUP BREASTFEEDING TRAINING | Experimental | Other: educational interventionGroup Breastfeeding Training: Mother and father candidates who applied to the pregnant outpatient clinic and met the study criteria were included in the study. After the informed consent was signed, the socio-demographic questionnaire including obstetric history and breastfeeding history, IOWA infant nutrition attitude scale and Breastfeeding Self-Efficacy Scale were applied to the mother and father candidates.The groups were composed of five pairs of parents. |
| Control Group | No intervention | –Control Group: Mother and father candidates who applied to the pregnant outpatient clinic and met the study criteria were included in the study.After the informed consent was signed, the socio-demographic questionnaire including obstetric history and breastfeeding history, IOWA infant nutrition attitude scale and Breastfeeding Self-Efficacy Scale were applied to the mother and father candidates. Routine procedures were applied to the mother and father candidates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Agree to participate in the study
- Having the first pregnancy
- Communicable
- Living with his wife
- Participation in education with his wife
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| educational interventionİndividual and Group Breastfeeding Education:It was taken into consideration that mothers and fathers who do not have breastfeeding experience in the antenatal period feel better in terms of their perception of the education given, and education is provided with adult education principles.Breastfeeding training slides, cloth nipple model, dummy dolls were used during the training and lecture, demonstration and application and breastfeeding training were provided.At the end of the training, they were given time to ask questions and their feedback was received.Control Group:Routine procedures in the clinic were performed for the mother and father candidates.The data of the mother and father who came to the hospital for antenatal follow-up and control were collected in four stages. | Other | GROUP BREASTFEEDING TRAINING, INDIVIDUAL BREASTFEEDING TRAINING |
Primary outcome
Follow-up after discharge
Time frame: Four months
Questionnaires were prepared separately for parents in each follow-up. Breastfeeding status, nipple cracking, breastfeeding support status were evaluated in the first week, sixth week and fourth month in the mother follow-up forms. The questionnaire to be applied during pregnancy consists of three topics and a total of 25 questions. There are questions about the sociodemographic characteristics (10), fertility characteristics (9) and breastfeeding characteristics (6) of the mothers. In the questionnaire to be applied in the first week after birth, there are questions about the characteristics of birth and breastfeeding (30). In the sixth week, there is a questionnaire (18) containing questions about breastfeeding and finally a questionnaire containing questions about breastfeeding status (18) at the fourth month. During the first week, sixth week and fourth month follow-up, fathers' breastfeeding support status was questioned.
Breastfeeding Self-Efficacy Scale:
Time frame: Four months
This scale was developed by Cindy-Lee Dennis to measure breastfeeding self-efficacy and consists of 2 sub-scales and 33 items. The cronbach alpha value of the scale developed by Cindy-Lee Dennis was measured as 0.95. The validity and reliability of the breastfeeding self-efficacy scale in Turkish was made by Eksioglu. The Cronbach's alpha coefficient was 0.91 and the Cronbach's alpha coefficient of the "Technical" sub-dimension was 0.89. Breastfeeding self-efficacy increases as the total score increases.The lowest score is 33 and the highest score is 165. The scale was administered to mothers four times. The first application was performed before the training in antenatal period and the other applications were done in the first week, sixth week and fourth month.
IOWA Infant Feeding and Attitude Scale (IIFAS)
Time frame: Four months
Developed by De La Mora and Russell, the IIFAS was developed to assess the attitudes of mothers to breastfeeding and consists of 17 items. The cronbach's alpha value of the scale was 0.86. The validity and reliability study in our country was conducted by Eksioğlu et al. And the Cronbach's alpha coefficient was calculated as 0.71. It is designed to estimate the time of breastfeeding as well as choice of infant feeding method. Scale; It consists of 17 items evaluated with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Nine of the items showed positive formula feeding, whereas these items were counter-rated. The total score was between 17 and 85, and the higher the mean score of the scale, the higher the positive attitude of breastfeeding, and the lower the mean score of the scale, the higher the tendency towards formula feeding. The scale was applied to the parents four times.
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 23 Jul 2019.
- Background: PubMed 26869575Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
- Background: PubMed 22946888Eidelman AI. Breastfeeding and the use of human milk: an analysis of the American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeed Med. 2012 Oct;7(5):323-4. doi: 10.1089/bfm.2012.0067. Epub 2012 Sep 4. No abstract available.
- Background: PubMed 25452653Abbass-Dick J, Stern SB, Nelson LE, Watson W, Dennis CL. Coparenting breastfeeding support and exclusive breastfeeding: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):102-10. doi: 10.1542/peds.2014-1416. Epub 2014 Dec 1.
- Background: PubMed 28569436Mangrio E, Persson K, Bramhagen AC. Sociodemographic, physical, mental and social factors in the cessation of breastfeeding before 6 months: a systematic review. Scand J Caring Sci. 2018 Jun;32(2):451-465. doi: 10.1111/scs.12489. Epub 2017 Jun 1.
- Background: PubMed 23603573Maycock B, Binns CW, Dhaliwal S, Tohotoa J, Hauck Y, Burns S, Howat P. Education and support for fathers improves breastfeeding rates: a randomized controlled trial. J Hum Lact. 2013 Nov;29(4):484-90. doi: 10.1177/0890334413484387. Epub 2013 Apr 19.
- Individual participant dataSharing planned: No
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention in people with Breastfeeding and Education, run by Ege University.
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 1 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Follow-up after discharge (time frame: Four months). The study lists 3 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 NCT04021667, which also lists 5 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 23 Jul 2019.