Breast FeedingNCT06585111
Effect of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration
A study testing Intervention in people with Breast Feeding, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective, randomized controlled experimental clinical trial was to examine the effect of individual counseling interventions based on the Health Action Process Approach Model on breastfeeding duration in twin pregnancies. 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
- Breast Feeding
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 15 Sep 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Who agreed to participate in the study,
- 18 years of age or older,
- Can speak and understand Turkish,
- Can read and write,
- Mothers whose breasts are suitable for breastfeeding
- Weeks between (28+0)-(37+6) of pregnancy
Who cannot join
- The baby has an anomaly in the mouth area
- The woman has language and communication problems
- The breasts are not suitable for breastfeeding (history of mastectomy surgery on both breasts)
- The mother or the baby is taking medication that prevents breastfeeding
- The woman has a previously diagnosed psychiatric disorder
- The mother does not plan to breastfeed her babies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration In Twin Pregnancies
The aim of this prospective, randomized controlled experimental clinical trial was to examine the effect of individual counseling interventions based on the Health Action Process Approach Model on breastfeeding duration in twin pregnancies. Women in the intervention group received breastfeeding education using motivational interviewing techniques, while women in the control group received routine clinical education and no intervention. Hypotheses of the study:
H1: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding self-efficacy than the control group.
Read more
H2: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding intentions than the control group.
H3: Postnatal breastfeeding self-efficacy of women who received individual intervention based on SESY model is higher than the control group.
H4: Breastfeeding motivation of women who received individual intervention based on the SESY model is higher than the control group.
H5: Women who received individual intervention based on the SESY model had higher rates of exclusive breastfeeding than the control group.
The women in the intervention group were given breastfeeding education with motivational interviewing techniques at 28-38 weeks of pregnancy in the prenatal period and 1-3 days, 1-2 weeks, 4-6 weeks, 4th month and 6th month in the postpartum period. The women in the control group did not receive any training by the researcher.
Read the detailed description
Evaluate the effect of individual counseling interventions based on the Health Action Process Approach Model (HAPA) on breastfeeding duration in twin pregnancies.
A total of 34 women in the intervention group and 34 women in the control group were followed up six times at 28-38 weeks in the antenatal period and 1-3 days, 1-2 weeks, 4-6 weeks, 4th month and 6th month in the postpartum period. Personal Information Form, HAPA Model Antenatal Period Motivational Interview Questionnaire, HAPA Model Postpartum Period Motivational Interview Questionnaire, Prenatal Breastfeeding Self-Efficacy Scale, Breastfeeding Intention Scale in Pregnant Women Expecting Twins, Breastfeeding Follow-up Form, Breastfeeding Motivation Scale Turkish version, Postnatal Breastfeeding Self-Efficacy Scale were applied to the intervention group. In the control group, Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, Breastfeeding Intention Scale in Pregnant Women Expecting Twins, Breastfeeding Follow-up Form, Breastfeeding Motivation Scale Turkish version, Postnatal Breastfeeding Self-Efficacy Scale were applied and they were followed up with routine clinical trainings.
- Conditions
- Breast Feeding
- Being tested
- Intervention
- Keywords
- Breas Feeding, Twins, Motivational Interviewing, Self Efficacy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
In the first motivational interview, the "HAPA Model Prenatal Motivation Interview Questionnaire", the first part of the "Personal Information Form", the "Prenatal Breastfeeding Self-Efficacy Scale", and the "Breastfeeding Intention Scale for Pregnant Women Expecting Twins" were applied. A brochure on breastfeeding twin babies prepared by the researcher was distributed to women. In the second interview, the "HAPA Model Postpartum Motivation Interview Scale", the second part of which was the "Personal Information Form", "Breastfeeding Follow-up Form", "Breastfeeding Motivation Scale" and "Postpartum Breastfeeding Self-Efficacy Scale" were applied. In the third meeting, the "Breastfeeding Follow-up Form" was applied. "Breastfeeding Motivation Scale", "Postpartum Breastfeeding Self-Efficacy Scale" and "Breastfeeding Follow-up Form" were applied in the fourth and fifth interviews, and "Breastfeeding Follow-up Form" was applied in the sixth interview.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Education | Experimental | Women in the intervention group received breastfeeding education through six motivational interviews based on the Health Action Process Approach (HAPA) Model (antenatal period 28-38 weeks, postpartum period 1-3 days, postpartum period 1-2 weeks, postpartum period 4-6 weeks, postpartum period 4th month, postpartum period 6th month). Receives: Other: Intervention |
| Control | No intervention | The women in the control group received six follow-ups based on the Health Action Process Approach (HAPA) Model (antenatal period 28-38 weeks, postpartum period 1-3 days, postpartum period 1-2 weeks, postpartum period 4-6 weeks, postpartum period 4th month, postpartum period 6th month). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding duration of twin babies until the sixth month postpartum after counseling
The duration of breastfeeding the twins was measured using a breastfeeding follow-up form after the counseling intervention using motivational interviewing techniques. The breastfeeding follow-up form included questions about the number of breastfeedings in the last 24 hours and the mothers' formula feeding status. Mothers who breastfed 9-12 times were considered to have breastfed their babies sufficiently. Mothers who breastfed their babies 6 times or less did not breastfeed their babies enough. Babies of mothers who give formula to their babies are interpreted as not receiving enough breast milk.
Measured: Postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months
Secondary outcomes (5)
Duration of exclusive breastfeeding of twin babies after consultation until the sixth month after birth
The duration of breastfeeding the twins was measured using a breastfeeding follow-up form after the counseling intervention using motivational interviewing techniques. The breastfeeding follow-up form included questions about the number of breastfeedings in the last 24 hours and the mothers' formula feeding status. Mothers who breastfed 9-12 times were considered to have breastfed their babies sufficiently. Mothers who breastfed their babies 6 times or less did not breastfeed their babies enough. Babies of mothers who give formula to their babies are interpreted as not receiving enough breast milk.
Measured: postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months
Breastfeeding Intention Level
The breastfeeding intention level of mothers of twin babies was measured with the breastfeeding intention scale in the prenatal period.The scale is a 5-point Likert scale. Items are scored from strongly disagree 1 to strongly agree 5. A minimum of 7 and a maximum of 35 points can be obtained from the scale. The higher the total score obtained from the scale, the higher the breastfeeding intention of pregnant women expecting twins. The scale can be used in both primiparous and multiparous pregnant women from the 20th gestational week until delivery. The scale can be easily completed by literate individuals.
Measured: In the prenatal period between 28-38 weeks of gestation
Prenatal Breastfeeding Self Efficacy Level
The prenatal breastfeeding self-efficacy level of the mothers of twin babies was measured with the prenatal breastfeeding self-efficacy scale after breastfeeding training with motivational interviewing techniques. The scale consists of a total of 19 items and four subgroups. Each item of the scale is classified as "1=Not at all sure", "2=Slightly sure", 3=Quite sure", 4=Very sure", 5= Completely sure". It is graded on a 5-point Likert scale. The lowest score that can be obtained from the total scale is 19 and the highest score is 95. It is evaluated over the total score. The higher the score, the higher the perception of breastfeeding self-efficacy.
Measured: In the Prenatal period between 28-38 weeks of gestation
Postnatal Breastfeeding Self Efficacy Scale Level
The postpartum breastfeeding self-efficacy levels of the mothers of twin babies were measured with the postnatal breastfeeding self-efficacy scale after breastfeeding training with motivational interviewing techniques. The Breastfeeding Self-Efficacy Scale developed by Dennis in 1999 consists of 33 items. Dennis developed the short form of the Breastfeeding Self-Efficacy Scale in 2003 by reducing it to 14 items. The Short Form Breastfeeding Self-Efficacy Scale is a 5-point Likert-type scale with 1= "I am never sure" and 5 = "I am always sure". The higher the score, the higher the breastfeeding self-efficacy.
Measured: Postpartum 1-3 days, postpartum 4-6 weeks, and postpartum 4th month.
Breastfeeding Motivation Level in Mothers of Twin Babies
The level of breastfeeding motivation in mothers of twin babies was measured by motivational interviewing techniques and breastfeeding motivation scale after breastfeeding education. The scale consists of 24 items. The scale was adapted into Turkish by Mızrak and Özerdoğan in 2017. The scale consists of 6 sub-dimensions. These are; integrated regulation first sub-dimension 13,14,16,19,15,21,18,24,22,23, intrinsic motivation and identified regulation second sub-dimension 11,8,16,3,14.6,8,11,13, internalized regulation-social approval third sub-dimension 4,5, internalized regulation-social pressure fourth sub-dimension 7,9, external regulation-infant health fifth sub-dimension 2,12. and external regulation-additional benefits sixth sub-dimension 20,1,17,10. Scale items are graded from 1=strongly disagree to 4=strongly agree.
Measured: 1-3 days postpartum, 4-6 weeks postpartum, and 4th month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start15 Sep 2022
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were divided into two groups: intervention and control groups. Interventions and follow-ups were carried out in six determined time periods.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÇİĞDEM KÖPRÜLÜ, Ege University
- Investigators
- Oya Kavlak, Prof. Dr., Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585111
- Sponsor's protocol ID
- EGEU-SBF-CK-01
- Status last verified
- Sep 2024
- First submitted
- 10 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be shared with other researchers after the study is published (after 6 months).
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration In Twin Pregnancies
- ClinicalTrials.gov ID
- NCT06585111
- Acronym / sponsor ID
- EGEU-SBF-CK-01
- Conditions
- Breast Feeding
- Keywords
- Breas Feeding, Twins, Motivational Interviewing, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 5 Sep 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.
The aim of this prospective, randomized controlled experimental clinical trial was to examine the effect of individual counseling interventions based on the Health Action Process Approach Model on breastfeeding duration in twin pregnancies. Women in the intervention group received breastfeeding education using motivational interviewing techniques, while women in the control group received routine clinical education and no intervention. Hypotheses of the study:
H1: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding self-efficacy than the control group.
H2: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding intentions than the control group.
H3: Postnatal breastfeeding self-efficacy of women who received individual intervention based on SESY model is higher than the control group.
H4: Breastfeeding motivation of women who received individual intervention based on the SESY model is higher than the control group.
H5: Women who received individual intervention based on the SESY model had higher rates of exclusive breastfeeding than the control group.
The women in the intervention group were given breastfeeding education with motivational interviewing techniques at 28-38 weeks of pregnancy in the prenatal period and 1-3 days, 1-2 weeks, 4-6 weeks, 4th month and 6th month in the postpartum period. The women in the control group did not receive any training by the researcher.
Detailed description
Evaluate the effect of individual counseling interventions based on the Health Action Process Approach Model (HAPA) on breastfeeding duration in twin pregnancies.
A total of 34 women in the intervention group and 34 women in the control group were followed up six times at 28-38 weeks in the antenatal period and 1-3 days, 1-2 weeks, 4-6 weeks, 4th month and 6th month in the postpartum period. Personal Information Form, HAPA Model Antenatal Period Motivational Interview Questionnaire, HAPA Model Postpartum Period Motivational Interview Questionnaire, Prenatal Breastfeeding Self-Efficacy Scale, Breastfeeding Intention Scale in Pregnant Women Expecting Twins, Breastfeeding Follow-up Form, Breastfeeding Motivation Scale Turkish version, Postnatal Breastfeeding Self-Efficacy Scale were applied to the intervention group. In the control group, Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, Breastfeeding Intention Scale in Pregnant Women Expecting Twins, Breastfeeding Follow-up Form, Breastfeeding Motivation Scale Turkish version, Postnatal Breastfeeding Self-Efficacy Scale were applied and they were followed up with routine clinical trainings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were divided into two groups: intervention and control groups. Interventions and follow-ups were carried out in six determined time periods.
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Education | Experimental | Other: InterventionWomen in the intervention group received breastfeeding education through six motivational interviews based on the Health Action Process Approach (HAPA) Model (antenatal period 28-38 weeks, postpartum period 1-3 days, postpartum period 1-2 weeks, postpartum period 4-6 weeks, postpartum period 4th month, postpartum period 6th month). |
| Control | No intervention | –The women in the control group received six follow-ups based on the Health Action Process Approach (HAPA) Model (antenatal period 28-38 weeks, postpartum period 1-3 days, postpartum period 1-2 weeks, postpartum period 4-6 weeks, postpartum period 4th month, postpartum period 6th month). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Who agreed to participate in the study,
- 18 years of age or older,
- Can speak and understand Turkish,
- Can read and write,
- Mothers whose breasts are suitable for breastfeeding
Key exclusion criteria (6 listed)
- The baby has an anomaly in the mouth area
- The woman has language and communication problems
- The breasts are not suitable for breastfeeding (history of mastectomy surgery on both breasts)
- The mother or the baby is taking medication that prevents breastfeeding
- The woman has a previously diagnosed psychiatric disorder
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 |
|---|---|---|
| InterventionIn the first motivational interview, the "HAPA Model Prenatal Motivation Interview Questionnaire", the first part of the "Personal Information Form", the "Prenatal Breastfeeding Self-Efficacy Scale", and the "Breastfeeding Intention Scale for Pregnant Women Expecting Twins" were applied. A brochure on breastfeeding twin babies prepared by the researcher was distributed to women. In the second interview, the "HAPA Model Postpartum Motivation Interview Scale", the second part of which was the "Personal Information Form", "Breastfeeding Follow-up Form", "Breastfeeding Motivation Scale" and "Postpartum Breastfeeding Self-Efficacy Scale" were applied. In the third meeting, the "Breastfeeding Follow-up Form" was applied. "Breastfeeding Motivation Scale", "Postpartum Breastfeeding Self-Efficacy Scale" and "Breastfeeding Follow-up Form" were applied in the fourth and fifth interviews, and "Breastfeeding Follow-up Form" was applied in the sixth interview. | Other | Breastfeeding Education |
Primary outcome
Breastfeeding duration of twin babies until the sixth month postpartum after counseling
Time frame: Postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months
The duration of breastfeeding the twins was measured using a breastfeeding follow-up form after the counseling intervention using motivational interviewing techniques. The breastfeeding follow-up form included questions about the number of breastfeedings in the last 24 hours and the mothers' formula feeding status. Mothers who breastfed 9-12 times were considered to have breastfed their babies sufficiently. Mothers who breastfed their babies 6 times or less did not breastfeed their babies enough. Babies of mothers who give formula to their babies are interpreted as not receiving enough breast milk.
5 secondary outcomes
Duration of exclusive breastfeeding of twin babies after consultation until the sixth month after birth
Time frame: postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months
Breastfeeding Intention Level
Time frame: In the prenatal period between 28-38 weeks of gestation
Prenatal Breastfeeding Self Efficacy Level
Time frame: In the Prenatal period between 28-38 weeks of gestation
Postnatal Breastfeeding Self Efficacy Scale Level
Time frame: Postpartum 1-3 days, postpartum 4-6 weeks, and postpartum 4th month.
Breastfeeding Motivation Level in Mothers of Twin Babies
Time frame: 1-3 days postpartum, 4-6 weeks postpartum, and 4th month postpartum
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 Sep 2024.
- Individual participant dataSharing planned: Yes. Participant data will be shared with other researchers after the study is published (after 6 months).
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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.
Oya Kavlak, Prof. Dr. study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Breast Feeding, run by Ege University 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 6 inclusion and 6 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 Sep 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?
Breastfeeding duration of twin babies until the sixth month postpartum after counseling (time frame: Postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2024.