- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05064982
Paternal Involvement in Breastfeeding
September 23, 2021 updated by: Perran Boran, Marmara University
The Impact of Paternal Involvement on Breastfeeding
Paternal involvement in breastfeeding has been identified as a significant predictor in maternal breastfeeding outcomes.
The main aim of this study is to examine the relationship between reported paternal breastfeeding support and paternal-infant attachment with exclusive breastfeeding and total breastfeeding duration.
The hypothesis is that paternal involvement in breastfeeding increase exclusive breastfeeding rates, total breastfeeding duration and strengthen paternal-infant attachment.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Initiation, duration and exclusivity of breastfeeding are greatly influenced by paternal involvement in breastfeeding.
Previous studies showed that fathers who are involved in the breastfeeding process have stronger attachments with their babies.
However, research on fathers' involvement in their partners' breastfeeding is lacking and there are no comprehensive studies conducted on the effects of the paternal involvement and infant attachment on exclusive breastfeeding (EB) and total breastfeeding duration.
Therefore, the aim of the study is to examine the relationship between fathers reported breastfeeding support and paternal-infant attachment with exclusive breastfeeding and total breastfeeding duration.
Data will be collected from a tertiary university hospital.
The study will be conducted in two phases.
In the first phase, the researcher will approach healthy, term, one month old babies and their fathers who fulfilled the eligibility criteria and will invite them to participate in the study.
Informed consent will be obtained from participating fathers.
The Partner Breastfeeding Influence scale will be used to measure fathers' involvement in their partner's breastfeeding, Paternal-infant attachment, paternal depression, and marital adjustment will be measured with Paternal-Infant Attachment Questionnaire, Edinburgh Postpartum Depression Scale and Marital Adjustment Scale respectively.
Four sets of questionnaires will be administered at two time points for the study.
The first set will be administered at postpartum first month.
The second set of data will be collected at postpartum six months.
In the second phase, fathers participating in the study will be interviewed for breastfeeding duration and factors associated with cessation will be explored at postpartum 12 and 24 months.
Study Type
Observational
Enrollment (Anticipated)
230
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Marmara University School of medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Fathers of one-month-old, term, healthy, breastfed infants
Description
Inclusion Criteria:
Fathers of
- one-month-old,
- healthy,
- breastfed infants
Exclusion Criteria:
- Infants with a birth weight less than 2500 grams
- Infants who are less than 37 weeks gestation
- Infants with prenatally suspected or diagnosed congenital defects
- Parents with major depression
- Divorced or separated couples
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exclusive breastfeeding duration
Time Frame: at 6 months
|
Exclusive breastfeeding duration will be asked with a single question at six months
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at 6 months
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Total breastfeeding duration
Time Frame: at 12 months
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Total breastfeeding duration will be asked with a single question at 12 months
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at 12 months
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Total breastfeeding duration
Time Frame: at 24 months
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Total breastfeeding duration will be asked with a single question at 12 months
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at 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perceived paternal breastfeeding support
Time Frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)
|
The Partner Breastfeeding Influence Scale (PBIS) will be used to measure perceived breastfeeding support and will be assessed using five dimensions of partner breastfeeding support.
These are Savvy, helping, appreciation, breastfeeding presence, and responsiveness.
Mean scores are calculated from all questions, from 1 (extremely not supportive) to 5 (extremely supportive) for each breastfeeding support component.
High scores show that breastfeeding support of father is notable.
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Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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Change in Paternal-Infant Attachment
Time Frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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The Paternal-Infant Attachment Scale (PIAS) will be used to measure the strength of the bond between the father and infant.
The PIAS is a scale consisting of 19 items, with every item graded between 1 and 5 points.
High scores show that the attachment is strong.
The gathered score average from PIAS is near the score of 19 (minimum value) show a weak attachment; however, when it is near the score of 95 (the maximum value), show a strong attachment.
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Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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Change in paternal depression
Time Frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)
|
The Edinburgh Postpartum Depression Scale (EPDS) will be used to detect depression as a screening tool.
The EPDS is a ten item self-report questionnaire.
Items 1 and 2 assess anhedonia; item 3: self-blame; item 4: anxiety; item 5: fear or panic; item 6: inability to cope; item 7: difficulty sleeping; item 8: sadness; item 9: tearfulness and item 10: self-harm ideas.
Responses are scored as 0, 1, 2 and 3 according to the increasing severity of the symptoms.
Total score is calculated by adding each score of each 10 items.
The value of score can range from 0 to 30.
The traditional cut-off score for the Edinburgh Postpartum Depression Scale when assessing women is 13 or greater however, a lower cut-off score is recommended for fathers as men express emotions differently from women, mainly that they are less expressive with their negative emotions.
For this study a cut-off score of 10 or above will be used to assess Paternal Postpartum Depression.
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Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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Change in Marital Adjustment
Time Frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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The Marital Adjustment Scale (MAS) consists of 15 items that evaluate general adjustment, conflict resolution, attachment, and communication.
High scores from this scale indicates high marital adjustment.
The value of score can range 0 to 60.
A score of less than a 43 or below reflects marital distress in marital adjustment scale.
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Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2021
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
September 16, 2021
First Submitted That Met QC Criteria
September 23, 2021
First Posted (Actual)
October 1, 2021
Study Record Updates
Last Update Posted (Actual)
October 1, 2021
Last Update Submitted That Met QC Criteria
September 23, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2021.845
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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