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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Istanbul, Turkey
        • Marmara University School of medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
at 6 months
Total breastfeeding duration
Time Frame: at 12 months
Total breastfeeding duration will be asked with a single question at 12 months
at 12 months
Total breastfeeding duration
Time Frame: at 24 months
Total breastfeeding duration will be asked with a single question at 12 months
at 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline (postpartum 1st month) and 5 months after (at 6th Month)
Change in Paternal-Infant Attachment
Time Frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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.
Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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.
Baseline (postpartum 1st month) and 5 months after (at 6th Month)
Change in Marital Adjustment
Time Frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)
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.
Baseline (postpartum 1st month) and 5 months after (at 6th Month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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