CClinicalTrials.gg
Status unknownNCT05064982Updated Oct 1, 2021

Paternal Involvement in Breastfeeding

An observational study in Breastfeeding, Paternal Behavior and Depression, sponsored by Marmara University. Status unknown at 1 site in Turkey. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-01.

Sponsored by Marmara University · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
230
Ages
18 Years to 60 Years
Sex
Male
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Study summary

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.

Read the 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.

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Conditions studied

  • Breastfeeding
  • Paternal Behavior
  • Depression

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Keywords

  • depression
  • breastfeeding
  • paternal depression
  • paternal involvement
  • marital relationship
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 230 is above the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Fathers of one-month-old, term, healthy, breastfed infants

Inclusion criteria

Fathers of

  • one-month-old,
  • healthy,
  • breastfed infants

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
230 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Exclusive breastfeeding duration

    Exclusive breastfeeding duration will be asked with a single question at six months

    Time frame: at 6 months

  2. Total breastfeeding duration

    Total breastfeeding duration will be asked with a single question at 12 months

    Time frame: at 12 months

  3. Total breastfeeding duration

    Total breastfeeding duration will be asked with a single question at 12 months

    Time frame: at 24 months

Secondary outcomes

  1. Change in perceived paternal breastfeeding support

    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.

    Time frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)

  2. Change in Paternal-Infant Attachment

    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.

    Time frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)

  3. Change in paternal depression

    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.

    Time frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)

  4. Change in Marital Adjustment

    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.

    Time frame: Baseline (postpartum 1st month) and 5 months after (at 6th Month)

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Study locations

1 site
  • Marmara University School of Medicine
    Istanbul, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05064982
Lead sponsor
Marmara University
Responsible party
Perran Boran (Professor of Pediatrics, Marmara University) — Principal investigator
First posted
Oct 1, 2021
Start date
Oct 2021 (estimated)
Primary completion
Oct 2022 (estimated)
Completion
Oct 2023 (estimated)
Last update
Oct 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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