NCT05064982

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 16, 2021

Last Update Submit

September 23, 2021

Conditions

Keywords

depressionbreastfeedingpaternal depressionpaternal involvementmarital relationship

Outcome Measures

Primary Outcomes (3)

  • Exclusive breastfeeding duration

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

    at 6 months

  • Total breastfeeding duration

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

    at 12 months

  • Total breastfeeding duration

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

    at 24 months

Secondary Outcomes (4)

  • Change in perceived paternal breastfeeding support

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

  • Change in Paternal-Infant Attachment

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

  • Change in paternal depression

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

  • Change in Marital Adjustment

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

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsFathers
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingDepression

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorBehavioral Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 1, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2023

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations