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Father-involvement Telephone Support Intervention on Breastfeeding: RCT

NCT ID: NCT05109988

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

649 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-18

Study Completion Date

2025-07-28

Brief Summary

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The World Health Organization advocates for breastfeeding as the best source of food for optimal infant development, which reduces the risk of infant mortality and morbidity. The objectives of this study are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding. The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. We expect that women who receive the intervention will have a higher rate and longer duration of exclusive breastfeeding, fewer depressive symptoms and better parent-child relationship. The knowledge gained from this study can provide direction for the development of flexible, accessible and culturally sensitive interventions to promote breastfeeding and mental health in Chinese society.

Detailed Description

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Exclusive breastfeeding is recommended as the most beneficial form of infant nutrition during the first 6 months of life, which protects infants against childhood illness and reduces the risk of infant mortality and morbidity. The aim of this study is to implement and evaluate a breastfeeding telephone support intervention that involves mothers and fathers during the postpartum period. The objectives are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding.

Hypothesis to be tested:

1. Mothers who receive the father-involvement telephone support intervention will have a higher rate and a longer duration of exclusive breastfeeding at 1, 2, 4 and 6 months postpartum than those who receive the standard postpartum care.
2. Mothers and fathers who receive the intervention will have: (a) fewer depressive symptoms, and (b) better parent-infant bonding at 2 and 6 months postpartum than those who receive the standard postpartum care.

Design and subjects: Randomized controlled trial. A sample of postpartum mothers (n = 738) and fathers (n = 738) will be randomly assigned to either the experimental or the control groups.

Study instruments: Edinburgh Postnatal Depression Scale (EPDS) and Postpartum Bonding Questionnaire (PBQ).

Intervention: The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.

Main outcome measures: The prevalence and duration of exclusive breastfeeding will be collected at 1, 2, 4 and 6 months postpartum. Postnatal depression and parent-infant boding will be assessed by the EPDS and the PBQ, respectively, at 2 and 6 months postpartum.

Data analysis: Generalized linear mixed models and survival analysis will be conducted to compare differences in the outcomes between two groups.

Potential application: The implementation of a simple, brief telephone-based intervention for breastfeeding families is most likely to be taken up in the primary health care setting. The results may better equip policy makers and health professionals to design health promotion programs for breastfeeding families, thus reducing the public health burden of childhood illness.

Conditions

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Breast Feeding, Exclusive Parents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The outcome measures will be collected by a research assistant who is blind to the group allocation.

Study Groups

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Intervention

The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.

Group Type EXPERIMENTAL

Breastfeeding telephone support

Intervention Type BEHAVIORAL

The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.

Control

Standard postpartum care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breastfeeding telephone support

The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* aged 18 years or above;
* giving birth to a single healthy baby at term
* ability to speak and read the Chinese language

Exclusion Criteria

* psychiatric illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Ngai Fei Wan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fei Wan Ngai, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Ngai Fei Wan

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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18191141

Identifier Type: -

Identifier Source: org_study_id