Father-involvement Telephone Support Intervention on Breastfeeding: RCT

The Effect of a Father-involvement Breastfeeding Telephone Support Intervention on Exclusive and Sustained Breastfeeding: A Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Parents; Breast Feeding, Exclusive
• Intervention / Treatment: Behavioral: Breastfeeding telephone support

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 738
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fei Wan Ngai, PhD; Phone Number: 6775 852 2766 6775; Email: vivian.ngai@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Ngai Fei Wan
    • Contact: Fei Wan Ngai, PhD; Phone Number: 6775 852 2766 6775; Email: vivian.ngai@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Control; Standard postpartum care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of exclusive breastfeeding	The prevalence/proportion of infants younger than 1 month who are exclusively breastfed is calculated as the number of infants younger than 1 month who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 1 month.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of exclusive breastfeeding	The prevalence of infants younger than 1 month who are exclusively breastfed is calculated as the number of infants younger than 1 month who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 1 month.	2 months
Prevalence of exclusive breastfeeding	The prevalence of infants younger than 4 months who are exclusively breastfed is calculated as the number of infants younger than 4 months who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 4 months.	4 months
Prevalence of exclusive breastfeeding	The prevalence of infants younger than 6 months who are exclusively breastfed is calculated as the number of infants younger than 6 months who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 6 months.	6 months
Duration of exclusive breastfeeding	The duration of exclusive breastfeeding is measured as the infant's age in weeks when the women first introduce infant formula.	1 month
Duration of exclusive breastfeeding	The duration of exclusive breastfeeding is measured as the infant's age in weeks when the women first introduce infant formula.	2 months
Duration of exclusive breastfeeding	The duration of exclusive breastfeeding is measured as the infant's age in weeks when the women first introduce infant formula.	4 months
Duration of exclusive breastfeeding	The duration of exclusive breastfeeding is measured as the infant's age in weeks when the women first introduce infant formula.	6 months
Edinburgh Postnatal Depression Scale	The Edinburgh Postnatal Depression Scale is a 10-item self-report instrument used to assess the presence of depressive symptoms during the postnatal period. Each item is scored on a 4-point scale and total scores ranging from 0 to 30, with higher scores indicating more depressive symptoms.	2 months
Edinburgh Postnatal Depression Scale	The Edinburgh Postnatal Depression Scale is a 10-item self-report instrument used to assess the presence of depressive symptoms during the postnatal period. Each item is scored on a 4-point scale and total scores ranging from 0 to 30, with higher scores indicating more depressive symptoms.	6 months
Postpartum Bonding Questionnaire	to assess parent-infant relationship	2 months
Postpartum Bonding Questionnaire	to assess parent-infant relationship	6 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Fei Wan Ngai, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): January 28, 2025

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18191141

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