Father-involvement Telephone Support Intervention on Breastfeeding: RCT

Parents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05109988
• Other study ID #: 18191141
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: January 28, 2025

Study information

• Verified date: May 2023
• Source: The Hong Kong Polytechnic University
• Contact: Fei Wan Ngai, PhD
• Phone: 852 2766 6775
• Email: vivian.ngai[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 738
• Est. completion date: January 28, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• Parents

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Ngai Fei Wan	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postpartum Bonding Questionnaire	to assess parent-infant relationship	2 months
Secondary	Postpartum Bonding Questionnaire	to assess parent-infant relationship	6 months