Clinical trial NCT05109988: Father-involvement Telephone Support Intervention on Breastfeeding: RCT
Official title: The Effect of a Father-involvement Breastfeeding Telephone Support Intervention on Exclusive and Sustained Breastfeeding: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Feeding, Exclusive
Parents
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of exclusive breastfeeding
timeFrame: 1 month
Secondary outcomes:
measure: Prevalence of exclusive breastfeeding
timeFrame: 2 months
measure: Prevalence of exclusive breastfeeding
timeFrame: 4 months
measure: Prevalence of exclusive breastfeeding
timeFrame: 6 months
measure: Duration of exclusive breastfeeding
timeFrame: 1 month
measure: Duration of exclusive breastfeeding
timeFrame: 2 months
measure: Duration of exclusive breastfeeding
timeFrame: 4 months
measure: Duration of exclusive breastfeeding
timeFrame: 6 months
measure: Edinburgh Postnatal Depression Scale
timeFrame: 2 months
measure: Edinburgh Postnatal Depression Scale
timeFrame: 6 months
measure: Postpartum Bonding Questionnaire
timeFrame: 2 months
measure: Postpartum Bonding Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Ngai Fei Wan
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Fei Wan Ngai, PhD
role: PRINCIPAL_INVESTIGATOR
References: