NCT04798872

Brief Summary

Background: Maternal and paternal breastfeeding self-efficacy is an important factor and could be modified in improving breastfeeding outcomes. Conducting breastfeeding educational intervention that involves the husband as well as incorporating a web-based platform based on breastfeeding self-efficacy theory is needs to be explored. Objectives: The aim to investigate the effectiveness of the web-based educational intervention on breastfeeding self-efficacy and breastfeeding outcomes. Methods: A randomized control trial will be conducted to investigate the effectiveness of the web-based educational intervention on breastfeeding self-efficacy and breastfeeding outcomes. 80 mothers and fathers from primary health care and public hospital in Jakarta will be recruited in this study and will randomly allocate using block randomization. The participants in the intervention group will receive standard usual care and web-based educational intervention, while the control group will receive usual care. The outcomes of this study are breastfeeding self-efficacy, depression, anxiety, infant feeding attitude, as well as breastfeeding outcomes that will be measured at baseline, 38 weeks of pregnancy, 1 week, 1, 3, and 6 months. A generalized Linear Model will be used to test the effect of the intervention for the group, time as well as group and time interaction. Anticipatory result:The educational intervention will be effective in helping mothers and fathers receiving interventions to have higher breastfeeding self-efficacy, lower levels of depression and anxiety, higher breastfeeding attitude as well as exclusive breastfeeding rate compared to mothers and fathers in the control group. Keywords: Breastfeeding self-efficacy, breastfeeding, web-based, reliability, validity, Indonesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
448

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

April 6, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

February 18, 2021

Last Update Submit

February 25, 2022

Conditions

Keywords

web-based interventionbreastfeedingself efficacyinfant feeding behavior

Outcome Measures

Primary Outcomes (6)

  • Maternal breastfeeding self and paternal breastfeeding self-efficacy

    confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.

    baseline

  • Maternal breastfeeding self and paternal breastfeeding self-efficacy

    confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.

    38 weeks of pregnancy

  • Maternal breastfeeding self and paternal breastfeeding self-efficacy

    confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.

    1 week after delivery

  • Maternal breastfeeding self and paternal breastfeeding self-efficacy

    confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.

    1 months after delivery

  • Maternal breastfeeding self and paternal breastfeeding self-efficacy

    confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.

    3 months after delivery

  • Maternal breastfeeding self and paternal breastfeeding self-efficacy

    confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.

    6 months after delivery

Secondary Outcomes (4)

  • Depression

    baseline, 38 weeks of pregnancy, 1 week, 1, 3, and 6 months after delivery

  • Anxiety

    baseline, 38 weeks of pregnancy, 1 week, 1, 3, and 6 months after delivery

  • Iowa Infant Feeding Attitude Scale (IIFAS)

    baseline, 38 weeks of pregnancy, 1 week, 1, 3, and 6 months after delivery

  • Breastfeeding rate

    1 week, 1, 3, and 6 months of infant age

Study Arms (2)

web-based educational program

EXPERIMENTAL

Consist of 6 education session during 1 month and will be followed up by telephone counselling at 2, 4, and 6 weeks postpartum.

Other: Web-based educational program

control (usual care)

NO INTERVENTION

Mothers in the control group will receive standard treatment with pamphlets during the prenatal period. After delivery, standard postpartum care will be provided by the midwife, including pamphlets, rooming in and encourage mothers to breastfeed the baby.

Interventions

The mothers and fathers will be provided a website that consist of 6 session. at the end of the session, the lactation consultant will do video call to the mothers to discuss the questions from mothers and fathers. after delivery, telephone counseling will be conducted by lactation consultant to mothers at 2, 4, and 6. weeks postpartum

web-based educational program

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous with singleton pregnancy at 12-34 weeks' gestation
  • Age ≥ 20 years
  • Plan to breastfeed the infant
  • The husband willing to participate in the educational program
  • Capable to use a cell phone
  • Can access the internet .Fluent in reading and writing Bahasa.

You may not qualify if:

  • Presence of congenital anomaly for the baby .Chronic disease or high-risk complications during pregnancy and after delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jakarta Primary Health Center and Public General Hospital under Health Department of Jakarta Province Government

Jakarta, DKI Jakarta, 10160, Indonesia

Location

MeSH Terms

Conditions

Breast FeedingFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to participants allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study consist of two groups: intervention and control group. Mothers and fathers in intervention group will be provided web-based educational program and mothers and fathers in control group will be provided usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 18, 2021

First Posted

March 15, 2021

Study Start

April 6, 2021

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations