Empower Breastfeeding Education Program

NCT03807726 | Completed DMC

• 1 other identifier: N201701060
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This study results of integrated breastfeeding education program (IBEP) will guide in designing a theory-based breastfeeding educational module on promotion of optimal breastfeeding practice in new mother and her partner. The current novel education curriculum incorporated breastfeeding simulation, mindfulness training, and professional support will provide important information in supporting use of IBEP in enhancing participants self-efficacy. This study will show on how simulation teaching and mindfulness training can be utilized in the field of perinatal teaching to achieve better health outcomes.

Conditions

Breastfeeding

Keywords

Breastfeeding, self-efficacy, education, intervention

Outcome Measures

Primary Outcomes (1)

• Breastfeeding self-efficacy

  The Taiwanese version of the Breastfeeding Self-Efficacy Scale -Short form (BSES-SF) will be used to measure new mothers and father's breastfeeding self-efficacy. The mother breastfeeding self-efficacy was referred as a mother's confidence in her ability to breastfeed her infant, while the paternal breastfeeding self-efficacy was measured the father's confidence in his ability to support mothers' breastfeeding. The fathers version has been used previously. The BSES was originally developed by Dennis and Faux (1999) and has been translated into Chinese. It is a 14-item self-reported questionnaire with a 5-point scale that ranges from 1 to 5, with a total score ranging 5\~70. A higher score represents a higher level of self-efficacy.The primary outcomes for this trial are commonly used breastfeeding indicators

  Change from Baseline Breastfeeding self-efficacy at 6 months.

Secondary Outcomes (4)

• Exclusive breastfeeding rates

  Change from Baseline Exclusive breastfeeding rates at 6 months.

• Anxiety symptoms

  Change from Baseline Anxiety symptoms at 6 months.

• Depressive symptoms

  Change from Baseline Depressive symptoms at 6 months.

• Mindful awareness

  Change from Baseline Mindful awareness at 6 months.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Both standard usual care and the integrated breastfeeding education program (IBEP) will be provided to the participants in the intervention group. The integrated interventions are consisted of 1) four sessions of simulation breastfeeding education to build up the participants' performance accomplishment and vicarious learning including breastfeeding knowledge, skill, and self-efficacy; 2) two sessions of breastfeeding mindfulness training to equip women and their partners with stress reduction skills for their emotional arousal during breastfeeding; 3) a series of postpartum professional support to offer verbal persuasion in enhancing their breastfeeding skills and levels of self-efficacy. The details of each education components are presented at the following section.

Behavioral: Simulation breastfeeding education

Control Group

NO INTERVENTION

The mother and her partner in the control group will receive the standard usual care provided at the study site. The study site hospital where follows the 10 steps of the Baby Friendly Hospital Initiative will provide breastfeeding care during prenatal check-up and postpartum care. The standard care protocols encompass elements such as prenatal breastfeeding consultation using breastfeeding pamphlets, and postpartum care like skin to skin contact, rooming- in, and breastfeeding consultation using pamphlets. The pregnant women need to register for childbirth class which contains only one breastfeeding class by themselves if needed. After delivery, the mothers are taught on breastfeeding knowledge and skills by the nurses at the postpartum ward or nursey.

Interventions

Simulation breastfeeding education BEHAVIORAL

The integrated interventions are consisted of 1) four sessions of simulation breastfeeding education to build up the participants' performance accomplishment and vicarious learning including breastfeeding knowledge, skill, and self-efficacy; 2) two sessions of breastfeeding mindfulness training to equip women and their partners with stress reduction skills for their emotional arousal during breastfeeding; 3) a series of postpartum professional support to offer verbal persuasion in enhancing their breastfeeding skills and levels of self-efficacy.

Also known as: Breastfeeding mindfulness training, Postpartum professional and partner support

Intervention Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20 years and above. During the first or second trimester of pregnancy. Willing to breastfeed after delivery Singleton pregnancy. Participants are able to attend the breastfeeding class.

You may not qualify if:

• Chronic medical conditions. Abnormal fetal screening. Preterm delivery before 37 weeks gestational weeks.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University, Taiwan, R.O.C.

Taipei, Taiwan

Location

Related Publications (1)

• Tseng JF, Chen SR, Au HK, Chipojola R, Lee GT, Lee PH, Shyu ML, Kuo SY. Effectiveness of an integrated breastfeeding education program to improve self-efficacy and exclusive breastfeeding rate: A single-blind, randomised controlled study. Int J Nurs Stud. 2020 Nov;111:103770. doi: 10.1016/j.ijnurstu.2020.103770. Epub 2020 Sep 3.

  PMID: 32961461 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Shu-Yu Kuo, Doctoral

  Taipei Medical University, Taiwan, R.O.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Eligible participants will be randomly assigned to either intervention group or control group. A permuted block randomization method will be used to ensure equal number of subjects in each group. A block size of 4 including 6 different combinations, i.e., AABB, ABAB, ABBA, BBAA, BABA, and BAAB will be adopted. The sequence of block number will be generated randomly by the computer and then apply to the first four subjects and so on. The allocation concealment will be maintained by using opaque sealed envelopes containing the sequence number and will be prepared by the researcher who is not involved in participants' recruitment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-blind randomized controlled trial with a two-arm design will be conducted among new mothers and their partners. The objectives are to determine whether an integrated breastfeeding education program based on breastfeeding self-efficacy theory \[28, 31\] will increase exclusive breastfeeding duration among women and psychological correlates of exclusive breastfeeding. This is a novel educational intervention incorporated simulation-based courses, mindfulness training, and professional support for targeting mother and her partner's self-efficacy enhancement.

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: January 17, 2019
• Study Start: August 1, 2017
• Primary Completion: May 18, 2019
• Study Completion: May 18, 2019
• Last Updated: December 23, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)