Empower Breastfeeding Education Program

Breastfeeding Clinical Trial

Official title:

Empower Breastfeeding: Effects of an Integrated Breastfeeding Education Program on Optimal Breastfeeding Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807726
• Other study ID #: N201701060
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 18, 2019

Study information

• Verified date: April 2018
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To achieve optimal breastfeeding practice, the development of an integrated breastfeeding education program (IBEP) which incorporates simulation education, mindfulness training, professional support targeting the self-efficacy of participants is of vital importance. A randomized controlled trial of an integrated breastfeeding education program focusing on participants will be designed with two study objectives: 1) to evaluate the effects of IBEP on the primary outcome measures of breastfeeding practice as following: a) early initiation of breastfeeding, b) exclusive breastfeeding rate, c) predominate breastfeeding rate; 2) to examine the effects of IBEP on the secondary outcome measures, psychosocial correlates of exclusive breastfeeding including a) breastfeeding self-efficacy, b)anxiety, c) depression, d) mindful awareness e) infant feeding attitude. These objectives will be examined among participants in six time periods: a) during pregnancy 24 to 32 weeks education program b) 34 to 40 weeks of pregnancy (after class or third trimester), c)1 week, d) 4weeks, d) 3 months, e) 6 months postpartum, while the indicators of breastfeeding practice will be examined at the four periods following delivery.

It is hypothesized that 1) the intervention will result in a better effect on all primary outcome measures, as compared to those in the control group. Specifically, participants in IBEP group will show 10 % or greater difference in exclusive breastfeeding rates at six months than participants in the control group, 2) participants in the IBEP group will demonstrate larger effects on breastfeeding self-efficacy and mindfulness, and lower anxiety and depression than those in the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: May 18, 2019
• Est. primary completion date: May 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Simulation breastfeeding education
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University, Taiwan, R.O.C.	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Exclusive breastfeeding rates	The primary outcomes for this trial are commonly used breastfeeding indicators	Change from Baseline Exclusive breastfeeding rates at 6 months.
Secondary	Anxiety symptoms	Anxiety symptoms of mother and her partner will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI). The 20 item questionnaire contains a 4-point likert scale of 1 (not at all) to 4 (very much so), with an overall score ranging 20-80. A higher score indicates higher anxiety.	Change from Baseline Anxiety symptoms at 6 months.
Secondary	Depressive symptoms	The Taiwanese version of the Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms among new mother and father. EPDS has been used and tested in father participants with good validity. It is a 10-item self-reported questionnaire with a 4-point scale that ranges from 0 ("no") to 3 ("most of the time"), with a total score ranging 0~30. A higher score represents a higher level of depression. The suggested cutoff of 12/13 was used to detect probable cases of clinical depression, with a respective sensitivity and specificity of 83% and 89%.	Change from Baseline Depressive symptoms at 6 months.
Secondary	Mindful awareness	The Five Facet Mindfulness Questionnaire at baseline, 1, 3 and 6 months The Taiwanese version of the Five Facet Mindfulness Questionnaire (FFMQ) will be adopted to assess new mothers' and partners mindfulness. The FFMQ has been translated into Chinese. It is a 39-item self-reported questionnaire with a 5-point scale that ranges from 1 (almost not) to 5 (almost always). A higher score represents a higher level of mindfulness.	Change from Baseline Mindful awareness at 6 months.