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Clinical Trials/NCT03807726
NCT03807726
Completed
Not Applicable

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

Taipei Medical University1 site in 1 country800 target enrollmentAugust 1, 2017
ConditionsBreastfeeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Taipei Medical University
Enrollment
800
Locations
1
Primary Endpoint
Breastfeeding self-efficacy
Status
Completed
Last Updated
6 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
May 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Breastfeeding self-efficacy

Time Frame: Change from Baseline Breastfeeding self-efficacy at 6 months.

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

Secondary Outcomes

  • Depressive symptoms(Change from Baseline Depressive symptoms at 6 months.)
  • Mindful awareness(Change from Baseline Mindful awareness at 6 months.)
  • Exclusive breastfeeding rates(Change from Baseline Exclusive breastfeeding rates at 6 months.)
  • Anxiety symptoms(Change from Baseline Anxiety symptoms at 6 months.)

Study Sites (1)

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