Clinical trial NCT03807726: Empower Breastfeeding Education Program
Official title: Empower Breastfeeding: Effects of an Integrated Breastfeeding Education Program on Optimal Breastfeeding Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding, self-efficacy, education, intervention
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Breastfeeding self-efficacy
timeFrame: Change from Baseline Breastfeeding self-efficacy at 6 months.
Secondary outcomes:
measure: Exclusive breastfeeding rates
timeFrame: Change from Baseline Exclusive breastfeeding rates at 6 months.
measure: Anxiety symptoms
timeFrame: Change from Baseline Anxiety symptoms at 6 months.
measure: Depressive symptoms
timeFrame: Change from Baseline Depressive symptoms at 6 months.
measure: Mindful awareness
timeFrame: Change from Baseline Mindful awareness at 6 months.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University, Taiwan, R.O.C.
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Shu-Yu Kuo, Doctoral
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.