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Empower Breastfeeding Education Program

NCT ID: NCT03807726

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-05-18

Brief Summary

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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

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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.

Conditions

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Breastfeeding

Keywords

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Breastfeeding, self-efficacy, education, intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Simulation breastfeeding education

Intervention Type 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Breastfeeding mindfulness training Postpartum professional and partner support

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu-Yu Kuo, Doctoral

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 32961461 (View on PubMed)

Other Identifiers

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N201701060

Identifier Type: -

Identifier Source: org_study_id