Empower Breastfeeding Education Program
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|ClinicalTrials.gov Identifier: NCT03807726|
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding||Behavioral: Simulation breastfeeding education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking Description:||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.|
|Primary Purpose:||Supportive Care|
|Official Title:||Empower Breastfeeding: Effects of an Integrated Breastfeeding Education Program on Optimal Breastfeeding Practice|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||May 18, 2019|
|Estimated Study Completion Date :||May 18, 2019|
Experimental: 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.
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.
No Intervention: 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.
- Early initiation of breastfeeding rates [ Time Frame: Early initiation of breastfeeding within 24 hours after delivery. ]The primary outcomes for this trial are commonly used breastfeeding indicators
- Exclusive breastfeeding rates [ Time Frame: Change from Baseline Exclusive breastfeeding rates at 6 months. ]The primary outcomes for this trial are commonly used breastfeeding indicators
- Predominate breastfeeding rates [ Time Frame: Change from Baseline Predominate breastfeeding rates at 6 months ]The primary outcomes for this trial are commonly used breastfeeding indicators
- 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.
- Anxiety symptoms [ Time Frame: Change from Baseline Anxiety symptoms at 6 months. ]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.
- Depressive symptoms [ Time Frame: Change from Baseline Depressive symptoms at 6 months. ]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%.
- Mindful awareness [ Time Frame: Change from Baseline Mindful awareness at 6 months. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807726
|Contact: Shu-Yu Kuo, Doctoral||886-02-2736-1661 ext email@example.com|
|Contact: KuanChing Wu, BSN||886-02-2736-1661 ext firstname.lastname@example.org|
|Taipei Medical University, Taiwan, R.O.C.||Recruiting|
|Contact: Shu-Yu Kuo, Doc 02-2736-1661 ext 6308 email@example.com|
|Contact: KuanChing Wu, BSN 02-2736-1661 ext 6308 firstname.lastname@example.org|
|Principal Investigator:||Shu-Yu Kuo, Doctoral||Taipei Medical University, Taiwan, R.O.C.|