BreastfeedingNCT03807726
Empower Breastfeeding Education Program
A study testing Simulation breastfeeding education in people with Breastfeeding, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Simulation breastfeeding education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 18 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Chronic medical conditions. Abnormal fetal screening. Preterm delivery before 37 weeks gestational weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empower Breastfeeding: Effects of an Integrated Breastfeeding Education Program on Optimal Breastfeeding Practice
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.
Read the 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.
- Conditions
- Breastfeeding
- Being tested
- Simulation breastfeeding education
- Keywords
- Breastfeeding, self-efficacy, education, intervention
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation breastfeeding educationBehavioural
Also called Breastfeeding mindfulness training, Postpartum professional and partner support
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Simulation breastfeeding education |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline Breastfeeding self-efficacy at 6 months.
Secondary outcomes (4)
Exclusive breastfeeding rates
The primary outcomes for this trial are commonly used breastfeeding indicators
Measured: Change from Baseline Exclusive breastfeeding rates at 6 months.
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.
Measured: Change from Baseline Anxiety symptoms at 6 months.
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%.
Measured: Change from Baseline Depressive symptoms at 6 months.
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.
Measured: Change from Baseline Mindful awareness at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Aug 2017
- Primary completion18 May 2019
- Study completion18 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Yu Kuo, Doctoral, Principal investigator, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807726
- Sponsor's protocol ID
- N201701060
- Status last verified
- Apr 2018
- First submitted
- 10 Sep 2018
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32961461
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empower Breastfeeding: Effects of an Integrated Breastfeeding Education Program on Optimal Breastfeeding Practice
- ClinicalTrials.gov ID
- NCT03807726
- Acronym / sponsor ID
- N201701060
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, self-efficacy, education, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 18 May 2019 (actual)
- Study completion
- 18 May 2019 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Simulation breastfeeding educationBoth 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Chronic medical conditions. Abnormal fetal screening. Preterm delivery before 37 weeks gestational weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation breastfeeding educationAlso: Breastfeeding mindfulness training, Postpartum professional and partner supportThe 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. | Behavioural | Intervention Group |
Primary outcome
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
4 secondary outcomes
Exclusive breastfeeding rates
Time frame: Change from Baseline Exclusive breastfeeding rates at 6 months.
Anxiety symptoms
Time frame: Change from Baseline Anxiety symptoms at 6 months.
Depressive symptoms
Time frame: Change from Baseline Depressive symptoms at 6 months.
Mindful awareness
Time frame: Change from Baseline Mindful awareness at 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Derived from this study: PubMed 32961461Tseng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Yu Kuo, Doctoral principal investigator
Taipei Medical University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation breastfeeding education in people with Breastfeeding, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding self-efficacy (time frame: Change from Baseline Breastfeeding self-efficacy at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03807726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.