BreastfeedingNCT05781477
Effect of Breastfeeding Training Program and System (BMUM) for Mothers
A study testing Bmum supportive system in people with Breastfeeding, run by Kastamonu University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of the study was to investigate effect of breastfeeding training program and nurse-led breastfeeding online counselling system (BMUM) on mothers' breastfeeding self-efficacy, breastfeeding attitudes, breastfeeding problems and postpartum depression we hypothesized that there would be differences between BG… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Bmum supportive system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Jun 2020to 15 Jul 2022
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old,
- Primipara with a singleton pregnancy
- 32- and 37-weeks of gestation,
- Willingness to participate in the workshop program
Who cannot join
- Having a chronic illness
- Having pre-term labor or an abnormal fetal screening
- Had a psychiatric disorder or anxiety disorder
- Having any other high-risk complications
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kastamonu University
Merkez, Kastamonu, 37150
Şahika Şimşek Çetinkaya
Merkez, Kastamonu, 37150
About this study
Official title: Effect of Breastfeeding Training Program and Nurse-led Breastfeeding Online Counselling System (BMUM) for Mothers: Randomized Controlled Study
The goal of the study was to investigate effect of breastfeeding training program and nurse-led breastfeeding online counselling system (BMUM) on mothers' breastfeeding self-efficacy, breastfeeding attitudes, breastfeeding problems and postpartum depression we hypothesized that there would be differences between BG and CG groups in terms of breastfeeding self-efficacy, breastfeeding problems, postpartum depression and breastfeeding frequency. This was a randomized controlled trial. Participants were randomly assigned to the breastfeeding group (BG; n = 36), or control group (CG; n = 36). Control group will receive only standart care breastfeeding group will receive standart care and web based breastfeeding support. Breastfeeding attitudes, infant feeding attitude breastfeeding problems and postpartum depression will assessment. The assesment point will be 32-37 gestational week, postpartum 1st day, 1st week, 3 months, and 6 months.
- Conditions
- Breastfeeding
- Being tested
- Bmum supportive system
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bmum supportive systemBehavioural
Bmum is a web-based online tracking system that aims to improve positive attitude about breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Bmum GROUP | Experimental | Mothers in this group were given supportive breastfeeding support with web based Receives: Behavioral: Bmum supportive system |
| control group | No intervention | Mothers in the control and intervention groups were given standard care based on the Baby-Friendly Hospital Intervention Standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self efficacy change on five points between groups
Breastfeeding Self efficacy short form scale will use to assessment breasfeeding self efficacy. Total scores vary from 14 to 70, with higher scores indicating greater self-efficacy
Measured: 32-37 weeks 1st. day 1. week 3rd months 6th months
Infant feeding attitude change on five points between groups
Iowa Infant Feeding Attitude Scale (IIFAS) will use to assessment infant feeding attitude Higher scores indicate a more favorable attitude toward newborn feeding
Measured: 32-37 weeks 1st. day 1. week 3rd months 6th months
Postpartum depression change on four points between groups.
Edinburgh Postnatal Depression Scale (EPDS) will use to assesment postpartum depression. The total score ranges from 0 to 30, with higher scores suggesting a higher level of depression symptoms.
Measured: 1st. day 1st. week 3rd months 6th months
breast problems between two groups on 1 st week
breast problem will assesment with breastfeeding problems questionnaire. number and percent will use to evaluate.
Measured: 1st week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start20 Jun 2020
- Primary completion20 Nov 2020
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şahika ŞİMŞEK ÇETİNKAYA, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781477
- Sponsor's protocol ID
- 4-6/16.06.2020
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breastfeeding Training Program and Nurse-led Breastfeeding Online Counselling System (BMUM) for Mothers: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05781477
- Acronym / sponsor ID
- 4-6/16.06.2020
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 23 Mar 2023 (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.
The goal of the study was to investigate effect of breastfeeding training program and nurse-led breastfeeding online counselling system (BMUM) on mothers' breastfeeding self-efficacy, breastfeeding attitudes, breastfeeding problems and postpartum depression we hypothesized that there would be differences between BG and CG groups in terms of breastfeeding self-efficacy, breastfeeding problems, postpartum depression and breastfeeding frequency. This was a randomized controlled trial. Participants were randomly assigned to the breastfeeding group (BG; n = 36), or control group (CG; n = 36). Control group will receive only standart care breastfeeding group will receive standart care and web based breastfeeding support. Breastfeeding attitudes, infant feeding attitude breastfeeding problems and postpartum depression will assessment. The assesment point will be 32-37 gestational week, postpartum 1st day, 1st week, 3 months, and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bmum GROUP | Experimental | Behavioral: Bmum supportive systemMothers in this group were given supportive breastfeeding support with web based |
| control group | No intervention | –Mothers in the control and intervention groups were given standard care based on the Baby-Friendly Hospital Intervention Standard. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-35 years old,
- Primipara with a singleton pregnancy
- 32- and 37-weeks of gestation,
- Willingness to participate in the workshop program
Key exclusion criteria (4 listed)
- Having a chronic illness
- Having pre-term labor or an abnormal fetal screening
- Had a psychiatric disorder or anxiety disorder
- Having any other high-risk complications
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 |
|---|---|---|
| Bmum supportive systemBmum is a web-based online tracking system that aims to improve positive attitude about breastfeeding | Behavioural | Bmum GROUP |
Primary outcome
Breastfeeding Self efficacy change on five points between groups
Time frame: 32-37 weeks 1st. day 1. week 3rd months 6th months
Breastfeeding Self efficacy short form scale will use to assessment breasfeeding self efficacy. Total scores vary from 14 to 70, with higher scores indicating greater self-efficacy
Infant feeding attitude change on five points between groups
Time frame: 32-37 weeks 1st. day 1. week 3rd months 6th months
Iowa Infant Feeding Attitude Scale (IIFAS) will use to assessment infant feeding attitude Higher scores indicate a more favorable attitude toward newborn feeding
Postpartum depression change on four points between groups.
Time frame: 1st. day 1st. week 3rd months 6th months
Edinburgh Postnatal Depression Scale (EPDS) will use to assesment postpartum depression. The total score ranges from 0 to 30, with higher scores suggesting a higher level of depression symptoms.
breast problems between two groups on 1 st week
Time frame: 1st week
breast problem will assesment with breastfeeding problems questionnaire. number and percent will use to evaluate.
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 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bmum supportive system in people with Breastfeeding, run by Kastamonu University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 4 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 change on five points between groups (time frame: 32-37 weeks 1st. day 1. week 3rd months 6th months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.