Breast Feeding, ExclusiveNCT05191303
Effectiveness of Mobile Intervention for Breast Feeding Counseling (MIBFc) in Primiparous Mothers
A study testing Mobile intervention of breastfeeding counseling in people with Breast Feeding, Exclusive, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to evaluate the effectiveness of mobile intervention for breastfeeding counseling (MIBFc) to improve exclusive breastfeeding duration among primiparous women in Finland. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Feeding, Exclusive
- What is being tested?
- Mobile intervention of breastfeeding counseling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteFinland
- Study dates
- 4 Apr 2022to 1 Sep 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primiparous women
- 18 years or older
- finnish language
- singleton foetus
- have an intention to breastfeed
- have a smartphone
Who cannot join
- multiple pregnancy
- risk pregnancy, or other disease to be monitored
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
City of Oulu Maternity Clinic
Oulu, 90580
Pirkko Nikula, +358 405145342, pirkko.nikula@oulu.fi
Tarja Pölkki, +358 504280772, tarja.polkki@oulu.fi
About this study
Official title: Developing Mobile Intervention of the Breast Feeding Counseling and Evaluating Its Effectiveness in Primiparous Mothers
The purpose of this study is to evaluate the effectiveness of mobile intervention for breastfeeding counseling (MIBFc) to improve exclusive breastfeeding duration among primiparous women in Finland.
Read the detailed description
The investigators hypothesize that the use of mobile intervention for breastfeeding counseling to primiparous women improve the exclusive breastfeeding rates, breastfeeding attitudes, breastfeeding confidence and the satisfaction of breastfeeding counselling. These outcomes are assumed to be higher in the intervention group than in the control group.
- Conditions
- Breast Feeding, Exclusive
- Being tested
- Mobile intervention of breastfeeding counseling
- Keywords
- Mobile application, Attitude, Confidence, Self, Counseling, Intervention, Randomized controlled trial (RCT), Breast Feeding, exclusive, Primiparous
- Medical subject headings
- Breast Feeding, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile intervention of breastfeeding counselingDevice
The mobile intervention of breastfeeding counseling includes an evidence-based information of breastfeeding, which is based on Ten steps of breastfeeding of Baby Friendly Hospital Initiative (BFHI) and Finnish Institute for Health and Welfare recommendation. The links provide more information and videos related to breastfeeding topic. The mobile intervention of breastfeeding counseling allows the client to write comments or notes that can be used in counseling at maternity clinic or hospital. The mobile intervention of breastfeeding counseling also provides an e-mail to non-urgent questions related to breastfeeding. Questions will be answered within 3 or 4 days by a lactation consultant (IBCLC).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In addition to standard usual care of breastfeeding counseling, the intervention group will have an opportunity to access the mobile application breastfeeding counseling from weeks 18 of pregnancy, continuing for up to 6 months after childbirth. Receives: Device: Mobile intervention of breastfeeding counseling |
| Control group | No intervention | The control group receives the standard usual care of breastfeeding counseling in maternity care and in hospital from weeks 18 of pregnancy, continuing for up to 6 months after childbirth. The standard usual care of breastfeeding follows the 10 steps of the Baby Friendly Hospital Initiative programme and Finnish Institute for Health and Welfare recommendation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding relative rate at 1 months of age
Proportion of infants exclusive breastfeeding at 1 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
Measured: 1 month after childbirth
Exclusive breastfeeding relative rate at 4 months of age
Proportion of infants exclusive breastfeeding at 4 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
Measured: 4 moths after childbirth
Exclusive breastfeeding relative rate at 6 months of age
Proportion of infants exclusive breastfeeding at 6 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
Measured: 6 months after childbirth
Secondary outcomes (5)
The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancy
IIFAS is a 17-items scale developed by De la Mora and Russell (1999) to evaluate maternal attitudes toward infant feeding. The Scale relatively easy to administer and score and it is usable with a wide variety of populations. Scale is 5 point Likert type scale.
Measured: Measurements are made in 18 and 34 weeks of gestation
Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)
Breastfeeding Self-Efficacy Scale-Short Form: It is a 33-item scale developed by Dennis and Faux (1999) to evaluate breastfeeding self-efficacy levels of mothers. Later, a 14-item short form of the scale was developed in 2003 (Dennis 2003). Dennis (2003) recommends this short form for use. It is applied more easily and evaluates self-efficacy correctly. Breastfeeding Self-Efficacy Short Form Scale is a 5 point Likert type scale.
Measured: Measurements are made in 1 and 4 months after childbirth
Satisfaction of breastfeeding guidance
Satisfaction of breastfeeding guidance measured with Visual Analogue Scale (VAS) (numeric 0 to 10)
Measured: Measurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.
Use of infants additional milk at hospital after childbirth
Use of infants additional milk at hospital after childbirth and only medical supplementary milk accepted
Measured: The researcher retrieves the data from the patient record after 6 months of childbirth.
Infants exclusive breastfeeding rate (relative share / portion)
Infants exclusive breastfeeding rate (relative share / portion) when leaving the hospital. Only medical supplementary milk accepted
Measured: The researcher retrieves the data from the patient record after 6 months of childbirth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start4 Apr 2022
- Primary completion31 May 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Feeding, ExclusiveStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind randomized controlled trial with a two-arm design will be conducted among primiparous mothers. Participants are randomized to two groups, a intervention and a control group. Participants receive standard usual care of breastfeeding counselling in both groups. In addition, the intervention group members will use mobile intervention of breastfeeding counseling.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Principal investigator, Pirkko Nikula, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191303
- Sponsor's protocol ID
- 1954032
- Status last verified
- May 2022
- First submitted
- 10 Dec 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Mobile Intervention of the Breast Feeding Counseling and Evaluating Its Effectiveness in Primiparous Mothers
- ClinicalTrials.gov ID
- NCT05191303
- Acronym / sponsor ID
- 1954032
- Conditions
- Breast Feeding, Exclusive
- Keywords
- Mobile application, Attitude, Confidence, Self, Counseling, Intervention, Randomized controlled trial (RCT), Breast Feeding, exclusive, Primiparous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 13 Jan 2022 (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 purpose of this study is to evaluate the effectiveness of mobile intervention for breastfeeding counseling (MIBFc) to improve exclusive breastfeeding duration among primiparous women in Finland.
Detailed description
The investigators hypothesize that the use of mobile intervention for breastfeeding counseling to primiparous women improve the exclusive breastfeeding rates, breastfeeding attitudes, breastfeeding confidence and the satisfaction of breastfeeding counselling. These outcomes are assumed to be higher in the intervention group than in the control group.
Study design
- Primary purpose
- Other
- 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 primiparous mothers. Participants are randomized to two groups, a intervention and a control group. Participants receive standard usual care of breastfeeding counselling in both groups. In addition, the intervention group members will use mobile intervention of breastfeeding counseling.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Mobile intervention of breastfeeding counselingIn addition to standard usual care of breastfeeding counseling, the intervention group will have an opportunity to access the mobile application breastfeeding counseling from weeks 18 of pregnancy, continuing for up to 6 months after childbirth. |
| Control group | No intervention | –The control group receives the standard usual care of breastfeeding counseling in maternity care and in hospital from weeks 18 of pregnancy, continuing for up to 6 months after childbirth. The standard usual care of breastfeeding follows the 10 steps of the Baby Friendly Hospital Initiative programme and Finnish Institute for Health and Welfare recommendation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- primiparous women
- 18 years or older
- finnish language
- singleton foetus
- have an intention to breastfeed
Key exclusion criteria (2 listed)
- multiple pregnancy
- risk pregnancy, or other disease to be monitored
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 |
|---|---|---|
| Mobile intervention of breastfeeding counselingThe mobile intervention of breastfeeding counseling includes an evidence-based information of breastfeeding, which is based on Ten steps of breastfeeding of Baby Friendly Hospital Initiative (BFHI) and Finnish Institute for Health and Welfare recommendation. The links provide more information and videos related to breastfeeding topic. The mobile intervention of breastfeeding counseling allows the client to write comments or notes that can be used in counseling at maternity clinic or hospital. The mobile intervention of breastfeeding counseling also provides an e-mail to non-urgent questions related to breastfeeding. Questions will be answered within 3 or 4 days by a lactation consultant (IBCLC). | Device | Intervention group |
Primary outcome
Exclusive breastfeeding relative rate at 1 months of age
Time frame: 1 month after childbirth
Proportion of infants exclusive breastfeeding at 1 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
Exclusive breastfeeding relative rate at 4 months of age
Time frame: 4 moths after childbirth
Proportion of infants exclusive breastfeeding at 4 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
Exclusive breastfeeding relative rate at 6 months of age
Time frame: 6 months after childbirth
Proportion of infants exclusive breastfeeding at 6 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.
5 secondary outcomes
The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancy
Time frame: Measurements are made in 18 and 34 weeks of gestation
Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)
Time frame: Measurements are made in 1 and 4 months after childbirth
Satisfaction of breastfeeding guidance
Time frame: Measurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.
Use of infants additional milk at hospital after childbirth
Time frame: The researcher retrieves the data from the patient record after 6 months of childbirth.
Infants exclusive breastfeeding rate (relative share / portion)
Time frame: The researcher retrieves the data from the patient record after 6 months of childbirth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile intervention of breastfeeding counseling in people with Breast Feeding, Exclusive, run by University of Oulu at 1 site in Finland.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pirkko Nikula (+358 405145342, pirkko.nikula@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding relative rate at 1 months of age (time frame: 1 month after childbirth). The study lists 3 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 25 May 2022.