CClinicalTrials.gg
Status unknownNCT05191303Updated May 25, 2022

Effectiveness of Mobile Intervention for Breast Feeding Counseling (MIBFc) in Primiparous Mothers

An interventional study of Mobile intervention of breastfeeding counseling in Breast Feeding, Exclusive, sponsored by University of Oulu. Status unknown at 1 site in Finland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by University of Oulu · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breast Feeding, Exclusive

Keywords

  • Mobile application
  • Attitude
  • Confidence, Self
  • Counseling
  • Intervention
  • Randomized controlled trial (RCT)
  • Breast Feeding, exclusive
  • Primiparous
03

In context

Lead sponsor

University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • primiparous women
  • 18 years or older
  • finnish language
  • singleton foetus
  • have an intention to breastfeed
  • have a smartphone

Exclusion criteria

Exclusion Criteria:

  • multiple pregnancy
  • risk pregnancy, or other disease to be monitored
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
228 participants (estimated)

Study arms

  • Experimental
    Intervention group

    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.

    Device: Mobile intervention of breastfeeding counseling

  • No intervention
    Control group

    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.

Interventions

  • DeviceMobile intervention of breastfeeding counseling

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month after childbirth

  2. 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.

    Time frame: 4 moths after childbirth

  3. 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.

    Time frame: 6 months after childbirth

Secondary outcomes

  1. 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.

    Time frame: Measurements are made in 18 and 34 weeks of gestation

  2. 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.

    Time frame: Measurements are made in 1 and 4 months after childbirth

  3. Satisfaction of breastfeeding guidance

    Satisfaction of breastfeeding guidance measured with Visual Analogue Scale (VAS) (numeric 0 to 10)

    Time frame: Measurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.

  4. Use of infants additional milk at hospital after childbirth

    Use of infants additional milk at hospital after childbirth and only medical supplementary milk accepted

    Time frame: The researcher retrieves the data from the patient record after 6 months of childbirth.

  5. Infants exclusive breastfeeding rate (relative share / portion)

    Infants exclusive breastfeeding rate (relative share / portion) when leaving the hospital. Only medical supplementary milk accepted

    Time frame: The researcher retrieves the data from the patient record after 6 months of childbirth.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05191303
Lead sponsor
University of Oulu
Collaborators
Oulu University Hospital
Responsible party
Pirkko Nikula (Principal Investigator, University of Oulu) — Principal investigator
First posted
Jan 13, 2022
Start date
Apr 4, 2022
Primary completion
May 31, 2023 (estimated)
Completion
Sep 1, 2023 (estimated)
Last update
May 25, 2022

Study contacts

Pirkko Nikula
Contact
pirkko.nikula@oulu.fi
+358 405145342

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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