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

Developing Mobile Intervention of the Breast Feeding Counseling and Evaluating Its Effectiveness in Primiparous Mothers

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05191303
Enrollment
228
Registered
2022-01-13
Start date
2022-04-04
Completion date
2023-09-01
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Exclusive

Keywords

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

Brief 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.

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.

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).

Sponsors

Oulu University Hospital
CollaboratorOTHER
University of Oulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Statistician, who is not involved in the study has done block-randomization with variable block-sizes (2,4,6) by StatsDirect program for two groups; an intervention and control group. Maternity care staff asks informed consent and then performs the randomization of primiparous women to the intervention or control group.

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

* multiple pregnancy * risk pregnancy, or other disease to be monitored

Design outcomes

Primary

MeasureTime frameDescription
Exclusive breastfeeding relative rate at 1 months of age1 month after childbirthProportion 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 age4 moths after childbirthProportion 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 age6 months after childbirthProportion of infants exclusive breastfeeding at 6 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.

Secondary

MeasureTime frameDescription
Use of infants additional milk at hospital after childbirthThe researcher retrieves the data from the patient record after 6 months of childbirth.Use of infants additional milk at hospital after childbirth and only medical supplementary milk accepted
The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancyMeasurements are made in 18 and 34 weeks of gestationIIFAS 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.
Infants exclusive breastfeeding rate (relative share / portion)The researcher retrieves the data from the patient record after 6 months of childbirth.Infants exclusive breastfeeding rate (relative share / portion) when leaving the hospital. Only medical supplementary milk accepted
Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)Measurements are made in 1 and 4 months after childbirthBreastfeeding 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.
Satisfaction of breastfeeding guidanceMeasurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.Satisfaction of breastfeeding guidance measured with Visual Analogue Scale (VAS) (numeric 0 to 10)

Countries

Finland

Contacts

Primary ContactPirkko Nikula
pirkko.nikula@oulu.fi+358 405145342

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026