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

Not Applicable

• Conditions: Breast Feeding, Exclusive
• Interventions: Device: Mobile intervention of breastfeeding counseling

• Registration Number: NCT05191303
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-13
• Study Start: 2022-04-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25
• Primary Completion: 2023-05-31
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Mobile intervention of breastfeeding counseling	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.

Primary Outcome Measures

Name	Time	Method
Exclusive breastfeeding relative rate at 4 months of age	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 1 months of age	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 6 months of age	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.

Secondary Outcome Measures

Name	Time	Method
Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)	Measurements are made in 1 and 4 months after childbirth	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.
Satisfaction of breastfeeding guidance	Measurements 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)
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
The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancy	Measurements are made in 18 and 34 weeks of gestation	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.
Use of infants additional milk at hospital after childbirth	The 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

Trial Locations

Locations (1)

City of Oulu Maternity Clinic; 🇫🇮 Oulu, Finland