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

Breast Feeding, Exclusive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191303
• Other study ID #: 1954032
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2022
• Source: University of Oulu
• Contact: Pirkko Nikula
• Phone: +358 405145342
• Email: pirkko.nikula[@]oulu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: September 1, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding, Exclusive

Intervention

Device:
• Mobile 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).

Locations

Country	Name	City	State
Finland	City of Oulu Maternity Clinic	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after childbirth
Primary	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.	4 moths after childbirth
Primary	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.	6 months after childbirth
Secondary	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.	Measurements are made in 18 and 34 weeks of gestation
Secondary	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.	Measurements are made in 1 and 4 months after childbirth
Secondary	Satisfaction of breastfeeding guidance	Satisfaction of breastfeeding guidance measured with Visual Analogue Scale (VAS) (numeric 0 to 10)	Measurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.
Secondary	Use of infants additional milk at hospital after childbirth	Use of infants additional milk at hospital after childbirth and only medical supplementary milk accepted	The researcher retrieves the data from the patient record after 6 months of childbirth.
Secondary	Infants exclusive breastfeeding rate (relative share / portion)	Infants exclusive breastfeeding rate (relative share / portion) when leaving the hospital. Only medical supplementary milk accepted	The researcher retrieves the data from the patient record after 6 months of childbirth.