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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Feeding, Exclusive
• Intervention / Treatment: Device: Mobile intervention of breastfeeding counseling

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 Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pirkko Nikula; Phone Number: +358 405145342; Email: pirkko.nikula@oulu.fi

Study Locations

• Finland
  • Oulu, Finland, 90580
    • Recruiting
    • City of Oulu Maternity Clinic
    • Contact: Pirkko Nikula; Phone Number: +358 405145342; Email: pirkko.nikula@oulu.fi
    • Contact: Tarja Pölkki; Phone Number: +358 504280772; Email: tarja.polkki@oulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Counseling; Intervention; Randomized controlled trial (RCT); Attitude; Mobile application; Primiparous; Confidence, Self; Breast Feeding, exclusive
• Other Study ID Numbers: 1954032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No