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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Feeding, Exclusive

Intervention / Treatment
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* Device: Mobile intervention of breastfeeding counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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).<br>|
| No Intervention: Control group<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile application, Attitude, Confidence, Self, Counseling, Intervention, Randomized controlled trial (RCT), Breast Feeding, exclusive, Primiparous