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

NCT05191303 | Unknown

• 1 other identifier: 1954032
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Feeding, Exclusive

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancy

  Measurements are made in 18 and 34 weeks of gestation

• Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)

  Measurements are made in 1 and 4 months after childbirth

• Satisfaction of breastfeeding guidance

  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

  The researcher retrieves the data from the patient record after 6 months of childbirth.

• Infants exclusive breastfeeding rate (relative share / portion)

  The researcher retrieves the data from the patient record after 6 months of childbirth.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Mobile intervention of breastfeeding counseling DEVICE

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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primiparous women
• years or older
• finnish language
• singleton foetus
• have an intention to breastfeed
• have a smartphone

You may not qualify if:

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

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (1)

City of Oulu Maternity Clinic

Oulu, 90580, Finland

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Behavior

Condition Hierarchy (Ancestors)

Feeding Behavior

Central Study Contacts

Pirkko Nikula

CONTACT

+358 405145342; pirkko.nikula@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 13, 2022
• Study Start: April 4, 2022
• Primary Completion: May 31, 2023
• Study Completion: September 1, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

FI (1)