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

NCT ID: NCT05191303

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2023-09-01

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.

Conditions

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Breast Feeding, Exclusive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Mobile intervention of breastfeeding counseling

Intervention Type 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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Pirkko Nikula

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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City of Oulu Maternity Clinic

Oulu, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Pirkko Nikula

Role: CONTACT

+358 405145342

Facility Contacts

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Pirkko Nikula

Role: primary

+358 405145342

Tarja Pölkki

Role: backup

+358 504280772

Other Identifiers

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1954032

Identifier Type: -

Identifier Source: org_study_id

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