Clinical trial NCT05191303: Effectiveness of Mobile Intervention for Breast Feeding Counseling (MIBFc) in Primiparous Mothers
Official title: Developing Mobile Intervention of the Breast Feeding Counseling and Evaluating Its Effectiveness in Primiparous Mothers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Feeding, Exclusive
Keywords: Mobile application
Attitude
Confidence, Self
Counseling
Intervention
Randomized controlled trial (RCT)
Breast Feeding, exclusive
Primiparous
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2022-01-13
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exclusive breastfeeding relative rate at 1 months of age
timeFrame: 1 month after childbirth
measure: Exclusive breastfeeding relative rate at 4 months of age
timeFrame: 4 moths after childbirth
measure: Exclusive breastfeeding relative rate at 6 months of age
timeFrame: 6 months after childbirth
Secondary outcomes:
measure: The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancy
timeFrame: Measurements are made in 18 and 34 weeks of gestation
measure: Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)
timeFrame: Measurements are made in 1 and 4 months after childbirth
measure: Satisfaction of breastfeeding guidance
timeFrame: Measurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.
measure: Use of infants additional milk at hospital after childbirth
timeFrame: The researcher retrieves the data from the patient record after 6 months of childbirth.
measure: Infants exclusive breastfeeding rate (relative share / portion)
timeFrame: The researcher retrieves the data from the patient record after 6 months of childbirth.
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: City of Oulu Maternity Clinic
Study officials:
References: