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Clinical Trials/NCT06044636
NCT06044636
Recruiting
N/A

Early Digi-physical Support During Breastfeeding Initiation Linked to Continued Support at the Breastfeeding Clinic

Region Stockholm1 site in 1 country320 target enrollmentJanuary 18, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Region Stockholm
Enrollment
320
Locations
1
Primary Endpoint
Exclusive breastfeeding at 6 months and duration of breastfeeding
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this Randomized Controlled Trial is to develop and evaluate a digi-physical intervention within primary health care lactation counselling and breastfeeding support to promote exclusive breastfeeding rates during the first 6 months after birth and to prevent depressive symptoms.

The project addresses parents during pregnancy week 20 and 32 and will continue during the infant's first year of life. All participants will get access to an evidence-based information package (theory and practical advises) during pregnancy.

Study aim is to develop and evaluate digital evidence-based information materials and continuous support for both parents in order to increase prevalence of exclusive breastfeeding and duration as well as decreasing the risks of symptoms of post-partum depression.

Detailed Description

The project design is a single-blind randomized controlled trial. The intervention group will receive: * Digital support by chat with a lactation consultant for immediate breastfeeding support two-three weeks after delivery * Extended home visits by pediatric nurses providing extra knowledge and support about lactation * Extra support by health care providers educated in lactation counseling when needed. More specific purposes are: * Compare the prevalence of exclusive breastfeeding until 6 months and duration of breastfeeding up to one year between the intervention and the control group. (Primary outcome) * Compare prevalence of depression symptoms between the intervention and control group. (Secondary outcome) * Strengthening parents' self-efficacy in breastfeeding their child.

Registry
clinicaltrials.gov
Start Date
January 18, 2023
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marina Taloyan

Associate professor

Region Stockholm

Eligibility Criteria

Inclusion Criteria

  • Being pregnant or partner of a person who is pregnant in pregnancy week 20-32
  • All parents with language skills enabling them to fill out questionnaires, participate in interviews and read information.
  • Being resident in Stockholm Region

Exclusion Criteria

  • Parents without adequate Swedish language skills
  • Parents resident outside the Stockholm Region

Outcomes

Primary Outcomes

Exclusive breastfeeding at 6 months and duration of breastfeeding

Time Frame: From birth until child is one year old

Compare the prevalence of exclusive breastfeeding until 6 months and duration of breastfeeding up to one year between the intervention and the control group

Secondary Outcomes

  • Prevalence of depression symptoms(From birth until child is one year old)

Study Sites (1)

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