Early Digi-physical Support During Breastfeeding Initiation

Not Applicable

Recruiting

• Conditions: Self Efficacy; Breastfeeding; Breastfeeding Duration; Depression

• Registration Number: NCT06044636
• Lead Sponsor: Region Stockholm

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.

Study Timeline

• Study Start: 2023-01-18
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exclusive breastfeeding at 6 months and duration of breastfeeding	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 Outcome Measures

Name	Time	Method
Prevalence of depression symptoms	From birth until child is one year old	Compare prevalence of depression symptoms between intervention and control group 6-8 weeks after births and 6 plus 12 months after birth.

Trial Locations

Locations (1)

Region Stockholm/Karolinska Institutet; 🇸🇪 Stockholm, Sweden