NCT06044636

Early Digi-physical Support During Breastfeeding Initiation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Region Stockholm · Other Government
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breastfeeding
• Self Efficacy
• Breastfeeding Duration
• Depression

Interventions

Type	Name	Description
OTHER	Digi-physical breastfeeding support	* Breastfeeding support after birth is provided via chat * Extended home visits by a pediatric nurse after discharge from the maternity ward * Extra support from a lactation counselor when needed after discharge until one year after childbirth

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-09-21
• Last updated: 2024-02-21

Locations

1 site across 1 country: Sweden