Early Digi-physical Support During Breastfeeding Initiation

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044636
• Other study ID #: BREASTFEEDING
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Region Stockholm
• Contact: Marina Taloyan, Associate Prof.
• Phone: 0046737464551
• Email: marina.taloyan[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding Duration
• Depression
• Self Efficacy

Intervention

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

Locations

Country	Name	City	State
Sweden	Region Stockholm/Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parents' self-efficacy breastfeeding their child	Compare how parents' self-efficacy breastfeeding their child is improved	From birth until child is one year old
Primary	Exclusive breastfeeding at 6 months and duration of breastfeeding	Compare the prevalence of exclusive breastfeeding until 6 months and duration of breastfeeding up to one year between the intervention and the control group	From birth until child is one year old
Secondary	Prevalence of depression symptoms	Compare prevalence of depression symptoms between intervention and control group 6-8 weeks after births and 6 plus 12 months after birth.	From birth until child is one year old