Early Digi-physical Support During Breastfeeding Initiation

NCT06044636 | Recruiting

• 1 other identifier: BREASTFEEDING
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Self Efficacy; Breastfeeding Duration; Depression

Keywords

Breastfeeding; Depression; Primary Healthcare; Digi-physical; Self-Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prevalence of depression symptoms

  From birth until child is one year old

Other Outcomes (1)

• Parents' self-efficacy breastfeeding their child

  From birth until child is one year old

Study Arms (2)

Digi-physical breastfeeding counceling

ACTIVE COMPARATOR

Interventions: Digi-physical breastfeeding counseling * At discharge from the maternity ward: contact with lactation consultant (breastfeeding support and care) via the support hotline with chat as soon as questions or problems arise. The hotline will be available during the whole project period. * After discharge from the maternity ward: pediatric nurse from Child Health Care Unit (CHC) will contact families and make a home visit (physical or digital), giving extended lactation advice and support. Additional home visits if needed. * After discharge until one year after childbirth: the possibility of getting into contact with specialized lactation consultant/nurse at lactation counseling units if needed. Intervention type: Chatt via Application Alltid Öppet owned by Region Stockholm. The intervention group will follow current healthcare routines in the Region Stockholm and will get access to an evidence-based information package about breastfeeding from pregnancy week 20.

Other: Digi-physical breastfeeding support

Usual care with physical visits

NO INTERVENTION

Title: Usual care with physical visits The control group will follow current healthcare routines in the Region Stockholm and will get access to an evidence-based information package about breastfeeding from pregnancy week 20.

Interventions

Digi-physical breastfeeding support OTHER

* 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

Also known as: breastfeeding counceling via chatt function

Digi-physical breastfeeding counceling

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Region Stockholm/Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Depression

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Behavioral Symptoms

Study Officials

• Marina Taloyan, Associate Prof.

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Taloyan, Associate Prof.

CONTACT

0046737464551; marina.taloyan@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: January 18, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)