Early Digi-physical Support During Breastfeeding Initiation

February 19, 2024 updated by: Marina Taloyan, Region Stockholm

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care with physical visits
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.
Active Comparator: Digi-physical breastfeeding counceling

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
  • 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
Other Names:
  • breastfeeding counceling via chatt function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From birth until child is one year old

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of depression symptoms
Time Frame: 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.
From birth until child is one year old

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' self-efficacy breastfeeding their child
Time Frame: From birth until child is one year old
Compare how parents' self-efficacy breastfeeding their child is improved
From birth until child is one year old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Marina Taloyan, Associate Prof., Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BREASTFEEDING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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