Early Digi-physical Support During Breastfeeding Initiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Breastfeeding Self Efficacy Breastfeeding Duration Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Digi-physical breastfeeding support

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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breastfeeding counceling via chatt function

Eligibility Criteria

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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