Early Digi-physical Support During Breastfeeding Initiation

Study Overview
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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.

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.

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

Conditions
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Breastfeeding, Self Efficacy, Breastfeeding Duration, Depression

Intervention / Treatment
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* Other: Digi-physical breastfeeding support


Participation Criteria
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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 Exclusion Criteria: Parents without adequate Swedish language skills Parents resident outside the Stockholm Region

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Digi-physical breastfeeding counceling<br>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: possibility of getting contact with specialized lactation consultant/nurse at lactation counseling units if needed. 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<br>* 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<br>* Other names: breastfeeding counceling via chatt function;|
| No Intervention: Usual care with physical visits<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Depression, Primary Healthcare, Digi-physical, Self-Efficacy