Clinical trial NCT06044636: Early Digi-physical Support During Breastfeeding Initiation
Official title: Early Digi-physical Support During Breastfeeding Initiation Linked to Continued Support at the Breastfeeding Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Self Efficacy
Breastfeeding Duration
Depression
Keywords: Breastfeeding
Depression
Primary Healthcare
Digi-physical
Self-Efficacy
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2023-09-21
Enrollment: 320
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exclusive breastfeeding at 6 months and duration of breastfeeding
timeFrame: From birth until child is one year old
Secondary outcomes:
measure: Prevalence of depression symptoms
timeFrame: From birth until child is one year old
Other outcomes:
measure: Parents' self-efficacy breastfeeding their child
timeFrame: From birth until child is one year old
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm/Karolinska Institutet
Study officials:
affiliation: Region Stockholm
name: Marina Taloyan, Associate Prof.
role: PRINCIPAL_INVESTIGATOR
References: