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Early Digi-physical Support During Breastfeeding Initiation

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06044636
Enrollment
320
Registered
2023-09-21
Start date
2023-01-18
Completion date
2024-12-31
Last updated
2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Breastfeeding Duration, Depression, Self Efficacy

Keywords

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

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.

Interventions

OTHERDigi-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

Sponsors

Karolinska Institutet
CollaboratorOTHER
Region Stockholm
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Exclusive breastfeeding at 6 months and duration of breastfeedingFrom birth until child is one year oldCompare the prevalence of exclusive breastfeeding until 6 months and duration of breastfeeding up to one year between the intervention and the control group

Secondary

MeasureTime frameDescription
Prevalence of depression symptomsFrom birth until child is one year oldCompare prevalence of depression symptoms between intervention and control group 6-8 weeks after births and 6 plus 12 months after birth.

Other

MeasureTime frameDescription
Parents' self-efficacy breastfeeding their childFrom birth until child is one year oldCompare how parents' self-efficacy breastfeeding their child is improved

Countries

Sweden

Contacts

Primary ContactMarina Taloyan, Associate Prof.
marina.taloyan@regionstockholm.se0046737464551

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026