Early Digi-physical Support During Breastfeeding Initiation - a Single-blind Randomized Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The project design is a single-blind randomized controlled trial.
The intervention group will receive:
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Digital support by chat with a lactation consultant for immediate breastfeeding support two-three weeks after delivery
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Extended home visits by pediatric nurses providing extra knowledge and support about lactation
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Extra support by health care providers educated in lactation counseling when needed.
More specific purposes are:
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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)
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Compare prevalence of depression symptoms between the intervention and control group. (Secondary outcome)
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Strengthening parents' self-efficacy in breastfeeding their child.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention Group Interventions: 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: paediatric 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 to get 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
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:
|
| No Intervention: Control Group 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. |
Outcome Measures
Primary Outcome Measures
- Exclusive breastfeeding at 6 months and duration of breastfeeding [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
Secondary Outcome Measures
- Prevalence of depression symptoms [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.
Other Outcome Measures
- Parents' self-efficacy breastfeeding their child [From birth until child is one year old]
Compare how parents' self-efficacy breastfeeding their child is improved
Eligibility Criteria
Criteria
Inclusion Criteria:
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Being pregnant or partner of a person who is pregnant in pregnancy week 20-32
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All parents with language skills enabling them to fill out questionnaires, participate in interviews and read information.
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Being resident in Stockholm Region
Exclusion Criteria:
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Parents without adequate Swedish language skills
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Parents resident outside the Stockholm Region
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Region Stockholm/Karolinska Institutet | Stockholm | Sweden |
Sponsors and Collaborators
- Region Stockholm
Investigators
- Principal Investigator: Marina Taloyan, Assoc.Prof., Region Stockholm
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BREASTFEEDING