BreastfeedingNCT06044636
Early Digi-physical Support During Breastfeeding Initiation
A study testing Digi-physical breastfeeding support in people with Breastfeeding and Self Efficacy, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Self Efficacy, Breastfeeding Duration
- What is being tested?
- Digi-physical breastfeeding support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSweden
- Study dates
- 18 Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Parents without adequate Swedish language skills
- Parents resident outside the Stockholm Region
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Region Stockholm/Karolinska Institutet
Stockholm
Marina Taloyan, Assoc. Prof., 0046737464551, marina.taloyan@regionstockholm.se
About this study
Official title: Early Digi-physical Support During Breastfeeding Initiation Linked to Continued Support at the Breastfeeding Clinic
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.
Read the 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.
- Conditions
- Breastfeeding, Self Efficacy, Breastfeeding Duration, Depression
- Being tested
- Digi-physical breastfeeding support
- Keywords
- Breastfeeding, Depression, Primary Healthcare, Digi-physical, Self-Efficacy
- Medical subject headings
- Breast Feeding, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digi-physical breastfeeding supportOther
Also called breastfeeding counceling via chatt function
- 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
| Study group | Role | What they receive |
|---|---|---|
| Digi-physical breastfeeding counceling | Active comparator | 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. Receives: Other: Digi-physical breastfeeding support |
| Usual care with physical visits | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From birth until child is one year old
Secondary outcomes (1)
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.
Measured: From birth until child is one year old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Marina Taloyan, Region Stockholm
- Investigators
- Marina Taloyan, Associate Prof., Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044636
- Sponsor's protocol ID
- BREASTFEEDING
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Digi-physical Support During Breastfeeding Initiation Linked to Continued Support at the Breastfeeding Clinic
- ClinicalTrials.gov ID
- NCT06044636
- Acronym / sponsor ID
- BREASTFEEDING
- Conditions
- Breastfeeding, Self Efficacy, Breastfeeding Duration, Depression
- Keywords
- Breastfeeding, Depression, Primary Healthcare, Digi-physical, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digi-physical breastfeeding counceling | Active comparator | Other: Digi-physical breastfeeding supportInterventions: 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. |
| Usual care with physical visits | No intervention | –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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Parents without adequate Swedish language skills
- Parents resident outside the Stockholm Region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digi-physical breastfeeding supportAlso: breastfeeding counceling via chatt function* 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 | Digi-physical breastfeeding counceling |
Primary outcome
Exclusive breastfeeding at 6 months and duration of breastfeeding
Time frame: 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
1 secondary outcome
Prevalence of depression symptoms
Time frame: From birth until child is one year old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Taloyan, Associate Prof. principal investigator
Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digi-physical breastfeeding support in people with Breastfeeding and Self Efficacy, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Taloyan, Associate Prof. (0046737464551, marina.taloyan@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding at 6 months and duration of breastfeeding (time frame: From birth until child is one year old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.