Get the Benefits From the Start. Improving Breastfeeding
NCT ID: NCT05871853
Last Updated: 2023-06-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
1600 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-05-25
Study Completion Date
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Breastfeeding is beneficial for the physical and mental health of mothers and infants alike.
Most new mothers in Denmark intend to breastfeed, however, a substantial proportion do not succeed to breastfeed as intended.
In Region Zealand, few women breastfeed than in the rest of Denmark in which may be related to a higher proportion of women being overweight, having socio-economic constraints and a low educational level, all associated with breastfeeding difficulties. There is limited knowledge on how to deliver a tailored support aimed at families at high risk of breastfeeding difficulties in a high-income country.
We plan to conduct a study aiming to strengthen breastfeeding support to families at risk of breastfeeding difficulties, delivering at Slagelse Hospital, across healthcare sectors, including obstetric and neonatal departments, primary care and civil society.
The study aims to develop, implement, and evaluate a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand, Denmark.
Potentially, results can help reducing inequality in health thus more families achieve exclusive breastfeeding and gain health benefits from breastfeeding
Most new mothers in Denmark intend to breastfeed, however, a substantial proportion do not succeed to breastfeed as intended.
In Region Zealand, few women breastfeed than in the rest of Denmark in which may be related to a higher proportion of women being overweight, having socio-economic constraints and a low educational level, all associated with breastfeeding difficulties. There is limited knowledge on how to deliver a tailored support aimed at families at high risk of breastfeeding difficulties in a high-income country.
We plan to conduct a study aiming to strengthen breastfeeding support to families at risk of breastfeeding difficulties, delivering at Slagelse Hospital, across healthcare sectors, including obstetric and neonatal departments, primary care and civil society.
The study aims to develop, implement, and evaluate a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand, Denmark.
Potentially, results can help reducing inequality in health thus more families achieve exclusive breastfeeding and gain health benefits from breastfeeding
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Breastfeeding - a Good Start Together
NCT05311631
Breastfeeding
Breastfeeding, Exclusive
ACTIVE_NOT_RECRUITING
NA
Evaluation of Breastfeeding Support After Short Time Hospitalization
NCT01620723
Breastfeeding
COMPLETED
NA
Early Breastfeeding Cessation - is It Possible to Prevent?
NCT00145834
Breastfeeding
Practice
Maternal Behaviour
+1 more
COMPLETED
PHASE1
Breastfeeding Education Support Tool for Baby
NCT03533725
Breastfeeding
COMPLETED
NA
Risk Factors of Breastfeeding Study
NCT00195962
Healthy
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background. Breastfeeding is a tailored nutrition for newborn infants in their first years. Breastfeeding has short and long-term positive health effects on both mothers and infants.
For infants, breastfeeding has a protective effect against sudden infant death, respiratory, gastrointestinal and ear infections, obesity, diabetes and childhood leukemia. Breastfeeding also benefits the infant's cognitive development. Studies have found that breastfeeding positively affects the infant's cognitive abilities and IQ. For premature infants, mothers' own milk also protects against the potentially life-threatening disease necrotizing enterocolitis as well as reducing the risk of retinopathy of prematurity for very preterm infants.
For mothers, breastfeeding carries a reduced risk of type 2 diabetes, breast- and ovarian cancer and reduce the risk of cardiovascular disease and benefits the mothers because it may reduce depression and stress. Furthermore, breastfeeding may increase a secure mother-infant attachment, and improve the mother's emotional response to the infant, proportionally with the duration of breastfeeding.
The World Health Organization(WHO) recommends exclusive breastfeeding for six months and partially for two years or longer and has set a goal of optimizing breastfeeding in 2025. Danish Health Authorities also recommend exclusive breastfeeding for six months and partially for one year or longer.
Internationally breastfeeding rates and duration has declined and Denmark is no exception. Breastfeeding has a social barrier both in the early phase of initiation and in the first months, in low-income as well as in high-income countries. We know that breastfeeding follows a pattern of inequalities, and women with less education and low socio-economic status are less likely to exclusively breastfeed.
Declining rates of breastfeeding are a growing problem, as exclusive breastfeeding has decreased over the last decade in all Danish regions. Region Zealand is one of the regions with the lowest rate of exclusive breastfeeding when the infant is four months old compared to the rest of Denmark. Even though Denmark has a relatively well developed health care system with (at least formal) equal access to health services, inequality in health is growing, especially in Region Zealand.
Certain factors are known to be associated with difficulties in initiating and sustaining breastfeeding. These include maternal overweight, gestational diabetes, delivery by cesarean section, admission of the infant to Neonatal Intensive Care Unit (NICU) due to being small, premature or sick, as well as breastfeeding problems with a previous child, previous operations on the breast, social and economic constraints and psychosocial problems for the mother.
In Denmark, we have guidelines for breastfeeding counselling after uncomplicated birth. We know that early interventions will change the trajectory of non-infectious diseases. We lack, however, knowledge on how to offer differentiated care for breastfeeding mother and infant dyads with risk factors for complicated breastfeeding, including how we can improve collaboration with healthcare visitors in the municipalities to make the best transition from hospital to home. We do not have differentiated programs so we help the families who need help the most.
Purpose and hypotheses. This study aims to develop, implement and assess the effect of cross-sectoral cooperation aiming to support breastfeeding in families who give birth at Slagelse Hospital and who are at high risk of complicated breastfeeding. We intend to set up a new service where we provide families at high risk of complicated breastfeeding, with differentiated, practical counselling based on the family's needs, and evidence-based knowledge.
Our hypothesis is that an early differentiated and locally adapted intervention will increase the initiation rate and duration of breastfeeding among women delivering at Slagelse Hospital.
The study is an independent part of an initiative at Slagelse Hospital, Region Zealand, aiming to reduce inequality in health among children.
The study design is a clinical prospective observational cohort study: The development, implementation, and evaluation of a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand, Denmark.
Aim. To develop, implement and evaluate a locally adapted and differentiated breastfeeding-counselling model, focusing especially on families at risk of experiencing breastfeeding difficulties, and therefore most likely to benefit from health-promoting efforts like breastfeeding support.
Research question. Will the implementation of a locally adapted intervention aimed at supporting families at high risk of complicated breastfeeding outcomes lead to an increase in the proportion of exclusively breastfed children at four months of age when compared to a cohort born before the intervention?
Study design. In a prospective, observational design, we will follow families delivering during eight months following the implementation of the intervention and compare to a control group of families delivering during eight months before the intervention.
Intervention. The intervention is a complex process and we will therefore use a theoretical framework for complex interventions developed by the Medical Research Council, as a sustainable effort for breastfeeding, requires collaboration across sectors, the involvement of various health professions and the involvement of users and stakeholders from the local community.
The exact design of the intervention will therefore be determined according to the results of this process.
However, the intervention is likely to include components described in the WHO's Baby Friendly Hospital Initiative (BFHI) and neonatal BFHI:
We plan to stratify the intervention by identifying women at risk either at prenatal consultations during pregnancy, or at birth:
1. Women with low risk factors will be given the care described in Danish National Guideline for initiation of breastfeeding after an uncomplicated birth
2. Women with a moderate risk will be offered a seven day program with easy contact to the maternity ward as described by the Danish Health Authorities in the early postpartum period
3. Women with high risk will be offered a tailored intervention with an easy access to qualified breastfeeding counselling. This service will be planned in co-creation with peer support groups from the organization "Forældre og Fødsel", midwives and nurses at the Slagelse hospital maternity ward, nurses at the Slagelse hospital neonatal ward, and health visitors from three municipalities in Region Zealand.
Although the intervention has a specific focus on those in the highest risk, it may also improve the care given to families at lower risk of breastfeeding complication by raising general awareness and improving the knowledge among health care workers.
Materials and methods. We will perform a prospective observational cohort study, following families giving birth during the eight months before the intervention (pre-cohort), compared to a cohort of families giving birth during eight months after the intervention is implemented (post-cohort). Children born during a pilot phase of 4 months between the pre-cohort and the complete implementation of the intervention will not be included in the data collection.
Participants. Primarily the intervention aims at families in a target group of families at high risk of complicated breastfeeding; however, as the intervention may also include a general change of culture and attitude, as well as a general improved training among health staff, it may potentially benefit all families. We will therefore collect data from all families delivering at the hospital, including families in the target group, and from low-risk families delivering at the hospital who give consent to participate in the study (collect data).
Data collection. Data will be collected on all consenting families giving birth at Slagelse Hospital in the period of eight months before the intervention, and one year after. Consent to collect and store patient data will be obtained from families at inclusion.
Data on primary and secondary outcomes will be collected through electronic questionnaires after discharge. If the families do not fill out (in) the questionnaires themselves, they will be contacted by telephone.
Power and sample size estimation. It is assumed that 50% of all women currently breastfeed their child for four months based on the Danish Child Database(18). Showing an increase after the intervention to 57% with a power of 80% and alpha of 0.05 requires that we include 796 families in the control and intervention cohort. This is estimated to be achievable as there are approximately 1,800 births annually Slagelse Hospital. This means that in 8 months there are approximately 1,200 women giving birth, of which 80% are expected to give consent for data collection, corresponding to 960 families.
For infants, breastfeeding has a protective effect against sudden infant death, respiratory, gastrointestinal and ear infections, obesity, diabetes and childhood leukemia. Breastfeeding also benefits the infant's cognitive development. Studies have found that breastfeeding positively affects the infant's cognitive abilities and IQ. For premature infants, mothers' own milk also protects against the potentially life-threatening disease necrotizing enterocolitis as well as reducing the risk of retinopathy of prematurity for very preterm infants.
For mothers, breastfeeding carries a reduced risk of type 2 diabetes, breast- and ovarian cancer and reduce the risk of cardiovascular disease and benefits the mothers because it may reduce depression and stress. Furthermore, breastfeeding may increase a secure mother-infant attachment, and improve the mother's emotional response to the infant, proportionally with the duration of breastfeeding.
The World Health Organization(WHO) recommends exclusive breastfeeding for six months and partially for two years or longer and has set a goal of optimizing breastfeeding in 2025. Danish Health Authorities also recommend exclusive breastfeeding for six months and partially for one year or longer.
Internationally breastfeeding rates and duration has declined and Denmark is no exception. Breastfeeding has a social barrier both in the early phase of initiation and in the first months, in low-income as well as in high-income countries. We know that breastfeeding follows a pattern of inequalities, and women with less education and low socio-economic status are less likely to exclusively breastfeed.
Declining rates of breastfeeding are a growing problem, as exclusive breastfeeding has decreased over the last decade in all Danish regions. Region Zealand is one of the regions with the lowest rate of exclusive breastfeeding when the infant is four months old compared to the rest of Denmark. Even though Denmark has a relatively well developed health care system with (at least formal) equal access to health services, inequality in health is growing, especially in Region Zealand.
Certain factors are known to be associated with difficulties in initiating and sustaining breastfeeding. These include maternal overweight, gestational diabetes, delivery by cesarean section, admission of the infant to Neonatal Intensive Care Unit (NICU) due to being small, premature or sick, as well as breastfeeding problems with a previous child, previous operations on the breast, social and economic constraints and psychosocial problems for the mother.
In Denmark, we have guidelines for breastfeeding counselling after uncomplicated birth. We know that early interventions will change the trajectory of non-infectious diseases. We lack, however, knowledge on how to offer differentiated care for breastfeeding mother and infant dyads with risk factors for complicated breastfeeding, including how we can improve collaboration with healthcare visitors in the municipalities to make the best transition from hospital to home. We do not have differentiated programs so we help the families who need help the most.
Purpose and hypotheses. This study aims to develop, implement and assess the effect of cross-sectoral cooperation aiming to support breastfeeding in families who give birth at Slagelse Hospital and who are at high risk of complicated breastfeeding. We intend to set up a new service where we provide families at high risk of complicated breastfeeding, with differentiated, practical counselling based on the family's needs, and evidence-based knowledge.
Our hypothesis is that an early differentiated and locally adapted intervention will increase the initiation rate and duration of breastfeeding among women delivering at Slagelse Hospital.
The study is an independent part of an initiative at Slagelse Hospital, Region Zealand, aiming to reduce inequality in health among children.
The study design is a clinical prospective observational cohort study: The development, implementation, and evaluation of a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand, Denmark.
Aim. To develop, implement and evaluate a locally adapted and differentiated breastfeeding-counselling model, focusing especially on families at risk of experiencing breastfeeding difficulties, and therefore most likely to benefit from health-promoting efforts like breastfeeding support.
Research question. Will the implementation of a locally adapted intervention aimed at supporting families at high risk of complicated breastfeeding outcomes lead to an increase in the proportion of exclusively breastfed children at four months of age when compared to a cohort born before the intervention?
Study design. In a prospective, observational design, we will follow families delivering during eight months following the implementation of the intervention and compare to a control group of families delivering during eight months before the intervention.
Intervention. The intervention is a complex process and we will therefore use a theoretical framework for complex interventions developed by the Medical Research Council, as a sustainable effort for breastfeeding, requires collaboration across sectors, the involvement of various health professions and the involvement of users and stakeholders from the local community.
The exact design of the intervention will therefore be determined according to the results of this process.
However, the intervention is likely to include components described in the WHO's Baby Friendly Hospital Initiative (BFHI) and neonatal BFHI:
We plan to stratify the intervention by identifying women at risk either at prenatal consultations during pregnancy, or at birth:
1. Women with low risk factors will be given the care described in Danish National Guideline for initiation of breastfeeding after an uncomplicated birth
2. Women with a moderate risk will be offered a seven day program with easy contact to the maternity ward as described by the Danish Health Authorities in the early postpartum period
3. Women with high risk will be offered a tailored intervention with an easy access to qualified breastfeeding counselling. This service will be planned in co-creation with peer support groups from the organization "Forældre og Fødsel", midwives and nurses at the Slagelse hospital maternity ward, nurses at the Slagelse hospital neonatal ward, and health visitors from three municipalities in Region Zealand.
Although the intervention has a specific focus on those in the highest risk, it may also improve the care given to families at lower risk of breastfeeding complication by raising general awareness and improving the knowledge among health care workers.
Materials and methods. We will perform a prospective observational cohort study, following families giving birth during the eight months before the intervention (pre-cohort), compared to a cohort of families giving birth during eight months after the intervention is implemented (post-cohort). Children born during a pilot phase of 4 months between the pre-cohort and the complete implementation of the intervention will not be included in the data collection.
Participants. Primarily the intervention aims at families in a target group of families at high risk of complicated breastfeeding; however, as the intervention may also include a general change of culture and attitude, as well as a general improved training among health staff, it may potentially benefit all families. We will therefore collect data from all families delivering at the hospital, including families in the target group, and from low-risk families delivering at the hospital who give consent to participate in the study (collect data).
Data collection. Data will be collected on all consenting families giving birth at Slagelse Hospital in the period of eight months before the intervention, and one year after. Consent to collect and store patient data will be obtained from families at inclusion.
Data on primary and secondary outcomes will be collected through electronic questionnaires after discharge. If the families do not fill out (in) the questionnaires themselves, they will be contacted by telephone.
Power and sample size estimation. It is assumed that 50% of all women currently breastfeed their child for four months based on the Danish Child Database(18). Showing an increase after the intervention to 57% with a power of 80% and alpha of 0.05 requires that we include 796 families in the control and intervention cohort. This is estimated to be achievable as there are approximately 1,800 births annually Slagelse Hospital. This means that in 8 months there are approximately 1,200 women giving birth, of which 80% are expected to give consent for data collection, corresponding to 960 families.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Breastfeeding
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-implementation group
Women delivering during an eight month period, before the intervention is implemented.
No interventions assigned to this group
Post-implementation group
Women delivering during an eight month period, after the intervention is implemented.
Improved breastfeeding support
Intervention Type
BEHAVIORAL
Cross-sectoral intervention to improve breastfeeding support among women giving birth at Slagelse Hospital, Region Zealand, Denmark
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Improved breastfeeding support
Cross-sectoral intervention to improve breastfeeding support among women giving birth at Slagelse Hospital, Region Zealand, Denmark
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All women giving birth at Slagelse Hospital and their infants during the study period
* Age at 15 years and above
* Age at 15 years and above
Exclusion Criteria
* families with a planned placement of the infant in a fostercare
Minimum Eligible Age
15 Years
Maximum Eligible Age
100 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center for Clinical Research and Prevention
NETWORK
Sponsor Role
collaborator
Region Zealand
OTHER
Sponsor Role
collaborator
Steno Diabetes Center Sjaelland
OTHER_GOV
Sponsor Role
collaborator
Slagelse Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Annemi Lyng Frandsen
Ph. D. Student
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Annemi L Frandsen, MSA
Role: PRINCIPAL_INVESTIGATOR
Børne- og Ungeafdelingen, Slagelse Sygehus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Slagelse Hospital
Slagelse, , Denmark
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Denmark
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REG-094-2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Professional Supporting and Women's Education for Breastfeeding Promotion: Preliminary Study
NCT05271812
UNKNOWN
Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function
NCT00699738
COMPLETED
NA
Minimizing the Risk for Obesity During Infancy by Extensive Advisory Service
NCT01235663
COMPLETED
NA
Evaluation of a Community Health Nurse/Peer Counselor Program to Help Low-Income Women Breastfeed Longer
NCT00608088
COMPLETED
PHASE3
Recombinant Human Prolactin for Lactation Induction
NCT00181623
COMPLETED
PHASE2
Breastfeeding Intervention to Prevent Obesity Among Children
NCT06921382
RECRUITING
NA
The Effect of Lactation Counseling on Breastfeeding Behaviors of Women
NCT05484076
COMPLETED
NA
Project to Promotion of Breastfeeding
NCT03357549
COMPLETED
NA
Professional Breastfeeding Support Intervention
NCT01893736
COMPLETED
NA
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women with Familial Hypercholesterolemia
NCT05367310
RECRUITING
Comparison of Breastfeeding Teaching Intervention
NCT03602729
UNKNOWN
NA
Increase Breastfeeding Duration Among Puerto Rican Mothers
NCT02148237
COMPLETED
NA
Protocol to Support Breastfeeding for Postpartum Women and Mothers of Babies With Congenital Heart Disease
NCT06025864
UNKNOWN
NA
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
NCT06929091
RECRUITING
NA
Effects of Breast Intervention During the Late Pregnancy on the Parturients' Breast Engorgement,Maternal Competence,and Stress
NCT05796284
RECRUITING
NA
Baby-Friendly Community Health Services Evaluation
NCT01025362
COMPLETED
NA
A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women
NCT03744429
COMPLETED
NA
Breastfeeding and Obesity on Offspring Body Composition
NCT02535637
COMPLETED
Kansas University Teen Mothers Project
NCT00222118
COMPLETED
NA
Early Digi-physical Support During Breastfeeding Initiation
NCT06044636
RECRUITING
NA
Evaluation of the Relationship Between Breastfeeding Attitudes and Nutrition Knowledge Levels
NCT06583174
RECRUITING
Reproductive Health Outcomes by Method of Breast Milk Feeding
NCT03568851
COMPLETED
Community Interventions to Improve Breastfeeding
NCT05503069
ACTIVE_NOT_RECRUITING
NA
BEST ABCs: Benefits and Effectiveness of Support Offered Through A Breastfeeding Clinic Study
NCT02043119
COMPLETED
NA
Evaluating a Coparenting Breastfeeding Support Intervention
NCT01536119
COMPLETED
NA