Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
5010 participants
INTERVENTIONAL
2022-04-26
2025-12-31
Brief Summary
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Detailed Description
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The Breastfeeding - a Good Start Together intervention consists of theory based breastfeeding support, supported by printed materials and a web-page providing support and knowledge for families when health visitors are off work, and an intensified intervention aimed at the high-risk group, comprising close follow-up by telephone and an extra home visit. In total, the high-risk group will receive seven telephone calls during week two post partum and 15 weeks post partum, with the highest intensity in the first month (contact once a week), gradually decreasing as the child grows older (contact every second week during the second month, and every third week during the third and fourth month).
Hypothesis: Improving the relationship between health visitors and new families, drawing on tailoring of the communication, which ensures that breastfeeding support matches the needs of the family, will enhance trust and therefore the likelihood of families reaching out to the health nurse when breastfeeding problems occur and thus improving chances of successful breastfeeding in a longer duration of time. Moreover, the theory based breastfeeding support will make the support more easily attainable for families, independent of their sociodemographic background. Improving chances of a successful breastfeeding will improve mother and infant health, the latter especially with regards to lower infant morbidity related to nutrition.
The intervention is a complex intervention, designed as a cluster-randomized trial. Twenty-one municipalities situated in the North Denmark Region and Region of Southern Denmark participate in the study, and according to the number of births among inhabitants these have been randomized to either intervention or control group; 11 intervention municipalities and 10 control municipalities. Basing the randomization on number of births proved to successfully account for other factors, such as rural or urban areas and proportion of high-risk individuals.
The intervention will be implemented from March 2022-December 2023, with data collection commencing April 2022. Health visitors in the intervention municipalities will receive training before delivering the new breastfeeding counselling to the families. The training is expected to reach 225 health visitors in the intervention municipalities and 6000 families of whom 30-40% are in the high-risk group. After the trial period, health visitors in the control municipalities will receive the same training.
The primary outcome measures of the intervention is breastfeeding duration and proxies for infant morbidity related to nutrition. Secondary outcomes are the families' perception of their relationship with the health visitor and parents' action competence and self-efficacy related to breastfeeding.
The primary and secondary outcome measures, are studied in a survey study using electronic questionnaires distributed to mothers recruited through the health-visiting programme at three time-points, and to fathers/partners at one time-point. Further, the effectiveness of the intervention will be analysed using register-data. A difference-in-difference design is applied to measure changes in primary outcomes from before to after the intervention period in both intervention sites and control sites.
The overall target group of the intervention study is all new families accepting the health visiting program with a specific high-risk group of families with mothers of young age or who have low educational attainment. Outcomes of the trial will be analysed for the total population and for the sub-group.
For sample size calculation an estimation of 8 clusters in the intervention arm and 8 clusters in the control arm were used, as this calculation was made prior to successfully recruiting a total of 21 clusters to the trial. The investigators expect a participation of 80% with an attrition of 30%. The ambition is to improve the breastfeeding duration in the intervention clusters to the national level, corresponding to an OR 1.32. With an interclass correlation coefficient of 0.001, a strength of 80% and a 5% significance level can be reached if data are collected from 111 mothers in each cluster, including 52 mothers from the high-risk group in each cluster.
All effectiveness analyses will be using an intention-to-treat approach and will account for the clustering of individuals and potential confounding in a controlled mixed effect regression.
The implementation of the intervention will be analysed in a process evaluation using qualitative and quantitative data. A realist evaluation using qualitative data will explore the mechanisms of change in the intervention, and will highlight what works for whom, under what circumstances.
Further, a health economic evaluation will be performed as a cost-effectiveness analysis where health benefits are measured as changes in the proportion of women breastfeeding at four months post partum, and as a cost-utility analysis where health benefits are measured as gained Quality Adjusted Life-Years (QALYs). Moreover, an analysis of the costs of the intervention related to the costs (and possible savings) in the health system surrounding the intervention sites.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
Improved breastfeeding support provided by health visitors supporting families after discharge from maternity ward at hospital. The intervention is implemented into the existing national health visitor program that is offered free of charge to all. The program is accepted by more than 95% of families.
Breastfeeding support
The core of the intervention is a trustful relation between the health visitor and the families based on principles of needs based communication. Health visitors will enhance parents' action competence based on breastfeeding self-efficacy, focusing on parents' wishes and needs.
The breastfeeding support includes four main messages: joint parenting task, skin-to-skin contact, frequent breastfeeding, and good positioning.
Training of health visitors includes e-learning and a two-day course with physical attendance. Supportive materials are developed including communicative support tools and a web-page providing support and knowledge when the health visitor is off hours.
All families in intervention sites accepting the health visitor program will receive the improved breastfeeding support. Families in the high-risk group are offered an intensified intervention with close follow-up by telephone in planned time-intervals, thus a higher dose of the intervention.
Control
Health visitors in the control municipalities will give breastfeeding support according to standard care.
No interventions assigned to this group
Interventions
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Breastfeeding support
The core of the intervention is a trustful relation between the health visitor and the families based on principles of needs based communication. Health visitors will enhance parents' action competence based on breastfeeding self-efficacy, focusing on parents' wishes and needs.
The breastfeeding support includes four main messages: joint parenting task, skin-to-skin contact, frequent breastfeeding, and good positioning.
Training of health visitors includes e-learning and a two-day course with physical attendance. Supportive materials are developed including communicative support tools and a web-page providing support and knowledge when the health visitor is off hours.
All families in intervention sites accepting the health visitor program will receive the improved breastfeeding support. Families in the high-risk group are offered an intensified intervention with close follow-up by telephone in planned time-intervals, thus a higher dose of the intervention.
Eligibility Criteria
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Inclusion Criteria
1b. Families discharged \< 7 days post partum (from 18 January 2023 onwards due to lower than expected recruitment rate)
2\. Families with intention of breastfeeding
Exclusion Criteria
* Families with mothers with known substance abuse or addiction
* Families expecting more than one child
* Families having delivered preterm, prior to 37 weeks of gestation
* Families with mothers or child having difficulty breastfeeding due to a known morbidity or disablement
15 Years
ALL
Yes
Sponsors
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Danish Committee for Health Education
OTHER
21 municipalities in Denmark
UNKNOWN
Nordea-fonden
UNKNOWN
Det Obelske Familiefond
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Sarah Fredsted Villadsen
Associate Professor
Principal Investigators
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Ingrid SM Nilsson, PhD
Role: PRINCIPAL_INVESTIGATOR
The Danish Committee of Health Education
Locations
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Aabenraa Kommune
Aabenraa, , Denmark
Jammerbugt Kommune
Aabybro, , Denmark
Vesthimmerland Kommune
Aars, , Denmark
Assens Kommune
Assens, , Denmark
Billund Kommune
Billund, , Denmark
Esbjerg Kommune
Esbjerg, , Denmark
Fredericia Kommune
Fredericia, , Denmark
Frederikshavn Kommune
Frederikshavn, , Denmark
Haderslev Kommune
Haderslev, , Denmark
Mariagerfjord Kommune
Hobro, , Denmark
Kolding Kommune
Kolding, , Denmark
Middelfart Kommune
Middelfart, , Denmark
Morsø Kommune
Nykøbing Mors, , Denmark
Odense Kommune
Odense, , Denmark
Faaborg-Midtfyn Kommune
Ringe, , Denmark
Svendborg Kommune
Svendborg, , Denmark
Sønderborg Kommune
Sønderborg, , Denmark
Thisted Kommune
Thisted, , Denmark
Tønder Kommune
Tønder, , Denmark
Varde Kommune
Varde, , Denmark
Vejen Kommune
Vejen Municipality, , Denmark
Countries
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References
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Rossau HK, Gadeberg AK, Strandberg-Larsen K, Nilsson IMS, Villadsen SF. Process evaluation of a breastfeeding support intervention to promote exclusive breastfeeding and reduce social inequity: a mixed-methods study in a cluster-randomised trial. Int J Equity Health. 2024 Oct 8;23(1):204. doi: 10.1186/s12939-024-02295-0.
Nilsson I, Busck-Rasmussen M, Villadsen SF. Development of a complex intervention to strengthen municipality-based breastfeeding support to reduced social inequity in breastfeeding. Arch Public Health. 2024 Oct 2;82(1):174. doi: 10.1186/s13690-024-01401-6.
Rossau HK, Nilsson IMS, Gadeberg AK, Forman JL, Strandberg-Larsen K, Nielsen J, Villadsen SF. Strengthening health visitors' breastfeeding support: Results from a cluster randomised study. Nurse Educ Pract. 2024 Jul;78:104033. doi: 10.1016/j.nepr.2024.104033. Epub 2024 Jun 18.
Rossau HK, Nilsson IMS, Busck-Rasmussen M, Ekstrom CT, Gadeberg AK, Hirani JC, Strandberg-Larsen K, Villadsen SF. Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial. BMC Public Health. 2023 Mar 8;23(1):450. doi: 10.1186/s12889-023-15256-z.
Other Identifiers
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Breastfeeding
Identifier Type: -
Identifier Source: org_study_id