Breastfeeding has numerous health benefits for both mothers and children, and the World
Health Organization recommends exclusive breastfeeding for six months. Still, only 12 %
of mothers in Denmark breastfeed exclusively at six months postpartum and breastfeeding
is subject to significant social inequality. Mothers of young age (below 25 years) and
with low educational attainment (not exceeding primary school or vocational) breastfeed
for a shorter duration of time than their counterparts. Thus, this group is in high risk
of early breastfeeding cessation and is hereafter termed 'the high-risk group'.
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.