Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05311631 |
| Other study ID # |
Breastfeeding |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2022 |
| Est. completion date |
November 6, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Copenhagen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Breastfeeding - a Good Start Together intervention study aims to increase the proportion
of women who breastfeed for four and six months, and proportionately more in a group of women
who are in risk of early breastfeeding cessation; and thus reduce social inequality of mother
and infant health.
Description:
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.
