Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial.

BACKGROUND: Breastmilk is the ideal nutrition for infants, and breastfeeding protects infants and mothers from a range of adverse health outcomes. In Denmark, most mothers initiate breastfeeding but many cease within the first months resulting in just 14% reaching the World Health Organization recommendation of six months of exclusive breastfeeding. Furthermore, the low breastfeeding proportion at six months is characterised by a marked social inequality. A previous intervention tested in a hospital setting succeeded in increasing the proportion of mothers breastfeeding exclusively at six months. However, most breastfeeding support is provided within the Danish municipality-based health visiting programme. Therefore, the intervention was adapted to fit the health visiting programme and implemented in 21 Danish municipalities. This article reports the study protocol, which will be used to evaluate the adapted intervention. METHODS: The intervention is tested in a cluster-randomised trial at the municipal level. A comprehensive evaluation approach is taken. The effectiveness of the intervention will be evaluated using survey and register data. Primary outcomes are the proportion of women who breastfeed exclusively at four months postpartum and duration of exclusive breastfeeding measured as a continuous outcome. A process evaluation will be completed to evaluate the implementation of the intervention; a realist evaluation will provide an understanding of the mechanisms of change characterising the intervention. Finally, a health economic evaluation will assess the cost-effectiveness and cost-utility of this complex intervention. DISCUSSION: This study protocol reports on the design and evaluation of the Breastfeeding Trial - a cluster-randomised trial implemented within the Danish Municipal Health Visiting Programme from April 2022 to October 2023. The purpose of the programme is to streamline breastfeeding support provided across healthcare sectors. The evaluation approach is comprehensive using a multitude of data to analyse the effect of the intervention and inform future efforts to improve breastfeeding for all. TRIAL REGISTRATION: Prospectively registered with Clinical Trials NCT05311631 https://clinicaltrials.gov/ct2/show/NCT05311631.

Reminder design and childhood vaccination coverage.

A major policy concern across public vaccination programs is non-compliance. Exploiting Danish population data and three national reforms in regression discontinuity designs, we document the effects of reminders for childhood vaccination coverage. Retrospective reminders are primarily effective for families with small children and when sent out close to the recommended vaccination age. Digital and postal reminders are equally effective. Prospective reminders increase timely vaccinations in later childhood and help reaching high coverage for new vaccines in increasingly complex vaccination programs. While reminders prompt additional preventive care for focal children, we find no spillovers to other health behaviors or relatives.

Effects on Child Development and Parent-Child Interaction of the FACAM Intervention: A Randomized Controlled Study of an Interdisciplinary Intervention to Support Women in Vulnerable Positions through Pregnancy and Early Motherhood.

Health inequality can have a profound impact on a child's life. Maternal mental health challenges can hinder bonding, leading to impaired functioning and poorer child outcomes. To provide extra support for vulnerable pregnant women, the FACAM intervention offers the services of a health nurse or family therapist from pregnancy until the child starts school. This study examined the effects of FACAM intervention on pregnant women in vulnerable positions and their children until the child turned two years old. We randomly assigned 331 pregnant women to either FACAM intervention or care as usual and assessed them at baseline and when the infant was 3-6, 12-13.5, and 24 months old. The primary outcome was maternal sensitivity measured by Coding Interactive Behavior (CIB). Secondary outcomes included the parent-child relationship, child social-emotional development, child developmental progress, parent-child interaction, and child development. Our findings indicate that care-as-usual children were significantly more involved than FACAM children when the child was 4-6 months old (b = -0.25, [-0.42; -0.08] d = -0.42). However, we suspect this result is due to a biased dropout. We did not find any significant differences in any other outcomes. Therefore, the study suggests that the FACAM intervention is not superior to care as usual regarding child development and parent-child interaction outcomes.