Breastfeeding - a Good Start Together

February 16, 2023 updated by: Sarah Fredsted Villadsen, University of Copenhagen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

3339

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sarah F Villadsen, PhD
  • Phone Number: +4535327997
  • Email: sfv@sund.ku.dk

Study Contact Backup

  • Name: Ingrid SM Nilsson, PhD
  • Phone Number: +4522672006
  • Email: in@sundkom.dk

Study Locations

  • Denmark
      • Aabenraa, Denmark, 6200
        • Recruiting
        • Aabenraa Kommune
        • Contact:
      • Aabybro, Denmark, 9440
      • Aars, Denmark, 9600
      • Assens, Denmark, 5610
      • Billund, Denmark, 7190
        • Recruiting
        • Billund Kommune
        • Contact:
      • Esbjerg, Denmark, 6700
        • Recruiting
        • Esbjerg Kommune
        • Contact:
      • Fredericia, Denmark, 7000
      • Frederikshavn, Denmark, 9900
      • Haderslev, Denmark, 6100
      • Hobro, Denmark, 9500
      • Kolding, Denmark, 6000
      • Middelfart, Denmark, 5500
      • Nykøbing Mors, Denmark, 7900
        • Recruiting
        • Morsø Kommune
        • Contact:
      • Odense, Denmark, 5000
        • Recruiting
        • Odense Kommune
        • Contact:
      • Ringe, Denmark, 5750
        • Recruiting
        • Faaborg-Midtfyn Kommune
        • Contact:
      • Svendborg, Denmark, 5700
      • Sønderborg, Denmark, 6400
      • Thisted, Denmark, 7700
        • Recruiting
        • Thisted Kommune
        • Contact:
      • Tønder, Denmark, 6270
      • Varde, Denmark, 6800
        • Recruiting
        • Varde Kommune
        • Contact:
      • Vejen, Denmark, 6600
        • Recruiting
        • Vejen Kommune
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1a. Families discharged <72 hours post partum (from 26 April 2022 - 17 January 2023)

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:

  • Insufficient skills in Danish or English language to be able to answer questionnaires and understand interventions conveyed in Danish or English
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: Control
Health visitors in the control municipalities will give breastfeeding support according to standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal self-report of breastfeeding status (full vs not full)
Time Frame: Four months post partum
Self-reported breastfeeding measured in questionnaires by the mothers and health visitors' record of breastfeeding status. Full breastfeeding is conceptualized as exclusive breastmilk-feeding after discharge from the hospital. In Denmark, the concept allows for a supplement to mother's milk of water and the like and / or a maximum of one meal with infant formula per week.
Four months post partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant thriving - jaundice
Time Frame: From birth to one months post partum
Change in readmissions of children dur to jaundice is used as an indicator of infant morbidity related to nutritional problems. Measured by self-report in questionnaires and obtained from Danish registers of hospital admissions.
From birth to one months post partum
Infant thriving - weight loss
Time Frame: From birth to one months post partum
Change in readmissions of children due to weight loss is used as an indicator of infant morbidity related to nutritional problems. Measured by self-report in questionnaires and obtained from Danish registers of hospital admissions.
From birth to one months post partum
Infant thriving - dehydration
Time Frame: From birth to one months post partum
Change in readmissions of children due dehydration is used as an indicator of infant morbidity related to nutritional problems. Measured by self-report in questionnaires and obtained from Danish registers of hospital admissions.
From birth to one months post partum
Breastfeeding problems
Time Frame: One week and one month post partum
Change in frequency of pain during breastfeeding, sores or cracks on nipples, problems with latching on, the experience of having too little milk, the experience of having too much milk, the experience that the infant wants to feed very frequently, the experience of long duration of each breastfeeding, problems with low infant weight gain, breast tension, mastitis. This will be assessed through maternal self report in questionnaires.
One week and one month post partum
Trust in visiting nurse
Time Frame: One month and four months
Maternal self reported feeling of being seen, respected and heard
One month and four months
Breastfeeding self-efficacy
Time Frame: One month
Maternal and paternal self report in survey
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Danish Committee for Health Education
Nordea-fonden
Det Obelske Familiefond
21 municipalities in Denmark

Investigators

  • Principal Investigator: Ingrid SM Nilsson, PhD, The Danish Committee of Health Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BREASTFEEDING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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