NCT05311631

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,010

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

21 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2022Jun 2028

First Submitted

Initial submission to the registry

March 11, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2023

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Expected
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

March 11, 2022

Last Update Submit

February 4, 2026

Conditions

BreastfeedingBreastfeeding, Exclusive

Keywords

Social inequalityBreastfeeding self-efficacyBreastfeeding supportComplex interventionsPublic health

Outcome Measures

Primary Outcomes (1)

  • Maternal self-report of breastfeeding status (full vs not full)

    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 Outcomes (9)

  • Maternal self-report of breastfeeding status (full vs not full)

    Six months post partum

  • Infant thriving - jaundice

    From birth to one months post partum

  • Infant thriving - weight loss

    From birth to one months post partum

  • Infant thriving - dehydration

    From birth to one months post partum

  • Breastfeeding problems

    One week and one month post partum

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Health visitors in the control municipalities will give breastfeeding support according to standard care.

Interventions

Breastfeeding supportBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a. Families discharged \<72 hours post partum (from 26 April 2022 - 17 January 2023)
  • b. Families discharged \< 7 days post partum (from 18 January 2023 onwards due to lower than expected recruitment rate)
  • \. Families with intention of breastfeeding

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Aabenraa Kommune

Aabenraa, 6200, Denmark

Location

Jammerbugt Kommune

Aabybro, 9440, Denmark

Location

Vesthimmerland Kommune

Aars, 9600, Denmark

Location

Assens Kommune

Assens, 5610, Denmark

Location

Billund Kommune

Billund, 7190, Denmark

Location

Esbjerg Kommune

Esbjerg, 6700, Denmark

Location

Fredericia Kommune

Fredericia, 7000, Denmark

Location

Frederikshavn Kommune

Frederikshavn, 9900, Denmark

Location

Haderslev Kommune

Haderslev, 6100, Denmark

Location

Mariagerfjord Kommune

Hobro, 9500, Denmark

Location

Kolding Kommune

Kolding, 6000, Denmark

Location

Middelfart Kommune

Middelfart, 5500, Denmark

Location

Morsø Kommune

Nykøbing Mors, 7900, Denmark

Location

Odense Kommune

Odense, 5000, Denmark

Location

Faaborg-Midtfyn Kommune

Ringe, 5750, Denmark

Location

Svendborg Kommune

Svendborg, 5700, Denmark

Location

Sønderborg Kommune

Sønderborg, 6400, Denmark

Location

Thisted Kommune

Thisted, 7700, Denmark

Location

Tønder Kommune

Tønder, 6270, Denmark

Location

Varde Kommune

Varde, 6800, Denmark

Location

Vejen Kommune

Vejen Municipality, 6600, Denmark

Location

Related Publications (5)

  • Jacobsen MH, Gadeberg AK, Rossau HK, Nilsson IMS, Villadsen SF. Understanding fathers' responses to breastfeeding as a "shared parental task": a realist evaluation of a Danish breastfeeding support intervention. Arch Public Health. 2025 Nov 27;83(1):299. doi: 10.1186/s13690-025-01790-2.

    PMID: 41299756DERIVED

  • 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.

    PMID: 39380053DERIVED

  • 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.

    PMID: 39358759DERIVED

  • 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.

    PMID: 38905959DERIVED

  • 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.

    PMID: 36890478DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Ingrid SM Nilsson, PhD

    The Danish Committee of Health Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Clusters (municipalities) are randomized to either intervention or control (standard care). Intervention coverage 6000 infants and their families in intervention municipalities. Primary trial outcome is assessed using survey data where 3339 families from the intervention and control arm will be enrolled according to the power calculation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 11, 2022

First Posted

April 5, 2022

Study Start

April 26, 2022

Primary Completion

November 6, 2023

Study Completion (Estimated)

June 30, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(21)