Get the Benefits From the Start. Improving Breastfeeding

NCT05871853 | Recruiting

• 1 other identifier: REG-094-2022
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Breastfeeding is beneficial for the physical and mental health of mothers and infants alike. Most new mothers in Denmark intend to breastfeed, however, a substantial proportion do not succeed to breastfeed as intended. In Region Zealand, few women breastfeed than in the rest of Denmark in which may be related to a higher proportion of women being overweight, having socio-economic constraints and a low educational level, all associated with breastfeeding difficulties. There is limited knowledge on how to deliver a tailored support aimed at families at high risk of breastfeeding difficulties in a high-income country. We plan to conduct a study aiming to strengthen breastfeeding support to families at risk of breastfeeding difficulties, delivering at Slagelse Hospital, across healthcare sectors, including obstetric and neonatal departments, primary care and civil society. The study aims to develop, implement, and evaluate a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand, Denmark. Potentially, results can help reducing inequality in health thus more families achieve exclusive breastfeeding and gain health benefits from breastfeeding

Conditions

Breastfeeding

Keywords

Breastfeeding; Infant; Newborn; Post-natal Care

Outcome Measures

Primary Outcomes (1)

• Rate of mother's self-reporting exclusive breastfeeding

  Mothers who are exclusive breastfeeding in the post-implementation group, compared to the pre-implementation group (n/% of total). Exclusive breastfeeding is defined as exclusive fed at the breast after discharge from hospital. This means, that in addition to breastfeeding, supplements with water and similar and/or a or a maximum of one meal of breastmilk substitute or mothers expressed breastmilk per week.

  4 month postpartum

Secondary Outcomes (8)

• Duration of exclusive breastfeeding

  0-12 month

• Duration of any breastfeeding

  0-12 month

• Rate of exclusive breastfeeding reported by the home-visiting nurse

  4 months

• Any admission of the infant

  0-12 month

• Mothers self-reported well-being

  Third trimester, 14 days, 1 month, 4 month, 6 month after birth

Study Arms (2)

Pre-implementation group

Women delivering during an eight month period, before the intervention is implemented.

Post-implementation group

Women delivering during an eight month period, after the intervention is implemented.

Behavioral: Improved breastfeeding support

Interventions

Improved breastfeeding support BEHAVIORAL

Cross-sectoral intervention to improve breastfeeding support among women giving birth at Slagelse Hospital, Region Zealand, Denmark

Post-implementation group

Eligibility Criteria

• Age: 15 Years - 100 Years
• Gender Eligibility Details: Women giving birth as well as their infants For twins and multiples; only the first born.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women giving birth at Slagelse Hospital and their actual infant

You may qualify if:

• All women giving birth at Slagelse Hospital and their infants during the study period
• Age at 15 years and above

You may not qualify if:

• families with a planned placement of the infant in a fostercare

Sponsors & Collaborators

• Slagelse Hospital: lead
• Center for Clinical Research and Prevention: collaborator
• Region Zealand: collaborator
• Steno Diabetes Center Sjaelland: collaborator

Study Sites (1)

Slagelse Hospital

Slagelse, 4200, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Annemi L Frandsen, MSA

  Børne- og Ungeafdelingen, Slagelse Sygehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemi L Frandsen, MSA

CONTACT

+4522704247; alfr@regionsjaelland.dk

Maren Rytter, Ph.d.

CONTACT

+4527280484; mjry@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph. D. Student

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 23, 2023
• Study Start: May 25, 2023
• Primary Completion: October 15, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

DK (1)