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Bandura A. Self-Efficacy: The Exercise of Control. New York: Worth Publishers; Google Scholar. Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants.

Holmes AV, Mcleod AY, Bunik M. ABM Clinical protocol 5: peripartum breastfeeding management for the healthy mother and infant at term, revision Breastfeed Med. Kent JC, Hepworth AR, Sherriff JL, Cox DB, Mitoulas LR, Hartmann PE.

Longitudinal changes in breastfeeding patterns from 1 to 6 months of lactation. Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, et al. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial.

Int Breastfeed J. Colson SD, Meek JH, Hawdon JM. Optimal positions for the release of primitive neonatal reflexes stimulating breastfeeding. Ogbo F, Akombi B, Ahmed K, Rwabilimbo A, Ogbo A, Uwaibi N, et al. A systematic review. Int J Environ Res Public Health.

Kreuter MW, Strecher VJ, Glassman B. One size does not fit all: The case for tailoring print materials. Anna Behav Med. Article CAS Google Scholar. Accessed: —12— Campbell MJ, Walters SJ.

How to design, analyse and report cluster randomised trials in medicine and health related research: Wiley; Balan TA, Putter H. A tutorial on frailty models. Stat Methods Med Res. Gupta SK.

Intention-to-treat concept: A review. Perspect Clin Res. Pawson R. Nothing as practical as a good theory. Whitley R, Kirmayer LJ. Perceived stigmatisation of young mothers: an exploratory study of psychological and social experience. Link BG, Phelan JC. Conceptualizing stigma.

Ann Rev Sociol. Kronborg H, Væth M. The influence of psychosocial factors on the duration of breastfeeding. Rothman KJ, Greenland S, Lash TL. World Medical Association Declaration of Helsinki. Download references. The research group takes this opportunity to express their gratitude to the health visitors participating in this study and to the municipalities and managements who take part.

We also wish to express our gratitude to the participating families who are contributing with their valuable time during the sensitive postnatal period. The study is funded by Nordea-fonden, Det Obelske Familiefond and the Novo Nordisk Foundation.

The funders had no role in the design of the study and will have no role in the data collection, data analyses, interpretation of the data or the decision to submit any findings for publication.

Section of Social Medicine, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, , Copenhagen, Denmark. The Danish Committee for Health Education, Classensgade 71, 5th floor, , Copenhagen, Denmark.

Section of Biostatistics, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, , Copenhagen, Denmark. The Danish Center for Social Science Research, Herluf Trolles Gade 11, , Copenhagen, Denmark.

Section of Epidemiology, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, , Copenhagen, Denmark. You can also search for this author in PubMed Google Scholar.

IN, KSL and SFV conceived of the study. IN, MBR, KSL and SFV initiated the study design process. IN and MBR developed the intervention, trained the health visitors and headed the implementation.

IN and SFV are grant holders. KSL and CTE provide statistical expertise relating to the trial design and HKR will conduct the primary statistical analysis.

AKG , HKR and JCH participated in developing the realist evaluation, the effectiveness evaluation and process evaluation, and the health economic evaluation, respectively. IN is the PI of the intervention and responsible for the development and implementation of the study.

SFV is the PI of the evaluation and did not participate in the implementation process or the communication with the health visitors. All authors assisted in refining the study protocol and critically reviewed the final manuscript.

The author s read and approved the final manuscript. Correspondence to Henriette Knold Rossau. The study and its evaluation will be conducted in accordance with the Declaration of Helsinki [ 60 ].

In Denmark, health research studies not encompassing medical procedures or collection of biological specimens require no ethical approval. This was confirmed for this study by the Research Ethics Committees of the Capital Region of Denmark R.

Ethical approval was obtained from the Research Ethics Committee at the University of Copenhagen Cno. Upon recruitment, all eligible parents provide written informed consent.

All information sheets and videos are available in Danish and English language. Parents are informed about their ability to withdraw their consent. Confidentiality is ensured by keeping all identifying information about participants and all collected data quantitative and qualitative on a password protected, secure and logged drive owned by the University of Copenhagen, which is accessible only through at least two logins to the UCPHs computers and servers.

Data access will be limited to investigators approved by the principal investigator at the UCPH. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Open Access This article is licensed under a Creative Commons Attribution 4. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material.

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Reprints and permissions. Rossau, H. et al. Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial.

BMC Public Health 23 , Download citation. Received : 20 December Accepted : 09 February Published : 08 March Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative. Skip to main content. Search all BMC articles Search. Download PDF. Abstract Background Breastmilk is the ideal nutrition for infants, and breastfeeding protects infants and mothers from a range of adverse health outcomes.

Methods The intervention is tested in a cluster-randomised trial at the municipal level. 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 to October Background Breast milk is the ideal nutrition for infants.

Objectives The primary objective of the Breastfeeding Trial is to assess the effect of a community-based breastfeeding support programme delivered by health visitors in primary healthcare on the duration of exclusive breastfeeding and social inequality in breastfeeding among women in Denmark.

Methods and analysis Study design The Breastfeeding Trial is a cluster-randomised trial with two arms: an intervention and a control arm. Map of Denmark. Green areas indicate intervention clusters; blue areas, control clusters.

Full size image. Table 1 Description of standard care Full size table. Table 2 Description of the intervention programme Full size table. Programme theory of the Breastfeeding Trial. Overview of the survey study questionnaire distribution.

Table 3 Overview of quantitative data collection, source and timepoints Full size table. Discussion This article outlines a cluster-randomised trial designed to increase breastfeeding duration and reduce social inequality in breastfeeding among Danish women — a population with a high uptake and long duration of breastfeeding compared with high-income countries around the world [ 4 ].

Availability of data and materials Not applicable. Notes The inclusion criteria concerning discharge from the hospital after birth was initially less than 72 h after giving birth. References Victora CG, Bahl R, Barros AJ, França GV, Horton S, Krasevec J, et al.

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Article PubMed PubMed Central Google Scholar Kent JC, Hepworth AR, Sherriff JL, Cox DB, Mitoulas LR, Hartmann PE. Article PubMed Google Scholar Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, et al. Article PubMed PubMed Central Google Scholar Colson SD, Meek JH, Hawdon JM.

Article PubMed Google Scholar Ogbo F, Akombi B, Ahmed K, Rwabilimbo A, Ogbo A, Uwaibi N, et al. Article PubMed PubMed Central Google Scholar Kreuter MW, Strecher VJ, Glassman B. Article CAS Google Scholar The Danish Health Data Authority [Sundhedsdatastyrelsen]. Accessed: —12—02 Campbell MJ, Walters SJ.

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Article Google Scholar Kronborg H, Væth M. Article PubMed Google Scholar Rothman KJ, Greenland S, Lash TL. Article Google Scholar Download references. Acknowledgements The research group takes this opportunity to express their gratitude to the health visitors participating in this study and to the municipalities and managements who take part.

Funding The study is funded by Nordea-fonden, Det Obelske Familiefond and the Novo Nordisk Foundation. View author publications. Ethics declarations Ethics approval and consent to participate The study and its evaluation will be conducted in accordance with the Declaration of Helsinki [ 60 ].

Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. ION Professional.

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