Heslehurst, Nicola http://orcid.org/0000-0001-8656-2319
Rankin, Judith
McParlin, Catherine
Sniehotta, Falko F.
Howel, Denise
Rice, Stephen
McColl, Elaine
Funding for this research was provided by:
Research Trainees Coordinating Centre (PDF-2011-04-034)
Article History
Received: 21 March 2017
Accepted: 24 January 2018
First Online: 9 February 2018
Ethics approval and consent to participate
: This pilot study has received ethical approval from the Proportionate Review Sub-committee of the Yorkshire & The Humber—South Yorkshire Research Ethics Committee, 16/12/2015, ref.: 15/YH/0565. The protocol described here is based on the full protocol submitted to the ethics committee (V1.0, 23/11/2015). Research and development (R&D) approval has also been granted from the four pilot NHS Trusts (clusters). All midwives and pregnant women will need to provide informed consent before participating in this research. Separate consent will be sought for the different levels of involvement in the research: midwives will be required to consent to provide the questionnaire baseline and outcome data, to participate in the intervention sessions and to participate in the focus groups; pregnant women will be required to consent to provide the questionnaire baseline data and outcome data and to participate in the interviews. Copies of the information sheets and consent forms for each stage of the research are provided in Additional fileInternalRef removed. Any amendments to the protocol will be discussed with the ethics committee to determine if a minor amendment or substantial amendment is required before any changes to trial procedures are actioned. All amendments will be reported to the R&D departments at each participating NHS Trust and will be reported in the publication of the pilot study results. The trial sponsor is Newcastle upon Tyne Hospitals NHS Foundation Trust, Ms. Amanda Tortice, Research Operations Manager, amanda.tortice@ncl.ac.uk
: This is not applicable to this pilot study as individuals will not be identified from any study report. It is planned to publish the results of this study in peer review journals and to present data at national and international meetings. Results of the study will also be reported to the sponsor and funder and will be available on their website. Midwives and pregnant women will be offered the option of receiving information about their contribution to the study at the end of the study, including a lay summary of the results. The results of this study will inform the development of a grant application for a definitive trial. Any arising publications will follow the International Committee of Medical Journal Editors requirements for authorship. No restrictions are placed on publication of the trial results.
: The authors declare that they have no competing interests.
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