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Article History

Received: 17 March 2022

Accepted: 11 October 2022

First Online: 22 October 2022

Declarations

:

: This manuscript is based on Protocol version 4.2, dated 21st November 2021, approved by West Midlands–Edgbaston Research Ethics Committee (19/WM/0368, approval date 10/01/2022). The study sponsor is Birmingham Women’s and Children’s Hospital NHS Foundation Trust.The study will be conducted according to the principles of the Declaration of Helsinki and in accordance with other relevant national guidelines, regulations and acts. The Birmingham Women’s and Children’s Hospital holds the relevant insurance for this study and is the nominated sponsor for this study. A trial steering committee (TSC) provides overall supervision of this feasibility and pilot trial and ensure it is in accordance with the principles of good clinical practice and relevant regulations. The TSC agreed the trial protocol and will provide advice to the investigators on all aspects of the trial.The TSC is chaired by Professor Nadine Foster (University of Queensland). Prof. Suzanne Hagan (Glasgow Caledonian University), Prof. Helen Cheyne (University of Stirling), and Ms. Sarah Skinner (lay representative) are members. The intervention will adhere to policies and quality standards of the participating local authorities.

: Not applicable.

: SD is partially supported by the NIHR Applied Research Collaboration (ARC) South-West Peninsula. CM is partially supported by the NIHR ARC West Midlands.