ISRCTN ISRCTN89652750
DOI https://doi.org/10.1186/ISRCTN89652750
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Integrated Research Application System (IRAS) 336985
Protocol serial number IRAS 336985
Sponsor University of Manchester
Funder Medical Research Council
Submission date
25/07/2024
Registration date
02/08/2024
Last edited
04/09/2025
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
In pregnancy, poor health behaviours, such as smoking, alcohol consumption, poor diet, lack of physical activity and non-adherence to vaccination, contribute to adverse pregnancy outcomes. However, pregnant women continue to engage in unhealthy behaviours. Pregnancy has been identified as a Teachable Moment, as it is a life event that presents an opportunity for health behaviour change. As the primary maternity care provider for most women, midwives are in an optimal position to support women with this behaviour change. However, midwives find these conversations challenging and de-prioritise them in clinical practice. The quality and success of behaviour change conversations are heavily impacted by the communication of the health professional. One aspect of communication, where there has been little attention in midwifery research, is the language used within these interactions. Evidence has shown that language is powerful within midwife-woman interactions, however, research has not yet explored the language used by midwives when discussing health behaviours. Therefore, the current research aims to explore the language used by midwives in health behaviour change discussions.

Who can participate?
Midwives who are employed by Manchester University NHS Foundation Trust and work in a hospital antenatal clinic or the community, providing antenatal booking appointments. Pregnant women aged over 16 years of age who attend their antenatal booking appointment.

What does the study involve?
To explore the language used by midwives in health behaviour change discussions, antenatal booking appointments in hospital and community antenatal clinics will be audio-recorded and the data analysed using qualitative methods.

What are the possible benefits and risks of participating?
It is hoped that by exploring midwives’ language, areas to target for improvement can be identified and an intervention developed.

Where is the study run from?
University of Manchester

When is the study starting and how long is it expected to run for?
July 2024 to December 2025

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Hannah Talbot, hannah.talbot-3@postgrad.manchester.ac.uk

Contact information

Miss Hannah Talbot
Public, Scientific, Principal investigator

Coupland 1 Building
University of Manchester
Oxford Rd
Manchester
M13 9PL
United Kingdom

ORCiD logoORCID ID 0009-0009-6515-4725
Phone N/A
Email hannah.talbot-3@postgrad.manchester.ac.uk

Study information

Primary study designObservational
Study designSingle-centre qualitative observational study
Secondary study designQualitative study
Study type Participant information sheet
Scientific titleAn observational study of the language used by midwives in health behaviour change interactions within the antenatal booking appointment.
Study objectivesWhat language do midwives use when discussing health behaviour change in the antenatal booking appointment?
Ethics approval(s)

Approved 24/10/2024, London – Bromley Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8118; bromley.rec@hra.nhs.uk), ref: 24/LO/0693

Health condition(s) or problem(s) studiedHealth behaviour change language used by midwives
InterventionThe PI will audio-record antenatal booking appointments and all data relating to health behaviours will be extracted from the transcripts and analysed using qualitative inductive content analysis. There will also be an element of deductive analysis, such as the Behaviour Change Counselling Index (BECCI), used to record aspects of the behaviour change communication.
Intervention typeBehavioural
Primary outcome measure(s)

The health behaviour change language used by midwives measured using data collected and analysed during antenatal appointments at one time point

Key secondary outcome measure(s)

There are no secondary outcome measures

Completion date01/12/2025

Eligibility

Participant type(s)Patient, Service user
Age groupMixed
Lower age limit16 Years
Upper age limit70 Years
SexAll
Target sample size at registration80
Total final enrolment33
Key inclusion criteriaMidwife participants
1. Active NMC registration
2. Employed by Manchester University NHS Foundation Trust
3. Work in a hospital antenatal clinic or in the community, providing antenatal booking appointments

Pregnant women
1. Over 16 years of age
2. Attending their antenatal booking appointment.
Key exclusion criteriaMidwives
1. No exclusion criteria

Pregnant women
2. Women who are under 16 years of age
Date of first enrolment01/12/2024
Date of final enrolment17/07/2025

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Manchester University NHS Foundation Trust
Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
IPD sharing planThe datasets generated and analysed during the current study will be published in a peer-reviewed journal in the form of anonymised direct quotations. Participants will provide written informed consent for this data sharing.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

04/09/2025: The date of final enrolment was changed from 22/09/2025 to 17/07/2025; and, the total final enrolment was added.
06/11/2024: The ethics approval date was added and the recruitment start date was changed from 01/11/2024 to 01/12/2024.
11/10/2024: The ethics submission date was added and the recruitment start date was changed from 02/09/2024 to 01/11/2024.
30/07/2024: Study's existence confirmed by the Medical Research Council.