The MiQuit study: feasibility trial of a computer-tailored smoking cessation intervention providing individualised written and mobile phone text message support to pregnant smokers

ISRCTN	ISRCTN11301171
DOI	https://doi.org/10.1186/ISRCTN11301171
Secondary identifying numbers	MiQuit v1.4

Submission date: 15/10/2008
Registration date: 13/11/2008
Last edited: 09/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stephen Sutton
Scientific

General Practice & Primary Care Research Unit
Institute of Public Health
University of Cambridge
Forvie Site, Robinson Way
Cambridge
CB2 0SR
United Kingdom

Email	srs34@medschl.cam.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The MiQuit study: feasibility trial of a computer-tailored smoking cessation intervention providing individualised written and mobile phone text message support to pregnant smokers
Study acronym	MiQuit
Study objectives	The primary aim is to assess the feasibility and acceptability of a computer-tailored smoking cessation intervention for pregnant smokers and inform whether to progress to a definitive efficacy trial.
Ethics approval(s)	Cambridgeshire 4 NHS Research Ethics Committee, 29/08/2008, ref: 08/H0305/38
Health condition(s) or problem(s) studied	Smoking in pregnancy
Intervention	1. Standard care and a generic smoking cessation self-help leaflet 2. Standard care and an individually tailored smoking cessation self-help leaflet plus 12 weeks of individualised mobile phone text message smoking cessation support Total duration of treatment is 12 weeks (intervention group only). Follow-up time point is at 12 weeks for both arms.
Intervention type	Other
Primary outcome measure	Self-reported ratings of acceptability, usefulness and disengagement from the intervention, measured at 12 weeks.
Secondary outcome measures	1. Self-reported and biochemically validated 7-day point prevalence smoking rates, requested by text message at 4, 7 and 12 weeks 2. Self-reported repeated 7-day point prevalence rates across three time points, requested by text message at 4, 7 and 12 weeks 3. Infant birth weight, ascertained approximately 30 weeks after enrolment (depending upon number of weeks gestation at recruitment) 4. Smoking status at delivery 5. Gestation at delivery
Overall study start date	15/11/2008
Completion date	31/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	200
Key inclusion criteria	1. Pregnant 2. Aged at least 16 years of age 3. Smoking at the time of booking for maternity care 4. Owns or has the use of a mobile phone
Key exclusion criteria	1. Deemed unable to give informed consent 2. Unable to understand written English
Date of first enrolment	15/11/2008
Date of final enrolment	31/08/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Public Health

Cambridge
CB2 0SR
United Kingdom

Sponsor information

University of Cambridge (UK)
University/education

c/o Pamela Nunez
Research Services Division
16 Mill Lane
Cambridge
CB2 1SB
England
United Kingdom

Phone	+44 (0)1223 333543
Email	pamela.nunez@rsd.cam.ac.uk
Website	http://www.rsd.cam.ac.uk/

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Dr Claudia Rizzini
Research and Development Department
Box 277, Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone	44 (0)1223 596377
Email	r&denquiries@addenbrookes.nhs.uk

University of Cambridge
Not defined

Website	http://www.cam.ac.uk/
"ROR"	https://ror.org/013meh722

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C1345/A5809)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, Cancer Research UK (CRUK), CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No