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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe MiQuit study: feasibility trial of a computer-tailored smoking cessation intervention providing individualised written and mobile phone text message support to pregnant smokers
Study acronymMiQuit
Study objectivesThe 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) studiedSmoking in pregnancy
Intervention1. 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 typeOther
Primary outcome measureSelf-reported ratings of acceptability, usefulness and disengagement from the intervention, measured at 12 weeks.
Secondary outcome measures1. 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 date15/11/2008
Completion date31/08/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants200
Key inclusion criteria1. 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 criteria1. Deemed unable to give informed consent
2. Unable to understand written English
Date of first enrolment15/11/2008
Date of final enrolment31/08/2009

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

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, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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