Contact information
Type
Scientific
Primary contact
Prof Stephen Sutton
ORCID ID
Contact details
General Practice & Primary Care Research Unit
Institute of Public Health
University of Cambridge
Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom
-
srs34@medschl.cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MiQuit v1.4
Study information
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
Acronym
MiQuit
Study hypothesis
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
Cambridgeshire 4 NHS Research Ethics Committee, 29/08/2008, ref: 08/H0305/38
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
15/11/2008
Overall trial end date
31/08/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Deemed unable to give informed consent
2. Unable to understand written English
Recruitment start date
15/11/2008
Recruitment end date
31/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Public Health
Cambridge
CB2 0SR
United Kingdom
Sponsor information
Organisation
University of Cambridge (UK)
Sponsor details
c/o Pamela Nunez
Research Services Division
16 Mill Lane
Cambridge
CB2 1SB
United Kingdom
+44 (0)1223 333543
pamela.nunez@rsd.cam.ac.uk
Sponsor type
University/education
Website
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
c/o Dr Claudia Rizzini
Research and Development Department
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
44 (0)1223 596377
r&denquiries@addenbrookes.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C1345/A5809)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22311960