Condition category
Mental and Behavioural Disorders
Date applied
15/10/2008
Date assigned
13/11/2008
Last edited
09/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.rsd.cam.ac.uk/

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

Publication citations

Additional files

Editorial Notes