NCT02043509

Brief Summary

The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit). These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

July 15, 2019

Completed
Last Updated

July 15, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

January 14, 2014

Results QC Date

April 30, 2019

Last Update Submit

April 30, 2019

Conditions

PregnancySmoking

Keywords

smoking cessationpregnancycessation supporttailored text messagesself-helpMiQuit

Outcome Measures

Primary Outcomes (1)

  • Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.

    The primary smoking outcome measure will be the number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.

    36 weeks gestation

Secondary Outcomes (9)

  • Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report.

    36 weeks gestation

  • 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report.

    36 weeks gestation

  • 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated.

    36 weeks gestation

  • 7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report.

    4 weeks post-randomisation

  • 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report.

    36 weeks gestation

  • +4 more secondary outcomes

Study Arms (2)

MiQuit

EXPERIMENTAL

12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care

Behavioral: MiQuit

Control

NO INTERVENTION

Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking

Interventions

MiQuitBEHAVIORAL

MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement.

MiQuit

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant and less than 25 weeks gestation
  • Smoking at least 5 cigarettes per day pre-pregnancy
  • Smoking at least 1 cigarette on a typical day during pregnancy
  • Aged 16 or over
  • Agrees to accept information to assist cessation
  • Has own or has primary use of a mobile phone
  • Familiar with sending and receiving text messages
  • Able to understand written English (text messages are in English only) and consent issues explained in English.
  • Able to give informed consent

You may not qualify if:

  • Already enrolled in another text service to assist smoking cessation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Mid Cheshire Hospitals NHS Foundation Trust

Crewe, Cheshire, CW1 4QJ, United Kingdom

Location

Chesterfield Royal Hospitals NHS Foundation Trust

Chesterfield, Derbyshire, S44 5BL, United Kingdom

Location

Derby Hospitals NHS Foundation Trust

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

United Lincolnshire Hospitals NHS Trust

Boston, Lincolnshire, PE21 9QS, United Kingdom

Location

United Lincolnshire Hospitals NHS Trust

Lincoln, Lincolnshire, LN12 5QY, United Kingdom

Location

Nottingham University Hospitals NHS Trust, City Hospital

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Nottingham University Hospitals NHS Trust, QMC

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom

Location

University Hospital of North Staffordhsire NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Birmingham Womens NHS Foundation Trust

Birmingham, W Midlands, B15 2TG, United Kingdom

Location

Sandwell & West Birmingham Hospitals NHS Trust

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

The Dudley Group NHS Foundation Trust

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Heart of England NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

Location

Central Manchester University Hosptitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

University Hospitals North Midlands NHS Trust

Stafford, ST16 3SA, United Kingdom

Location

Related Publications (2)

  • Naughton F, Prevost AT, Gilbert H, Sutton S. Randomized controlled trial evaluation of a tailored leaflet and SMS text message self-help intervention for pregnant smokers (MiQuit). Nicotine Tob Res. 2012 May;14(5):569-77. doi: 10.1093/ntr/ntr254. Epub 2012 Feb 6.

    PMID: 22311960BACKGROUND

  • Cooper S, Foster K, Naughton F, Leonardi-Bee J, Sutton S, Ussher M, Leighton M, Montgomery A, Parrott S, Coleman T. Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:29. doi: 10.1186/s13063-014-0546-4.

    PMID: 25622639DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Results Point of Contact

Title
Dr Joanne Emery
Organization
University of East Anglia
joanne.emery@uea.ac.uk

Study Officials

  • Tim Coleman, Professor

    University of Nottingham

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 23, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 15, 2019

Results First Posted

July 15, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(15)