NCT03231553

Brief Summary

The trial aims to determine whether or not MiQuit (text-message support programme) is effective when offered in addition to standard behavioural support for smoking cessation in pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

17 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

July 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

July 20, 2017

Last Update Submit

April 20, 2020

Conditions

Smoking CessationPregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Self-reported abstinence from smoking

    Self-reported smoking abstinence from 4 weeks after enrolment until 36 weeks gestation, with no more than 5 cigarettes smoked in total between these time points, as reported and biochemically validated at 36 weeks using a cut-point used in the previous two trials.

    36 weeks gestation

Secondary Outcomes (14)

  • Self-reported abstinence from smoking at 4 weeks after randomisation

    4 weeks after enrolment

  • Abstinence from smoking at 36 weeks gestation

    36 weeks gestation

  • Use of stop-smoking services

    36 weeks gestation

  • Use of NHS care

    At delivery

  • Birth weight

    At delivery

  • +9 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking. Receive MiQuit text message cessation programme.

Other: MiQuit text message support programme

Control

NO INTERVENTION

Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking.

Interventions

MiQuit text message support programmeOTHER

MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.

Intervention

Eligibility Criteria

Age16 Years+
Sexfemale(Gender-based eligibility)
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
  • Owns 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
  • Already enrolled in a smoking cessation study
  • Having already participated in the study in an earlier pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG1 5LE, United Kingdom

Location

Birmingham Womens NHS Foundation Trust

Edgbaston, Birmingham, B15 2TG, United Kingdom

Location

Mid Cheshire Hospitals NHS Trust

Crewe, Cheshire, CW1 4QJ, United Kingdom

Location

North Cumbria University Hospitals NHS Trust

Carlisle, Cumbria, CA2 7HY, United Kingdom

Location

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8D, United Kingdom

Location

Pennine Acute Hospitals NHS Trust

Multiple Locations, Greater Manchester, M8 5RB, United Kingdom

Location

East Lancashire Hospitals NHS Trust

Burnley, Lancashire, BB10 2PQ, United Kingdom

Location

United Lincolnshire Hospitals Trust

Multiple Locations, Lincolnshire, LN2 5QY, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, Newcastle Upon Tyne, NE1 4LP, United Kingdom

Location

Sherwood Forest Hospitals NHS Trust

Mansfield, Nottinghamshire, NG17 4JL, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

University Hospitals of North Midlands NHS Trust

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

Location

Northumbria Healthcare NHS Foundation Trust

North Shields, Tyne and Wear, NE29 8NH, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B75 7RR, United Kingdom

Location

Countess of Chester Hospital NHS Foundation Trust

Chester, CH2 1UL, United Kingdom

Location

City Hospitals Sunderland NHS Foundation Trust

Sunderland, SR4 7TP, United Kingdom

Location

Related Publications (2)

  • Coleman T, Clark M, Welch C, Whitemore R, Leonardi-Bee J, Cooper S, Hewitt C, Jones M, Sutton S, Watson J, Daykin K, Ussher M, Parrott S, Naughton F. Effectiveness of offering tailored text message, self-help smoking cessation support to pregnant women who want information on stopping smoking: MiQuit3 randomised controlled trial and meta-analysis. Addiction. 2022 Apr;117(4):1079-1094. doi: 10.1111/add.15715. Epub 2021 Nov 5.

    PMID: 34636086DERIVED

  • Whitemore R, Leonardi-Bee J, Naughton F, Sutton S, Cooper S, Parrott S, Hewitt C, Clark M, Ussher M, Jones M, Torgerson D, Coleman T. Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis. Trials. 2019 May 22;20(1):280. doi: 10.1186/s13063-019-3341-4.

    PMID: 31118090DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Tim Coleman

    University of Nottingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 27, 2017

Study Start

November 30, 2017

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(17)