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Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

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ClinicalTrials.gov Identifier: NCT03231553
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Pregnancy Related Other: MiQuit text message support programme Not Applicable

Detailed Description:

Smoking in pregnancy is expensive; in the UK in 2010 the annual smoking-attributable maternal and infant health care costs were estimated at up to £87.5 million. In high income countries 13% to 25% of pregnant women smoke and rates are increasing in developing ones. In the UK in 2010 26% of pregnant women smoked with highest rates seen amongst younger, socially disadvantaged women.

However, pregnancy is the life event which most motivates smoking cessation attempts and 50+% of pregnant smokers try stopping, hence smoking cessation support offered in pregnancy is likely to be especially beneficial. Regrettably, in pregnancy, there is only strong efficacy evidence for using either face-to-face or 'self-help' stop smoking support. Although nicotine replacement therapy (NRT) is widely-used by UK pregnant smokers this has at best, borderline efficacy.

Self-help support (SHS) almost doubles the likelihood of smoking cessation in late pregnancy. However SHS programmes which help pregnant smokers to quit were all developed before easily-accessible technologies became widely available.

Text message SHS smoking cessation programmes are highly-acceptable; those trialled with non-pregnant smokers in the US and UK have demonstrated efficacy. Unfortunately, neither programme is appropriate in pregnancy as they make no mention of pregnancy which for most pregnant smokers is the very reason they try quitting; consequently many pregnant smokers would likely find these programmes' advice irrelevant and ignore it.

Funded by CRUK to remedy the lack of acceptable self-help cessation support for pregnant smokers, we developed MiQuit, a text-message, smoking cessation SHS programme for pregnant smokers. MiQuit advice is relevant to pregnancy as it is highly-tailored to gestation. We evaluated MiQuit in two RCTs. The first CRUK-funded trial (n=207) demonstrated acceptability. Subsequently, with NIHR funding we refined MiQuit and tested this in a second RCT which demonstrated the feasibility of recruiting from UK National Health Service (NHS) settings to a multi-centre RCT. Again estimated efficacy was encouraging; in MiQuit and control groups, prolonged abstinence from smoking, validated in late pregnancy was 5.4% and 2.0% respectively.

To efficiently determine whether or not MiQuit works for smoking cessation, we are conducting a third RCT with an almost identical design. The efficacy of the MiQuit system will be assessed by combining the findings, using Trial Sequential Analysis methods, from this trial with the findings from the previous two MiQuit trials. Without requiring an expensive, large RCT this study will tell whether or not MiQuit is efficacious for smoking cessation in pregnancy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Receive MiQuit text message cessation programme.

Other: MiQuit text message support programme
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.

No Intervention: Control
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.



Primary Outcome Measures :
  1. Self-reported abstinence from smoking [ Time Frame: 36 weeks gestation ]
    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.


Secondary Outcome Measures :
  1. Self-reported abstinence from smoking at 4 weeks after randomisation [ Time Frame: 4 weeks after enrolment ]
    7 day abstinence reported at 4 weeks

  2. Abstinence from smoking at 36 weeks gestation [ Time Frame: 36 weeks gestation ]
    self-reported and biochemically validated 7 day abstinence at 36 weeks gestation

  3. Use of stop-smoking services [ Time Frame: 36 weeks gestation ]
    use of stop-smoking services

  4. Use of NHS care [ Time Frame: At delivery ]
    Use of NHS care

  5. Birth weight [ Time Frame: At delivery ]
    Weight of infant at birth

  6. Gestational age [ Time Frame: At delivery ]
    Gestational age at birth

  7. Fetal death [ Time Frame: At delivery ]
    Miscarriage or stillbirth

  8. Maternal death [ Time Frame: At delivery ]
    Death of participant

  9. Health Status - baseline [ Time Frame: At hospital ante-natal appointment ]
    Health status measured by EQ-5D-5L at baseline visit

  10. Health Status - 4 weeks after randomisation [ Time Frame: 4 weeks post randomisation ]
    Health status measured by EQ-5D-5L at 4 weeks post randomisation

  11. Health Status - 36 weeks gestation [ Time Frame: 36 weeks gestation ]
    Health status measured by EQ-5D-5L at 36 weeks gestation

  12. Maternal hospital admissions [ Time Frame: At delivery ]
    Hospital admission of participant

  13. Infant hospital admission [ Time Frame: At delivery ]
    Hospital admission of infant

  14. Staff costs [ Time Frame: Upto 40 weeks after enrolment ]
    Overheads and other consumables required to deliver the MiQuit intervention and usual care



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231553


Contacts
Contact: Rachel Whitemore 0115 8231899 rachel.whitemore@nottingham.ac.uk
Contact: Miranda Clark 0115 7487082 miranda.clark@nottingham.ac.uk

Locations
United Kingdom
Royal Berkshire NHS Foundation Trust Recruiting
Reading, Berkshire, United Kingdom, RG1 5LE
Contact: Fidelma Lee         
Birmingham Womens NHS Foundation Trust Recruiting
Edgbaston, Birmingham, United Kingdom, B15 2TG
Contact: Chloe O'Hara         
Mid Cheshire Hospitals NHS Trust Recruiting
Crewe, Cheshire, United Kingdom, CW1 4QJ
Contact: Janet Brown    01270 273745    janet.brown@mcht.nhs.uk   
North Cumbria University Hospitals NHS Trust Recruiting
Carlisle, Cumbria, United Kingdom, CA2 7HY
Contact: Laura Hipple         
University Hospitals of Derby and Burton NHS Foundation Trust Recruiting
Derby, Derbyshire, United Kingdom, DE22 3NE
Contact: Elaine Coulborn         
Plymouth Hospitals NHS Trust Recruiting
Plymouth, Devon, United Kingdom, PL6 8D
Contact: Heidi Hollands         
Pennine Acute Hospitals NHS Trust Recruiting
Multiple Locations, Greater Manchester, United Kingdom, M8 5RB
Contact: Rachel Newport         
East Lancashire Hospitals NHS Trust Recruiting
Burnley, Lancashire, United Kingdom, BB10 2PQ
Contact: Cathie Melvin         
United Lincolnshire Hospitals Trust Recruiting
Multiple Locations, Lincolnshire, United Kingdom, LN2 5QY
Contact: Claire Hewitt         
Newcastle Upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle, Newcastle Upon Tyne, United Kingdom, NE1 4LP
Contact: Andrea Fenn         
Sherwood Forest Hospitals NHS Trust Recruiting
Mansfield, Nottinghamshire, United Kingdom, NG17 4JL
Contact: Jyothi Rajeswary         
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Sarah Collins         
University Hospitals of North Midlands NHS Trust Recruiting
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Contact: Donna Brayford         
Northumbria Healthcare NHS Foundation Trust Recruiting
North Shields, Tyne And Wear, United Kingdom, NE29 8NH
Contact: Helen Howlett         
University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B75 7RR
Contact: Mirriam Sangombe         
Countess of Chester Hospital NHS Foundation Trust Recruiting
Chester, United Kingdom, CH2 1UL
Contact: Kerry Barker-Williams    01244 363422    kerry.barker-williams@nhs.net   
City Hospitals Sunderland NHS Foundation Trust Recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Lesley Hewitt         
Sponsors and Collaborators
University of Nottingham
Investigators
Study Director: Tim Coleman University of Nottingham

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03231553     History of Changes
Other Study ID Numbers: 17065
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No