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
Abstract Background Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smok...
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doaj-c0ee94d22650478bb051df04c4a8d9fe2020-11-25T03:21:57ZengBMCTrials1745-62152019-05-0120111310.1186/s13063-019-3341-4Effectiveness 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-analysisRachel Whitemore0Jo Leonardi-Bee1Felix Naughton2Stephen Sutton3Sue Cooper4Steve Parrott5Catherine Hewitt6Miranda Clark7Michael Ussher8Matthew Jones9David Torgerson10Tim Coleman11Division of Primary Care, University of NottinghamDivision of Epidemiology and Public Health, University of Nottingham, City HospitalSchool of Health Sciences, University of East AngliaInstitute of Public Health, University of CambridgeDivision of Primary Care, University of NottinghamDepartment of Health Sciences, Seebohm Rowntree Building, University of York, HeslingtonDepartment of Health Sciences, Seebohm Rowntree Building, University of York, HeslingtonDivision of Primary Care, University of NottinghamPopulation Health Research Institute, St. George’s, University of LondonDivision of Primary Care, University of NottinghamPopulation Health Research Institute, St. George’s, University of LondonDivision of Primary Care, University of NottinghamAbstract Background Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called ‘MiQuit’ to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit’s evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy. Methods/design This is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks’ gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks’ gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate. Discussion If effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking. Trial registration ClinicalTrials.gov, ID: NCT03231553. Registered on 20 July 2017.http://link.springer.com/article/10.1186/s13063-019-3341-4Smoking cessationPregnancySelf-helpRandomised controlled trialProtocol |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Rachel Whitemore Jo Leonardi-Bee Felix Naughton Stephen Sutton Sue Cooper Steve Parrott Catherine Hewitt Miranda Clark Michael Ussher Matthew Jones David Torgerson Tim Coleman |
spellingShingle |
Rachel Whitemore Jo Leonardi-Bee Felix Naughton Stephen Sutton Sue Cooper Steve Parrott Catherine Hewitt Miranda Clark Michael Ussher Matthew Jones David Torgerson Tim Coleman 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 Smoking cessation Pregnancy Self-help Randomised controlled trial Protocol |
author_facet |
Rachel Whitemore Jo Leonardi-Bee Felix Naughton Stephen Sutton Sue Cooper Steve Parrott Catherine Hewitt Miranda Clark Michael Ussher Matthew Jones David Torgerson Tim Coleman |
author_sort |
Rachel Whitemore |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-05-01 |
description |
Abstract Background Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called ‘MiQuit’ to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit’s evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy. Methods/design This is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks’ gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks’ gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate. Discussion If effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking. Trial registration ClinicalTrials.gov, ID: NCT03231553. Registered on 20 July 2017. |
topic |
Smoking cessation Pregnancy Self-help Randomised controlled trial Protocol |
url |
http://link.springer.com/article/10.1186/s13063-019-3341-4 |
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