Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2017-12-05
2019-08-31
Brief Summary
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Detailed Description
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Reduction in smoking in pregnancy has been a long standing health policy target however there is limited evidence of effectiveness of many smoking cessation interventions and their uptake is generally low. We have developed, and carried out initial testing of an intervention to support smoking cessation in pregnant women using narrative, story-telling delivered via automated text-messages. The intervention aims to alter women's perceptions of risk, social norms, outcomes and self-efficacy using three key elements. 1. a narrative story of a fictional young pregnant woman 'Megan' trying to stop smoking by overcoming a series of commonplace barriers. 2) images showing the size of their fetus and its stage of development 3) an interactive 'help' function to receive a supportive, tailored response. Behaviour change techniques for smoking cessation in pregnancy are embedded in the intervention.
A randomised controlled trial is required to test the effectiveness of the intervention in reducing smoking in pregnancy. The aim of this study is to investigate the feasibility and likelihood of success of the narrative and image-based intervention for smoking cessation in pregnant women. If successful the intervention will be tested in a full-scale (Phase III) multi centre randomised controlled trial.
Objectives:
1. To assess acceptability and willingness to be randomised to the narrative and image based intervention or usual care.
2. To assess and compare the feasibility of recruitment strategies, the level of participants' retention in the study and engagement with the intervention.
3. To assess the acceptability and likely impact of the intervention among pregnant smokers.
4. To estimate the required sample size for a full trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control
Usual care to provided by smoking cessation services in the two study sites. Site one: support from a specialist advisor using motivational interviewing, one to one, group and telephone support.
Site two: a smoking cessation incentive scheme administered through community pharmacies. Women who are verified by CO testing to have stopped smoking receive £12.50 per week.
No interventions assigned to this group
Intervention
Women will receive usual care as described above plus the SKIP-IT intervention
SKIP-IT
A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
Interventions
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SKIP-IT
A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
Eligibility Criteria
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Inclusion Criteria
2. Live within the catchment areas of study sites,
3. Up to and including 14 weeks of pregnancy,
4. Current smoker,
5. Own or regularly use a mobile phone with media capability,
6. Understand written English,
7. Able to give informed consent.
Exclusion Criteria
2. Live outside the catchment areas of study sites,
3. Over 14 weeks of pregnancy,
4. Do not use or have access to a mobile phone with media capability,
5. Cannot understand written English,
6. Not able to give informed consent,
7. Already enrolled in an alternative formal smoking cessation trial at the time of referral to the study.
16 Years
FEMALE
No
Sponsors
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Glasgow Caledonian University
OTHER
University of Dundee
OTHER
University of Southampton
OTHER
Edinburgh Napier University
OTHER
University of Stirling
OTHER
Responsible Party
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Helen Cheyne
Professor of Maternal and Child Health Research
Locations
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NHS Ayrshire and Arran
Ayr, , United Kingdom
NHS Tayside
Perth, , United Kingdom
Countries
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Other Identifiers
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HIPS/16/4
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RMS2119
Identifier Type: -
Identifier Source: org_study_id
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