An interventional study of SKIP-IT in Smoking Cessation and Pregnancy Related, sponsored by University of Stirling. Completed at 2 sites in United Kingdom. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by University of Stirling · Not applicable, Interventional, and Health services research
The aim of this study is to investigate the feasibility and likelihood of success of a narrative and image-based intervention, administered via text messages, for smoking cessation in pregnant women, prior to undertaking a large scale trial of its effectiveness. A feasibility and pilot trial will be undertaking involving 70 pregnant women who smoke in two NHS Boards.
Smoking during pregnancy carries serious risks to mother and infant health. More babies whose mothers smoke are stillborn or die within the first year of life. Smoking during pregnancy results in increased rates of intrauterine growth retardation, preterm birth, and babies' longer-term risk of developing heart disease and diabetes. Pregnant women who smoke are more likely to experience miscarriage, placental abruption, pregnancy-induced hypertension and later conditions such as lung cancer and heart disease.
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:
Exclusion Criteria:
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.
Women will receive usual care as described above plus the SKIP-IT intervention
Behavioral: SKIP-IT
A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
Recruitment rate
Progression to a full trial will require recruitment ≥50% of women who give permission to have their details passed to the research team (i.e. those who express initial interest in the study).
Time frame: 23 months
Drop out rate
Progression to a full trial will require \<30% dropout
Time frame: 23 months
Direction of effect
Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.
Time frame: 23 months
Engagement
Engagement in the intervention will be assessed using data captured by the computer system which monitors the text message responses.
Time frame: 23 months
Acceptability
Acceptability of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points
Time frame: 23 months
Smoking cessation outcomes
1. The Russell Standard abstinence question: if they have smoked at all since the last data collection point (with answers being reported as: 'no, not a puff; 1-5 cigarettes; more than 5 cigarettes'). \[self-reported abstinence\] 2. How many times they have purposefully not smoked for more than 24 hrs since the last data collection time point. \[Self-reported 24hr quit attempts\]
Time frame: At each subsequent data collection time-point (4 weeks post-randomisation, 36 weeks of pregnancy, 6-7 weeks post due-date, 12-13 weeks post due-date)
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Stirling