SKIP-IT
BehavioralA theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
NCT Number: NCT03272113
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.
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Notify Me16 year and older
Female
Interventional
Not applicable
NHS Ayrshire and Arran, Ayr, United Kingdom
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
Time frame: 23 months
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
Progression to a full trial will require <30% dropout
Time frame: 23 months
Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.
Time frame: 23 months
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 of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points
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)
University of Stirling
Other
Promoting Smoking Cessation During Pregnancy: a Combined Feasibility and Pilot Trial of a Theory-based Intervention Using Narrative, Images and Embedded Behaviour Change Techniques, Delivered Via Text-messaging
Acronym: SKIP-IT
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