Clinical trial NCT03272113: SKIP-IT Smoking Cessation in Pregnancy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Pregnancy Related
Lead sponsor: University of Stirling
Sponsor class: OTHER
Collaborators: name: Glasgow Caledonian University
name: University of Dundee
name: University of Southampton
name: Edinburgh Napier University
First posted: 2017-09-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behaviour change
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

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.

Eligibility criteria: Inclusion Criteria:

1. Women 16 years of age or over,
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:

1. Women who do not currently smoke,
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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 23 months
measure: Drop out rate
timeFrame: 23 months
measure: Direction of effect
timeFrame: 23 months
Secondary outcomes:
measure: Engagement
timeFrame: 23 months
measure: Acceptability
timeFrame: 23 months
Other outcomes:
measure: Smoking cessation outcomes
timeFrame: 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)
Locations:
city: Ayr
country: United Kingdom
facility: NHS Ayrshire and Arran
city: Perth
country: United Kingdom
facility: NHS Tayside
Study officials:
References: