SKIP-IT Smoking Cessation in Pregnancy

Smoking Cessation Clinical Trial

— SKIP-IT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272113
• Other study ID #: RMS2119
• Secondary ID: HIPS/16/4
• Status: Completed
• Phase: N/A
• Start date: December 5, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2020
• Source: University of Stirling
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 31, 2019
• Est. primary completion date: October 16, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related
• Smoking Cessation

Intervention

Behavioral:
• SKIP-IT
A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.

Locations

Country	Name	City	State
United Kingdom	NHS Ayrshire and Arran	Ayr
United Kingdom	NHS Tayside	Perth

Sponsors (5)

Lead Sponsor	Collaborator
University of Stirling	Edinburgh Napier University, Glasgow Caledonian University, University of Dundee, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking cessation outcomes	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]; 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]	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)
Primary	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).	23 months
Primary	Drop out rate	Progression to a full trial will require <30% dropout	23 months
Primary	Direction of effect	Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.	23 months
Secondary	Engagement	Engagement in the intervention will be assessed using data captured by the computer system which monitors the text message responses.	23 months
Secondary	Acceptability	Acceptability of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points	23 months