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Completed

NCT Number: NCT03272113

SKIP-IT Smoking Cessation in Pregnancy

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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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NHS Ayrshire and Arran, Ayr, United Kingdom

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About this study

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:

  • To assess acceptability and willingness to be randomised to the narrative and image based intervention or usual care.
  • To assess and compare the feasibility of recruitment strategies, the level of participants' retention in the study and engagement with the intervention.
  • To assess the acceptability and likely impact of the intervention among pregnant smokers.
  • To estimate the required sample size for a full trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women 16 years of age or over,
  • Live within the catchment areas of study sites,
  • Up to and including 14 weeks of pregnancy,
  • Current smoker,
  • Own or regularly use a mobile phone with media capability,
  • Understand written English,
  • Able to give informed consent.

Exclusion criteria

  • Women who do not currently smoke,
  • Live outside the catchment areas of study sites,
  • Over 14 weeks of pregnancy,
  • Do not use or have access to a mobile phone with media capability,
  • Cannot understand written English,
  • Not able to give informed consent,
  • Already enrolled in an alternative formal smoking cessation trial at the time of referral to the study.

Treatment and study plan

SKIP-IT

Behavioral

A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.

Primary outcomes

  1. Recruitment rate

    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).

  2. Drop out rate

    Time frame: 23 months

    Progression to a full trial will require <30% dropout

  3. Direction of effect

    Time frame: 23 months

    Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.

Secondary outcomes

  1. Engagement

    Time frame: 23 months

    Engagement in the intervention will be assessed using data captured by the computer system which monitors the text message responses.

  2. Acceptability

    Time frame: 23 months

    Acceptability of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points

Other outcomes

  1. Smoking cessation outcomes

    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)

    • 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]

Sponsors and collaborators

Lead sponsor

University of Stirling

Other

Collaborators

  • Edinburgh Napier University
  • Glasgow Caledonian University
  • University of Dundee
  • University of Southampton

Registry information

Official study 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

Acronym: SKIP-IT

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 5, 2017
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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