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SKIP-IT Smoking Cessation in Pregnancy (SKIP-IT)

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ClinicalTrials.gov Identifier: NCT03272113
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : December 11, 2017
Sponsor:
Collaborators:
Glasgow Caledonian University
University of Dundee
University of Southampton
Edinburgh Napier University
Information provided by (Responsible Party):
Helen Cheyne, University of Stirling

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Pregnancy Related Behavioral: SKIP-IT Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Behaviour change
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control

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.

Experimental: Intervention
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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) ]
    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]



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272113


Contacts
Contact: Helen Cheyne, PhD 01786466298 h.l.cheyne@stir.ac.uk
Contact: Emma King, PhD 01786466341 emma.king@stir.ac.uk

Locations
United Kingdom
NHS Ayrshire and Arran Recruiting
Ayr, United Kingdom
Contact: Emma King, PhD       emma.king@stir.ac.uk   
Contact: Helen Cheyne, PhD       helen.cheyne@stir.ac.uk   
NHS Tayside Recruiting
Perth, United Kingdom
Contact: Emma King, PhD       emma.king@stir.ac.uk   
Contact: Helen Cheyne, PhD       helen.cheyne@stir.ac.uk   
Sponsors and Collaborators
University of Stirling
Glasgow Caledonian University
University of Dundee
University of Southampton
Edinburgh Napier University

Responsible Party: Helen Cheyne, Professor of Maternal and Child Health Research, University of Stirling
ClinicalTrials.gov Identifier: NCT03272113     History of Changes
Other Study ID Numbers: RMS2119
HIPS/16/4 ( Other Grant/Funding Number: Scottish Government Chief Scientist Office )
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No