<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272113</url>
  </required_header>
  <id_info>
    <org_study_id>RMS2119</org_study_id>
    <secondary_id>HIPS/16/4</secondary_id>
    <nct_id>NCT03272113</nct_id>
  </id_info>
  <brief_title>SKIP-IT Smoking Cessation in Pregnancy</brief_title>
  <acronym>SKIP-IT</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Stirling</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glasgow Caledonian University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Dundee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Edinburgh Napier University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Stirling</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the feasibility and likelihood of success of a&#xD;
      narrative and image-based intervention, administered via text messages, for smoking cessation&#xD;
      in pregnant women, prior to undertaking a large scale trial of its effectiveness. A&#xD;
      feasibility and pilot trial will be undertaking involving 70 pregnant women who smoke in two&#xD;
      NHS Boards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking during pregnancy carries serious risks to mother and infant health. More babies whose&#xD;
      mothers smoke are stillborn or die within the first year of life. Smoking during pregnancy&#xD;
      results in increased rates of intrauterine growth retardation, preterm birth, and babies'&#xD;
      longer-term risk of developing heart disease and diabetes. Pregnant women who smoke are more&#xD;
      likely to experience miscarriage, placental abruption, pregnancy-induced hypertension and&#xD;
      later conditions such as lung cancer and heart disease.&#xD;
&#xD;
      Reduction in smoking in pregnancy has been a long standing health policy target however there&#xD;
      is limited evidence of effectiveness of many smoking cessation interventions and their uptake&#xD;
      is generally low. We have developed, and carried out initial testing of an intervention to&#xD;
      support smoking cessation in pregnant women using narrative, story-telling delivered via&#xD;
      automated text-messages. The intervention aims to alter women's perceptions of risk, social&#xD;
      norms, outcomes and self-efficacy using three key elements. 1. a narrative story of a&#xD;
      fictional young pregnant woman 'Megan' trying to stop smoking by overcoming a series of&#xD;
      commonplace barriers. 2) images showing the size of their fetus and its stage of development&#xD;
      3) an interactive 'help' function to receive a supportive, tailored response. Behaviour&#xD;
      change techniques for smoking cessation in pregnancy are embedded in the intervention.&#xD;
&#xD;
      A randomised controlled trial is required to test the effectiveness of the intervention in&#xD;
      reducing smoking in pregnancy. The aim of this study is to investigate the feasibility and&#xD;
      likelihood of success of the narrative and image-based intervention for smoking cessation in&#xD;
      pregnant women. If successful the intervention will be tested in a full-scale (Phase III)&#xD;
      multi centre randomised controlled trial.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To assess acceptability and willingness to be randomised to the narrative and image&#xD;
           based intervention or usual care.&#xD;
&#xD;
        2. To assess and compare the feasibility of recruitment strategies, the level of&#xD;
           participants' retention in the study and engagement with the intervention.&#xD;
&#xD;
        3. To assess the acceptability and likely impact of the intervention among pregnant&#xD;
           smokers.&#xD;
&#xD;
        4. To estimate the required sample size for a full trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2017</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 16, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Behaviour change</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>23 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drop out rate</measure>
    <time_frame>23 months</time_frame>
    <description>Progression to a full trial will require &lt;30% dropout</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Direction of effect</measure>
    <time_frame>23 months</time_frame>
    <description>Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Engagement</measure>
    <time_frame>23 months</time_frame>
    <description>Engagement in the intervention will be assessed using data captured by the computer system which monitors the text message responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>23 months</time_frame>
    <description>Acceptability of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Smoking cessation outcomes</measure>
    <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)</time_frame>
    <description>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]&#xD;
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]</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will receive usual care as described above plus the SKIP-IT intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SKIP-IT</intervention_name>
    <description>A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women 16 years of age or over,&#xD;
&#xD;
          2. Live within the catchment areas of study sites,&#xD;
&#xD;
          3. Up to and including 14 weeks of pregnancy,&#xD;
&#xD;
          4. Current smoker,&#xD;
&#xD;
          5. Own or regularly use a mobile phone with media capability,&#xD;
&#xD;
          6. Understand written English,&#xD;
&#xD;
          7. Able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who do not currently smoke,&#xD;
&#xD;
          2. Live outside the catchment areas of study sites,&#xD;
&#xD;
          3. Over 14 weeks of pregnancy,&#xD;
&#xD;
          4. Do not use or have access to a mobile phone with media capability,&#xD;
&#xD;
          5. Cannot understand written English,&#xD;
&#xD;
          6. Not able to give informed consent,&#xD;
&#xD;
          7. Already enrolled in an alternative formal smoking cessation trial at the time of&#xD;
             referral to the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NHS Ayrshire and Arran</name>
      <address>
        <city>Ayr</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Tayside</name>
      <address>
        <city>Perth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Stirling</investigator_affiliation>
    <investigator_full_name>Helen Cheyne</investigator_full_name>
    <investigator_title>Professor of Maternal and Child Health Research</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272113
org study id: RMS2119
secondary id: HIPS/16/4
nct id: NCT03272113
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Behaviour change
primary purpose: Health Services Research
masking: None (Open Label)
measure: Recruitment rate
time frame: 23 months
description: 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).
measure: Drop out rate
time frame: 23 months
description: Progression to a full trial will require <30% dropout
measure: Direction of effect
time frame: 23 months
description: Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.
measure: Engagement
time frame: 23 months
description: Engagement in the intervention will be assessed using data captured by the computer system which monitors the text message responses.
measure: Acceptability
time frame: 23 months
description: Acceptability of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points
measure: 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)
description: 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]
arm group label: Control
arm group type: No Intervention
description: 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.
arm group label: Intervention
arm group type: Experimental
description: Women will receive usual care as described above plus the SKIP-IT intervention
intervention type: Behavioral
intervention name: SKIP-IT
description: A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
arm group label: Intervention
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Stirling
investigator full name: Helen Cheyne
investigator title: Professor of Maternal and Child Health Research