<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/NCT03231553</url>
  </required_header>
  <id_info>
    <org_study_id>17065</org_study_id>
    <nct_id>NCT03231553</nct_id>
  </id_info>
  <brief_title>Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy</brief_title>
  <official_title>RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</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 trial aims to determine whether or not MiQuit (text-message support programme) is&#xD;
      effective when offered in addition to standard behavioural support for smoking cessation in&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking in pregnancy is expensive; in the UK in 2010 the annual smoking-attributable maternal&#xD;
      and infant health care costs were estimated at up to £87.5 million. In high income countries&#xD;
      13% to 25% of pregnant women smoke and rates are increasing in developing ones. In the UK in&#xD;
      2010 26% of pregnant women smoked with highest rates seen amongst younger, socially&#xD;
      disadvantaged women.&#xD;
&#xD;
      However, pregnancy is the life event which most motivates smoking cessation attempts and 50+%&#xD;
      of pregnant smokers try stopping, hence smoking cessation support offered in pregnancy is&#xD;
      likely to be especially beneficial. Regrettably, in pregnancy, there is only strong efficacy&#xD;
      evidence for using either face-to-face or 'self-help' stop smoking support. Although nicotine&#xD;
      replacement therapy (NRT) is widely-used by UK pregnant smokers this has at best, borderline&#xD;
      efficacy.&#xD;
&#xD;
      Self-help support (SHS) almost doubles the likelihood of smoking cessation in late pregnancy.&#xD;
      However SHS programmes which help pregnant smokers to quit were all developed before&#xD;
      easily-accessible technologies became widely available.&#xD;
&#xD;
      Text message SHS smoking cessation programmes are highly-acceptable; those trialled with&#xD;
      non-pregnant smokers in the US and UK have demonstrated efficacy. Unfortunately, neither&#xD;
      programme is appropriate in pregnancy as they make no mention of pregnancy which for most&#xD;
      pregnant smokers is the very reason they try quitting; consequently many pregnant smokers&#xD;
      would likely find these programmes' advice irrelevant and ignore it.&#xD;
&#xD;
      Funded by CRUK to remedy the lack of acceptable self-help cessation support for pregnant&#xD;
      smokers, we developed MiQuit, a text-message, smoking cessation SHS programme for pregnant&#xD;
      smokers. MiQuit advice is relevant to pregnancy as it is highly-tailored to gestation. We&#xD;
      evaluated MiQuit in two RCTs. The first CRUK-funded trial (n=207) demonstrated acceptability.&#xD;
      Subsequently, with NIHR funding we refined MiQuit and tested this in a second RCT which&#xD;
      demonstrated the feasibility of recruiting from UK National Health Service (NHS) settings to&#xD;
      a multi-centre RCT. Again estimated efficacy was encouraging; in MiQuit and control groups,&#xD;
      prolonged abstinence from smoking, validated in late pregnancy was 5.4% and 2.0%&#xD;
      respectively.&#xD;
&#xD;
      To efficiently determine whether or not MiQuit works for smoking cessation, we are conducting&#xD;
      a third RCT with an almost identical design. The efficacy of the MiQuit system will be&#xD;
      assessed by combining the findings, using Trial Sequential Analysis methods, from this trial&#xD;
      with the findings from the previous two MiQuit trials. Without requiring an expensive, large&#xD;
      RCT this study will tell whether or not MiQuit is efficacious for smoking cessation in&#xD;
      pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported abstinence from smoking</measure>
    <time_frame>36 weeks gestation</time_frame>
    <description>Self-reported smoking abstinence from 4 weeks after enrolment until 36 weeks gestation, with no more than 5 cigarettes smoked in total between these time points, as reported and biochemically validated at 36 weeks using a cut-point used in the previous two trials.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported abstinence from smoking at 4 weeks after randomisation</measure>
    <time_frame>4 weeks after enrolment</time_frame>
    <description>7 day abstinence reported at 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abstinence from smoking at 36 weeks gestation</measure>
    <time_frame>36 weeks gestation</time_frame>
    <description>self-reported and biochemically validated 7 day abstinence at 36 weeks gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of stop-smoking services</measure>
    <time_frame>36 weeks gestation</time_frame>
    <description>use of stop-smoking services</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of NHS care</measure>
    <time_frame>At delivery</time_frame>
    <description>Use of NHS care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>At delivery</time_frame>
    <description>Weight of infant at birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age</measure>
    <time_frame>At delivery</time_frame>
    <description>Gestational age at birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal death</measure>
    <time_frame>At delivery</time_frame>
    <description>Miscarriage or stillbirth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal death</measure>
    <time_frame>At delivery</time_frame>
    <description>Death of participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status - baseline</measure>
    <time_frame>At hospital ante-natal appointment</time_frame>
    <description>Health status measured by EQ-5D-5L at baseline visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status - 4 weeks after randomisation</measure>
    <time_frame>4 weeks post randomisation</time_frame>
    <description>Health status measured by EQ-5D-5L at 4 weeks post randomisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status - 36 weeks gestation</measure>
    <time_frame>36 weeks gestation</time_frame>
    <description>Health status measured by EQ-5D-5L at 36 weeks gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal hospital admissions</measure>
    <time_frame>At delivery</time_frame>
    <description>Hospital admission of participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant hospital admission</measure>
    <time_frame>At delivery</time_frame>
    <description>Hospital admission of infant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff costs</measure>
    <time_frame>Upto 40 weeks after enrolment</time_frame>
    <description>Overheads and other consumables required to deliver the MiQuit intervention and usual care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking.&#xD;
Receive MiQuit text message cessation programme.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MiQuit text message support programme</intervention_name>
    <description>MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant and less than 25 weeks gestation&#xD;
&#xD;
          -  Smoking at least 5 cigarettes per day pre-pregnancy&#xD;
&#xD;
          -  Smoking at least 1 cigarette on a typical day during pregnancy&#xD;
&#xD;
          -  Aged 16 or over&#xD;
&#xD;
          -  Agrees to accept information to assist cessation&#xD;
&#xD;
          -  Owns or has primary use of a mobile phone&#xD;
&#xD;
          -  Familiar with sending and receiving text messages&#xD;
&#xD;
          -  Able to understand written English (text messages are in English only) and consent&#xD;
             issues explained in English.&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already enrolled in another text service to assist smoking cessation&#xD;
&#xD;
          -  Already enrolled in a smoking cessation study&#xD;
&#xD;
          -  Having already participated in the study in an earlier pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tim Coleman</last_name>
    <role>Study Director</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG1 5LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Womens NHS Foundation Trust</name>
      <address>
        <city>Edgbaston</city>
        <state>Birmingham</state>
        <zip>B15 2TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Cheshire Hospitals NHS Trust</name>
      <address>
        <city>Crewe</city>
        <state>Cheshire</state>
        <zip>CW1 4QJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Cumbria University Hospitals NHS Trust</name>
      <address>
        <city>Carlisle</city>
        <state>Cumbria</state>
        <zip>CA2 7HY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Derby and Burton NHS Foundation Trust</name>
      <address>
        <city>Derby</city>
        <state>Derbyshire</state>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8D</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennine Acute Hospitals NHS Trust</name>
      <address>
        <city>Multiple Locations</city>
        <state>Greater Manchester</state>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Lancashire Hospitals NHS Trust</name>
      <address>
        <city>Burnley</city>
        <state>Lancashire</state>
        <zip>BB10 2PQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Lincolnshire Hospitals Trust</name>
      <address>
        <city>Multiple Locations</city>
        <state>Lincolnshire</state>
        <zip>LN2 5QY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle</city>
        <state>Newcastle Upon Tyne</state>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sherwood Forest Hospitals NHS Trust</name>
      <address>
        <city>Mansfield</city>
        <state>Nottinghamshire</state>
        <zip>NG17 4JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of North Midlands NHS Trust</name>
      <address>
        <city>Stoke-on-Trent</city>
        <state>Staffordshire</state>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northumbria Healthcare NHS Foundation Trust</name>
      <address>
        <city>North Shields</city>
        <state>Tyne And Wear</state>
        <zip>NE29 8NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <zip>B75 7RR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Countess of Chester Hospital NHS Foundation Trust</name>
      <address>
        <city>Chester</city>
        <zip>CH2 1UL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospitals Sunderland NHS Foundation Trust</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>April 20, 2020</last_update_submitted>
  <last_update_submitted_qc>April 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03231553
org study id: 17065
nct id: NCT03231553
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial aims to determine whether or not MiQuit (text-message support programme) is
      effective when offered in addition to standard behavioural support for smoking cessation in
      pregnancy.
Smoking in pregnancy is expensive; in the UK in 2010 the annual smoking-attributable maternal
      and infant health care costs were estimated at up to £87.5 million. In high income countries
      13% to 25% of pregnant women smoke and rates are increasing in developing ones. In the UK in
      2010 26% of pregnant women smoked with highest rates seen amongst younger, socially
      disadvantaged women.

      However, pregnancy is the life event which most motivates smoking cessation attempts and 50+%
      of pregnant smokers try stopping, hence smoking cessation support offered in pregnancy is
      likely to be especially beneficial. Regrettably, in pregnancy, there is only strong efficacy
      evidence for using either face-to-face or 'self-help' stop smoking support. Although nicotine
      replacement therapy (NRT) is widely-used by UK pregnant smokers this has at best, borderline
      efficacy.

      Self-help support (SHS) almost doubles the likelihood of smoking cessation in late pregnancy.
      However SHS programmes which help pregnant smokers to quit were all developed before
      easily-accessible technologies became widely available.

      Text message SHS smoking cessation programmes are highly-acceptable; those trialled with
      non-pregnant smokers in the US and UK have demonstrated efficacy. Unfortunately, neither
      programme is appropriate in pregnancy as they make no mention of pregnancy which for most
      pregnant smokers is the very reason they try quitting; consequently many pregnant smokers
      would likely find these programmes' advice irrelevant and ignore it.

      Funded by CRUK to remedy the lack of acceptable self-help cessation support for pregnant
      smokers, we developed MiQuit, a text-message, smoking cessation SHS programme for pregnant
      smokers. MiQuit advice is relevant to pregnancy as it is highly-tailored to gestation. We
      evaluated MiQuit in two RCTs. The first CRUK-funded trial (n=207) demonstrated acceptability.
      Subsequently, with NIHR funding we refined MiQuit and tested this in a second RCT which
      demonstrated the feasibility of recruiting from UK National Health Service (NHS) settings to
      a multi-centre RCT. Again estimated efficacy was encouraging; in MiQuit and control groups,
      prolonged abstinence from smoking, validated in late pregnancy was 5.4% and 2.0%
      respectively.

      To efficiently determine whether or not MiQuit works for smoking cessation, we are conducting
      a third RCT with an almost identical design. The efficacy of the MiQuit system will be
      assessed by combining the findings, using Trial Sequential Analysis methods, from this trial
      with the findings from the previous two MiQuit trials. Without requiring an expensive, large
      RCT this study will tell whether or not MiQuit is efficacious for smoking cessation in
      pregnancy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Self-reported abstinence from smoking
time frame: 36 weeks gestation
description: Self-reported smoking abstinence from 4 weeks after enrolment until 36 weeks gestation, with no more than 5 cigarettes smoked in total between these time points, as reported and biochemically validated at 36 weeks using a cut-point used in the previous two trials.
measure: Self-reported abstinence from smoking at 4 weeks after randomisation
time frame: 4 weeks after enrolment
description: 7 day abstinence reported at 4 weeks
measure: Abstinence from smoking at 36 weeks gestation
time frame: 36 weeks gestation
description: self-reported and biochemically validated 7 day abstinence at 36 weeks gestation
measure: Use of stop-smoking services
time frame: 36 weeks gestation
description: use of stop-smoking services
measure: Use of NHS care
time frame: At delivery
description: Use of NHS care
measure: Birth weight
time frame: At delivery
description: Weight of infant at birth
measure: Gestational age
time frame: At delivery
description: Gestational age at birth
measure: Fetal death
time frame: At delivery
description: Miscarriage or stillbirth
measure: Maternal death
time frame: At delivery
description: Death of participant
measure: Health Status - baseline
time frame: At hospital ante-natal appointment
description: Health status measured by EQ-5D-5L at baseline visit
measure: Health Status - 4 weeks after randomisation
time frame: 4 weeks post randomisation
description: Health status measured by EQ-5D-5L at 4 weeks post randomisation
measure: Health Status - 36 weeks gestation
time frame: 36 weeks gestation
description: Health status measured by EQ-5D-5L at 36 weeks gestation
measure: Maternal hospital admissions
time frame: At delivery
description: Hospital admission of participant
measure: Infant hospital admission
time frame: At delivery
description: Hospital admission of infant
measure: Staff costs
time frame: Upto 40 weeks after enrolment
description: Overheads and other consumables required to deliver the MiQuit intervention and usual care
arm group label: Intervention
arm group type: Experimental
description: Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking.
Receive MiQuit text message cessation programme.
arm group label: Control
arm group type: No Intervention
description: Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking.
intervention type: Other
intervention name: MiQuit text message support programme
description: MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.
arm group label: Intervention
criteria: 
gender: Female
gender based: Yes
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Tim Coleman
role: Study Director
affiliation: University of Nottingham
facility: 
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country: United Kingdom
responsible party type: Sponsor
sharing ipd: No