Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

MiQuit Trial: Tailored Text Messages for Pregnant Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT02043509
First received: January 14, 2014
Last updated: December 18, 2014
Last verified: December 2014
  Purpose

The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).

These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.


Condition Intervention
Pregnancy
Smoking During Pregnancy
Behavioral: MiQuit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Self-reported abstinence from smoking [ Time Frame: 36 weeks gestation ] [ Designated as safety issue: No ]
    The primary smoking outcome measure will be self-reported, continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation.


Secondary Outcome Measures:
  • 7-day point prevalence of abstinence from smoking [ Time Frame: 36 weeks gestation ] [ Designated as safety issue: No ]
    The number of short-term, 7-day point prevalence of abstinence from smoking, from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation).

  • Number of 24 hour quit attempts [ Time Frame: 36 weeks gestation ] [ Designated as safety issue: No ]
    Number of short-term, 24 hour quit attempts noted , from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation).

  • Reported use of NHS cessation support [ Time Frame: 36 weeks gestation ] [ Designated as safety issue: No ]
    Reported use of any NHS cessation support , from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation).

  • Social cognitive variables including health beliefs and outcome expectancies, self-efficacy and intentions and determination to quit/remain abstinent [ Time Frame: 36 weeks gestation ] [ Designated as safety issue: No ]
    Social cognitive variables including health beliefs and outcome expectancies, self-efficacy and intentions and determination to quit/remain abstinent, from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation).

  • Numbers of interactions with MiQuit for tailoring of content [ Time Frame: 36 weeks gestation ] [ Designated as safety issue: No ]
    Numbers of interactions with MiQuit for tailoring of content, from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation).

  • Numbers of requests to increase, decrease or stop text support [ Time Frame: 36 weeks gestation ] [ Designated as safety issue: No ]
    Numbers of requests to increase, decrease or stop text support, from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation).

  • Numbers of interactions with MiQuit for requesting on demand text support or distraction [ Time Frame: 36 weeks gestation ] [ Designated as safety issue: No ]
    Numbers of interactions with MiQuit for requesting on demand text support or distraction, from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation).


Enrollment: 407
Study Start Date: February 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MiQuit
12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care
Behavioral: MiQuit
MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement.
No Intervention: Control
Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking

Detailed Description:

Epidemiological evidence indicates that smoking during pregnancy increases the risk of many pregnancy related complications and is associated with many adverse postnatal problems. Around 15% of women still smoke throughout their pregnancy; younger women and those from more deprived backgrounds are much more likely to smoke. Behavioural support, available through NHS Stop Smoking Services, is effective but only accessed by a minority of smokers with most trying to quit alone. For this large group, self-help interventions may be an effective alternative.

MiQuit is a 12 week tailored, self-help, text-message intervention developed for pregnant smokers. A pilot study found this was feasible and acceptable for recipients, thus if MiQuit could have such an impact in routine NHS care, its low cost would make it highly cost-effective.

Before MiQuit could be used in routine care, a definitive randomised controlled trial (RCT) would be needed but currently there is insufficient information to justify conducting this.

This pilot trial will investigate whether it is possible to evaluate MiQuit in a multi-centre RCT located within the NHS, using research network resources. This study will recruit 400 pregnant smokers who will be randomly allocated to either MiQuit or control, and will provide estimates for the parameters required for determining the necessary resources for a definitive trial. These include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of trial participants in later pregnancy and ascertainment rates obtained; and the likely effect of MiQuit when women are offered this in NHS settings.

Secondary objectives include; To estimate and model the likely effectiveness and cost effectiveness of MiQuit compared with usual care including a generic smoking cessation information leaflet; To document participants' use of MiQuit interactive features and of NHS cessation support; To assess the effect of MiQuit on social cognitive determinants of quitting smoking and; To explore participant views and experiences of using MiQuit.

The participants will be recruited before 25 weeks gestation when they attend NHS hospital clinics for routine antenatal ultrasound scans. Recruitment will take place in around 12 United Kingdom (UK) centres over a 12 month period. Follow-up will be via telephone at 1 month after randomization and again at week 36 gestation. The follow-up is over a 9 month period. If a participant reports they have stopped smoking, this "quit" will be validated with a exhaled Carbon Monoxide (CO) measurement and/or salivary cotinine measurement.

A small number of semi-structured telephone interviews will be carried out with a selection of participants from the MiQuit arm to explore their views and experience of the intervention.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant and less than 25 weeks gestation
  • Smoking at least 5 cigarettes per day pre-pregnancy
  • Smoking at least 1 cigarette on a typical day during pregnancy
  • Aged 16 or over
  • Agrees to accept information to assist cessation
  • Has own or has primary use of a mobile phone
  • Familiar with sending and receiving text messages
  • Able to understand written English (text messages are in English only) and consent issues explained in English.
  • Able to give informed consent

Exclusion Criteria:

•Already enrolled in another text service to assist smoking cessation

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043509

Locations
United Kingdom
Mid Cheshire Hospitals NHS Foundation Trust
Crewe, Cheshire, United Kingdom, CW1 4QJ
Chesterfield Royal Hospitals NHS Foundation Trust
Chesterfield, Derbyshire, United Kingdom, S44 5BL
Derby Hospitals NHS Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3NE
United Lincolnshire Hospitals NHS Trust
Boston, Lincolnshire, United Kingdom, PE21 9QS
United Lincolnshire Hospitals NHS Trust
Lincoln, Lincolnshire, United Kingdom, LN12 5QY
Nottingham University Hospitals NHS Trust, City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Nottingham University Hospitals NHS Trust, QMC
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
University Hospital of North Staffordhsire NHS Trust
Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG
Birmingham Womens NHS Foundation Trust
Birmingham, W Midlands, United Kingdom, B15 2TG
Sandwell & West Birmingham Hospitals NHS Trust
Birmingham, West Midlands, United Kingdom, B18 7QH
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, United Kingdom, DY1 2HQ
Heart of England NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
Central Manchester University Hosptitals NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
University Hospitals North Midlands NHS Trust
Stafford, United Kingdom, ST16 3SA
Sponsors and Collaborators
University of Nottingham
University of Cambridge
Investigators
Study Chair: Tim Coleman, Professor University of Nottingham
  More Information

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02043509     History of Changes
Other Study ID Numbers: 13113, 13/EM/0427
Study First Received: January 14, 2014
Last Updated: December 18, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
smoking cessation
pregnancy
cessation support
tailored text messages
self-help
MiQuit

ClinicalTrials.gov processed this record on February 27, 2015