Smoking CessationSKIP-ITNCT03272113
SKIP-IT Smoking Cessation in Pregnancy
A study testing SKIP-IT in people with Smoking Cessation and Pregnancy Related, run by University of Stirling at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Smoking Cessation, Pregnancy Related
- What is being tested?
- SKIP-IT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Dec 2017to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Smoking Cessation, Pregnancy Related
- Being tested
- SKIP-IT
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKIP-ITBehavioural
A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention | Experimental | Women will receive usual care as described above plus the SKIP-IT intervention Receives: Behavioral: SKIP-IT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
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).
Measured: 23 months
Drop out rate
Progression to a full trial will require <30% dropout
Measured: 23 months
Direction of effect
Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.
Measured: 23 months
Secondary outcomes (2)
Engagement
Engagement in the intervention will be assessed using data captured by the computer system which monitors the text message responses.
Measured: 23 months
Acceptability
Acceptability of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start5 Dec 2017
- Primary completion16 Oct 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behaviour change
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Collaborators
- Glasgow Caledonian University, University of Dundee, University of Southampton, Edinburgh Napier University
- Responsible party
- Principal investigator, Helen Cheyne, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272113
- Sponsor's protocol ID
- RMS2119
- Other IDs
- HIPS/16/4
- Acronym
- SKIP-IT
- Status last verified
- Mar 2020
- First submitted
- 29 Aug 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03272113
- Acronym / sponsor ID
- SKIP-IT / RMS2119
- Conditions
- Smoking Cessation, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Collaborators
- Glasgow Caledonian University, University of Dundee, University of Southampton, Edinburgh Napier University
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Behaviour change
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention | Experimental | Behavioral: SKIP-ITWomen will receive usual care as described above plus the SKIP-IT intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKIP-ITA theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging. | Behavioural | Intervention |
Primary outcome
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).
Drop out rate
Time frame: 23 months
Progression to a full trial will require <30% dropout
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.
2 secondary outcomes
Engagement
Time frame: 23 months
Acceptability
Time frame: 23 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKIP-IT in people with Smoking Cessation and Pregnancy Related, run by University of Stirling at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 23 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.