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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Pregnancy Related
• Intervention / Treatment: Behavioral: SKIP-IT

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
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ayr, United Kingdom
    • NHS Ayrshire and Arran
  • Perth, United Kingdom
    • NHS Tayside

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	23 months
Drop out rate	Progression to a full trial will require <30% dropout	23 months
Direction of effect	Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.	23 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	Engagement in the intervention will be assessed using data captured by the computer system which monitors the text message responses.	23 months
Acceptability	Acceptability of the intervention will be assessed in short interviews conducted with intervention group participants at the follow-up points	23 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation outcomes	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]	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)

Collaborators and Investigators

• Sponsor: University of Stirling
• Collaborators: University of Southampton; University of Dundee; Glasgow Caledonian University; Edinburgh Napier University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: RMS2119; HIPS/16/4 (Other Grant/Funding Number: Scottish Government Chief Scientist Office)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No