SKIP-IT Smoking Cessation in Pregnancy

NCT03272113 | Completed

• 2 other identifiers: RMS2119HIPS/16/4
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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. A feasibility and pilot trial will be undertaking involving 70 pregnant women who smoke in two NHS Boards.

Conditions

Smoking Cessation; Pregnancy Related

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Engagement

  23 months

• Acceptability

  23 months

Other Outcomes (1)

• Smoking cessation outcomes

  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)

Study Arms (2)

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

Behavioral: SKIP-IT

Interventions

SKIP-IT BEHAVIORAL

A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.

Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Stirling: lead
• Glasgow Caledonian University: collaborator
• University of Dundee: collaborator
• University of Southampton: collaborator
• Edinburgh Napier University: collaborator

Study Sites (2)

NHS Ayrshire and Arran

Ayr, United Kingdom

Location

NHS Tayside

Perth, United Kingdom

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Maternal and Child Health Research

Model Details: Behaviour change

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: December 5, 2017
• Primary Completion: October 16, 2018
• Study Completion: August 31, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

GB (2)