SKIP-IT Smoking Cessation in Pregnancy

University of Stirling

Status: Completed

Conditions: Pregnancy Related; Smoking Cessation

Treatments: Behavioral: SKIP-IT

Study type: Interventional

Funder types: Other

Identifiers

NCT03272113

HIPS/16/4 (Other Grant/Funding Number)

RMS2119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

Women will receive usual care as described above plus the SKIP-IT intervention

Treatment:

Behavioral: SKIP-IT