The smoking cessation in pregnancy incentives trial

Conditions

Smoking during pregnancy Pregnancy and Childbirth Reproductive Health and Childbirth and smoking addiction

Jennifer McKell, Fiona Harris, Lesley Sinclair, Linda Bauld, David Tappin et al. (6 authors)

BMJ Open2022-12-018 citations

10.1136/bmjopen-2022-066494

Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial

David Tappin, Lesley Sinclair, Frank Kee, Margaret McFadden, Lyn Robinson‐Smith et al. (19 authors)

BMJ2022-10-1938 citations

10.1136/bmj-2022-071522

A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III)

Nicola McMeekin, Lesley Sinclair, Linda Bauld, David Tappin, Alex Mitchell et al. (6 authors)

BMJ Open2020-10-014 citations

10.1136/bmjopen-2020-038827

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial.

Sinclair L, McFadden M, Tilbrook H, Mitchell A, Keding A, Watson J, Bauld L, Kee F, Torgerson D, Hewitt C, McKell J, Hoddinott P, Harris FM, Uny I, Boyd K, McMeekin N, Ussher M, Tappin DM, CPIT III local research teams.

2020-02-1413 citations

10.1186/s13063-019-4042-8

Interventions

Current interventions as of 10/05/2018: Participants are randomly allocated to either the intervention or the control group. The intervention group and control group receive the offer of smoking cess

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Self-reported smoker 2. >= 16 years 3. Pregnant less than 24 weeks 4. English speaking

Exclusion criteria

Exclusion criteria: 1. Non-smoker 2. = 24 weeks 4. Non-English speaking

Design outcomes

Primary

Measure	Time frame
Self-reported abstinence from smoking for at least eight weeks prior to 34-38 weeks gestation verified by cotinine and/or anabasine in urine/saliva.	—

Secondary

Measure	Time frame
24/07/2020: Secondary outcome measures updated to include those items omitted in error at trial registration and thus correspond with the published protocol: 1. Engagement with smoking cessation services measured as having attended a first appointment with a Stop Smoking Service Advisor and setting a quit date before 26 weeks gestation 2. Biochemically validated (CO) self-reported abstinence from smoking at 4 weeks after quit date 3. Cotinine and/or anabasine verified self-reported continuous abstinence from smoking until 6 months after birth 4. Birth weight 5. Cost-effectiveness: incremental cost per late pregnancy quitter and cost per quality-adjusted life year (QALY) gained over the trial time horizon and lifetime using the EQ-5D as the measure of utility at baseline, primary and secondary outcome data collection follow-up time points 6. Process evaluation: barriers and facilitators to trial recruitment and future implementation of incentives in practice using a mixed methods longitudinal case study design informed by the realist evaluation approach Data for the primary outcome and secondary outcomes 1, 2 and 4 will be combined with data from the feasibility trial in a meta-analysis Previous secondary outcome measures listed: Cotinine and/or anabasine verified self-reported continuous abstinence from smoking until 6 months after birth, birth weight, cost effectiveness (using the EQ-5D as the measure of utility) and process evaluation.	—

Measure

Time frame

24/07/2020: Secondary outcome measures updated to include those items omitted in error at trial registration and thus correspond with the published protocol: 1. Engagement with smoking cessation services measured as having attended a first appointment with a Stop Smoking Service Advisor and setting a quit date before 26 weeks gestation 2. Biochemically validated (CO) self-reported abstinence from smoking at 4 weeks after quit date 3. Cotinine and/or anabasine verified self-reported continuous abstinence from smoking until 6 months after birth 4. Birth weight 5. Cost-effectiveness: incremental cost per late pregnancy quitter and cost per quality-adjusted life year (QALY) gained over the trial time horizon and lifetime using the EQ-5D as the measure of utility at baseline, primary and secondary outcome data collection follow-up time points 6. Process evaluation: barriers and facilitators to trial recruitment and future implementation of incentives in practice using a mixed methods longitudinal case study design informed by the realist evaluation approach Data for the primary outcome and secondary outcomes 1, 2 and 4 will be combined with data from the feasibility trial in a meta-analysis Previous secondary outcome measures listed: Cotinine and/or anabasine verified self-reported continuous abstinence from smoking until 6 months after birth, birth weight, cost effectiveness (using the EQ-5D as the measure of utility) and process evaluation.

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Countries

England, Northern Ireland, Scotland, United Kingdom

Outcome results

None listed