{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T03:26:29Z","timestamp":1787196389657,"version":"build-2736575974"},"reference-count":32,"publisher":"BMJ","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"accepted":{"date-parts":[[2026,7,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the effectiveness of an interpersonal and digital intervention, BabyBreathe, for maintaining postpartum smoking cessation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Multicentre pragmatic individually randomised controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Community health visiting services in the UK.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>887 pregnant women and people who reported quitting smoking in the 12 months before, or during, pregnancy, with abstinence verified by exhaled carbon monoxide readings. A secure web based randomisation sequence, stratified by recruitment hub, partner smoking status, and quit timing (before or during pregnancy), was used to randomise participants (1:1) to receive the intervention or usual care. The trial was unblinded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>BabyBreathe comprised in-person or remote smoking cessation maintenance interpersonal support at 28-32 weeks\u2019 gestation and 10-14 days post partum. The BabyBreathe box, posted at the time of birth notification, contained theory driven advice for cessation maintenance, a sample of nicotine replacement gum, and motivational tools. Tailored motivational and educational text messages were provided. A website and app provided tailored cessation maintenance advice, social support, motivational tools, and gamification. Control was usual postpartum care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measure<\/jats:title>\n                    <jats:p>The primary outcome was continuous smoking abstinence, verified by exhaled carbon monoxide concentration (\u22647 parts per million (ppm)) 12 months post partum.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between 4 September 2021 and 3 August 2023, 887 participants were randomised: 442 to receive BabyBreathe and 445 to receive usual care. After one post-randomisation exclusion, 886 participants were included in an intention-to-treat analysis. The group difference in smoking abstinence at 12 months post partum was not significant (BabyBreathe 242\/441 (54.9%)\n                      <jats:italic>v<\/jats:italic>\n                      usual care 222\/445 (49.9%); odds ratio 1.23, 95% confidence interval (CI) 0.94 to 1.60, P=0.13, risk difference 4.8% (-1.7% to 11.2%), and number needed to treat (NNT) 21 (NNT to benefit 8.9 to \u221e) and NNT to harm 59). A post hoc per protocol analysis favoured the intervention (BabyBreathe 200\/347 (57.6%)\n                      <jats:italic>v<\/jats:italic>\n                      usual care 222\/445 (49.9%); adjusted odds ratio 1.36, 95% CI 1.02 to 1.81, P=0.04), risk difference 7.2% (0.3% to 14.1%), and NNT 13.9 (7.1 to 333.3). No trial related adverse incidents occurred.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>BabyBreathe did not statistically significantly increase sustained smoking abstinence post partum for people who quit smoking in pregnancy. A post hoc per protocol analysis, including only those who received interpersonal support as intended, showed statistically significantly greater benefit from BabyBreathe over usual care. A focus on fidelity and further targeting of BabyBreathe to groups with lower socioeconomic status may be warranted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ISRCTN Registry\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT70307341\">NCT70307341<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmj-2026-100242","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T03:04:39Z","timestamp":1787195079000},"page":"e100242","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Effectiveness of the BabyBreathe intervention for maintaining postpartum smoking cessation: multicentre pragmatic randomised controlled trial"],"prefix":"10.1136","volume":"394","clinical-trial-number":[{"clinical-trial-number":"nct70307341","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0876-3304","authenticated-orcid":true,"given":"Caitlin","family":"Notley","sequence":"first","affiliation":[{"name":"Faculty of Medicine and Health Sciences, Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pippa","family":"Belderson","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health Sciences, Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Clark","sequence":"additional","affiliation":[{"name":"Norwich Clinical Trials Unit, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracey J","family":"Brown","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health Sciences, Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Bauld","sequence":"additional","affiliation":[{"name":"The Usher Institute, and Behavioural Research UK, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan B","family":"Clark","sequence":"additional","affiliation":[{"name":"Norwich Clinical Trials Unit, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon","family":"Duneclift","sequence":"additional","affiliation":[{"name":"Norfolk Healthy Child Programme, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicky","family":"Gilroy","sequence":"additional","affiliation":[{"name":"Institute of Health Visiting, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tess","family":"Harris","sequence":"additional","affiliation":[{"name":"School of Health and Medical Sciences, City St George\u2019s University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Hardeman","sequence":"additional","affiliation":[{"name":"School of Health Sciences, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Holland","sequence":"additional","affiliation":[{"name":"University of Exeter, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Howard","sequence":"additional","affiliation":[{"name":"Norwich Clinical Trials Unit, Norwich Medical School, Faculty of 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