{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T20:20:10Z","timestamp":1793650810371,"version":"4.5.1"},"reference-count":37,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2025,3,24]],"date-time":"2025-03-24T00:00:00Z","timestamp":1742774400000},"content-version":"unspecified","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R21HD103039"],"award-info":[{"award-number":["R21HD103039"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R33HD103039"],"award-info":[{"award-number":["R33HD103039"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,2,19]]},"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Smoking in pregnancy negatively impacts the mother\u2019s and offspring\u2019s health. Mobile health, especially mobile phone-based approaches, shows promise in supporting pregnant women to quit smoking. Our previous research indicated that support from laypersons, such as family, friends and coworkers, can increase smoking cessation. Building on these findings, we developed an innovative smartphone application (app) that combines the power of social support with artificial intelligence. The app leverages the unique functionality of smartphones and reinforcement learning (RL) to provide a deeply tailored intervention that continuously adapts while emphasising positive support through reciprocal interactions between the smoker and the support person. Herein, we report the methods used to develop, implement and test the feasibility and effectiveness of a novel adaptive mobile pregnancy tobacco cessation app-based intervention using deep tailoring and a self-nominated supporter.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The study is a type II hybrid effectiveness-implementation randomised controlled trial. In total, 300 pregnant smokers and their supporters will be randomised to (1) the SmokeFree Together 2.0 app and an RL-based intervention that continuously decides if a counselling call is needed using a fixed algorithm measuring motivation and craving or (2) a control group. The intervention will be administered throughout pregnancy up to 1\u2009month after giving birth, with a 5-month follow-up period and outcome assessments at 3-month and 6-month post partum. Cessation (primary outcome) is defined as 7-day point biochemically verified prevalence of tobacco use and abstinence since birth, assessed at 6 months post partum. The central hypothesis is that the intervention will show evidence of feasibility and effectiveness in increasing social support, pregnancy cessation and postnatal abstinence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The Institutional Review Board of Michigan State University (#IRB00000297) approved this trial. The findings will be disseminated through peer-reviewed publications and participation in scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05337722\">NCT05337722<\/jats:ext-link>\n                      . Protocol version: 1.3 from 15.05.2024.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-100259","type":"journal-article","created":{"date-parts":[[2025,3,25]],"date-time":"2025-03-25T03:24:56Z","timestamp":1742873096000},"page":"e100259","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Smartphone intervention for pregnancy smoking cessation with peer support: the study protocol of the SmokeFree Together 2.0 (SFT 2.0) randomised controlled trial"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct05337722","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05337722","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1934-2591","authenticated-orcid":false,"given":"Oana M","family":"Blaga","sequence":"first","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Biology, Michigan State University, East Lansing, Michigan, USA"},{"name":"Universitatea Babes-Bolyai, Cluj-Napoca, Romania"},{"name":"Department of Public Health, Universitatea Babes-Bolyai, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina D","family":"Dascal","sequence":"additional","affiliation":[{"name":"Universitatea Babes-Bolyai, Cluj-Napoca, Romania"},{"name":"Department of Public Health, Universitatea Babes-Bolyai, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Oni\u0219or","sequence":"additional","affiliation":[{"name":"Universitatea Babes-Bolyai, Cluj-Napoca, Romania"},{"name":"Department of Public Health, Universitatea Babes-Bolyai, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teodora","family":"Fr\u0103\u021bil\u0103","sequence":"additional","affiliation":[{"name":"Universitatea Babes-Bolyai, Cluj-Napoca, Romania"},{"name":"Department of Public Health, Universitatea Babes-Bolyai, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreea","family":"Morar","sequence":"additional","affiliation":[{"name":"Universitatea Babes-Bolyai, Cluj-Napoca, Romania"},{"name":"Department of Public Health, Universitatea Babes-Bolyai, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Mihu","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology Dominic Stanca Clinic, Universitatea de Medicina si Farmacie Iuliu Hatieganu, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristian I","family":"Iuhas","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology Dominic Stanca Clinic, Universitatea de Medicina si Farmacie Iuliu Hatieganu, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Caracostea","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Medicover Hospital, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Mure\u0219an","sequence":"additional","affiliation":[{"name":"Universitatea de Medicina si Farmacie Iuliu Hatieganu, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristie","family":"Foley","sequence":"additional","affiliation":[{"name":"Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Resnicow","sequence":"additional","affiliation":[{"name":"School of Public Health, University of Michigan, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristian I","family":"Meghea","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Biology, Michigan State University, East Lansing, Michigan, USA"},{"name":"Universitatea Babes-Bolyai, Cluj-Napoca, Romania"},{"name":"Department of Public Health, Universitatea Babes-Bolyai, Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,3,24]]},"reference":[{"key":"2025121223542662000_15.3.e100259.1","unstructured":"Institutul Na\u021bional de S\u0103n\u0103tate Public\u0103 . 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