[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657531":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":43,"studyPopulation":40,"armGroups":44,"interventions":56,"overallOfficials":65,"centralContacts":69,"locations":77,"responsibleParty":90,"collaborators":93,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":40,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":40,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":128,"whyStopped":40,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"University of Vermont","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Antepartum smoking abstinence","The primary outcome is whether women randomly assigned to the two treatment groups differ in the percentage who abstain from smoking across an early (\\\u003C 25 weeks gestation) and late (\\> 25 weeks gestation) antepartum assessments defined by the percentage of participants assigned to each condition who report no smoking in the past 7 days and submit of a salivary cotinine sample that tests negative for recent smoking.","Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.",[14],{"measure":15,"description":16,"timeFrame":17},"Postpartum smoking abstinence","Smoking abstinence at 2, 6, and 12 weeks postpartum defined as the percent of participants randomly assigned to each of the two treatment conditions who report no smoking in the past 7 days and submit of a salivary cotinine test sample that is negative for recent smoking.","2-weeks, 6-weeks, 12-weeks following delivery.",[19,23,27,31],{"measure":20,"description":21,"timeFrame":22},"Birth Outcomes","Birth outcomes calculated from data extracted from the birth delivery reports include mean birth weight, % low birth weight deliveries (\\\u003C 2500 g), mean gestational age at delivery, % premature deliveries (\\\u003C 37 weeks), incidence of Neonatal Intensive Care Unit (NICU) admissions, and mean length of stay per NICU admission.","Birth record at time of delivery",{"measure":24,"description":25,"timeFrame":26},"Treatment Acceptability Questionnaire","Participants in both treatment conditions will complete the Treatment Acceptance Questionnaire (TAQ) at the 24-weeks postpartum assessment. The TAQ will query participants about the (1) ease of use of their assigned intervention; (2) helpfulness, and (3) convenience of the intervention; (4) whether the intervention facilitated engagement with smoking-cessation treatment; (5) whether the intervention was fair, (6) fun, (7) or helpful in abstaining from smoking during pregnancy, (8) after the baby was born, and (9) longer-term; and (10) whether they would recommend the treatment that they received to others. All responses will be made using a 100-point visual analogue scale with higher scores represent greater acceptance.","24 weeks following delivery",{"measure":28,"description":29,"timeFrame":30},"Smoking abstinence at 24-weeks postpartum","Participants report no smoking in the past 7 days that is confirmed with a negative salivary cotinine test","24 weeks after delivery",{"measure":32,"description":33,"timeFrame":34},"Cost effectiveness","A cost-effectiveness analysis of adding financial incentives to the Best-Practices intervention will be conducted.","24-weeks postpartum",{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":40,"timePerspective":40,"maskingInfo":41},"RANDOMIZED","PARALLEL","The design is a two parallel groups randomized clinical trial to assess if combining financial incentives with Best Practices improves outcomes above treatment with Best Practices alone.","TREATMENT",null,{"masking":42,"maskingDescription":40,"whoMasked":40},"NONE","Pregnant women residing in the U.S. who currently smoke cigarettes and are interested in quitting will be recruited nationally and randomly assigned to what is considered clinical best practices (BP) (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) or best practices in combination with financial incentives (BP+FI). Women assigned to the BP+FI treatment will have opportunities to earn financial incentives by abstaining from smoking during pregnancy and for 3 months after delivering their baby (total possible incentives is $750.00). Women will demonstrate that they have abstained by taking brief salivary cotinine tests using a smartphone or equivalent device. Incentives for abstaining are electronically added to a study-provided debit card. Participation and all results are strictly confidential. Participants in both treatment conditions will be financially compensated for study participation with potential earnings of $525.00. Total potential earnings for those assigned to BP is $525.00 and for those assigned to BP+FI it is $1,275 ($525 for study participation and $750 in incentives for quitting smoking).",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Best Practices","EXPERIMENTAL","Best Practices (BP) entails the 5As including referral to the state tobacco Quitline and further referral for those continuing to smoke.",[50],"Behavioral: Best Practices",{"label":52,"type":47,"description":53,"interventionNames":54},"Best Practices plus Financial Incentives","Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.",[50,55],"Behavioral: Financial Incentives",[57,61],{"type":58,"name":46,"description":59,"armGroupLabels":60,"otherNames":40},"BEHAVIORAL","Participants receive the 5As including a staff referral to the state tobacco quitline.",[46,52],{"type":58,"name":62,"description":63,"armGroupLabels":64,"otherNames":40},"Financial Incentives","Participants receive financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.",[52],[66],{"name":67,"affiliation":5,"role":68},"Stephen T Higgins, PhD","PRINCIPAL_INVESTIGATOR",[70,74],{"name":67,"role":71,"phone":72,"phoneExt":40,"email":73},"CONTACT","802-656-9615","stephen.higgins@uvm.edu",{"name":75,"role":71,"phone":72,"phoneExt":40,"email":76},"Katya A Nolder, PhD","katya.nolder@uvm.edu",[78],{"facility":5,"status":40,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":40},"Burlington","Vermont","05464","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-73.21207,44.47588,{"lat":88,"lon":87},{"type":68,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Stephen T. Higgins, PhD","University Distinguished Professor",[94,97],{"name":95,"class":96},"DynamiCare Health","INDUSTRY",{"name":98,"class":99},"National Institute on Drug Abuse (NIDA)","NIH","100657531","smartphone-based-incentives-intervention-to-increase-smoking-cessation-during-pregnancy-100657531",false,"NCT07840118","Smartphone-based Incentives Intervention to Increase Smoking Cessation During Pregnancy","Examining a Digital Perinatal Smoking-Cessation Intervention","Inclusion Criteria:\n\n* 18 yrs of age\n* Reports current pregnancy of \\\u003C\u002F= 25 weeks gestational age\n* Consents to allow us to confirm pregnancy with healthcare provider\n* Reports current smoking when learned of current pregnancy\n* Reports smoking in the 7 days prior to screening\n* Reports of smoking in past 7 days is confirmed by a salivary cotinine test\n* Owns a digital phone or tablet\n* Sufficiently fluent in English to complete study tasks\n\nExclusion Criteria:\n\n* Reports current or prior mental or medical condition that may interfere with study participation\n* Reports current opioid agonist treatment for opioid use disorder\n* Current use of prescribed opioid, antipsychotic, or stimulant medications\n* Live with someone who is enrolled in the study\n* Reside in a group home\n* Currently participating in another study that provides financial incentives\n* Legal problems that may result in incarceration within the next year","FEMALE","18 Years","50 Years",{"count":111,"type":112},137,"ESTIMATED","INTERVENTIONAL",[115],"NA","Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S. and a problem for which more effective and easy-to-access treatments are much needed. This study examines whether outcomes achieved with recommended clinical practices (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) can be improved by also offering financial incentives delivered through a smartphone for maternal smoking abstinence.",[118,119],"Smoking During Pregnancy and Postpartum","Perinatal Cigarette Smoking",[121,122,123,124,125,126,127],"cigarettes","smoking","smoking cessation","pregnancy","postpartum","women","financial incentives","NOT_YET_RECRUITING","2026-09-20",{"date":131,"type":132},"2026-09-24","ACTUAL",{"date":134,"type":112},"2026-09",{"date":136,"type":112},"2028-05",{"name":5,"class":6},1]