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Smartphone-based Incentives Intervention to Increase Smoking Cessation During Pregnancy

20 settembre 2026 aggiornato da: Stephen T. Higgins, PhD, University of Vermont

Examining a Digital Perinatal Smoking-Cessation Intervention

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

137

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Vermont
      • Burlington, Vermont, Stati Uniti, 05464
        • University of Vermont

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • 18 yrs of age
  • Reports current pregnancy of </= 25 weeks gestational age
  • Consents to allow us to confirm pregnancy with healthcare provider
  • Reports current smoking when learned of current pregnancy
  • Reports smoking in the 7 days prior to screening
  • Reports of smoking in past 7 days is confirmed by a salivary cotinine test
  • Owns a digital phone or tablet
  • Sufficiently fluent in English to complete study tasks

Exclusion Criteria:

  • Reports current or prior mental or medical condition that may interfere with study participation
  • Reports current opioid agonist treatment for opioid use disorder
  • Current use of prescribed opioid, antipsychotic, or stimulant medications
  • Live with someone who is enrolled in the study
  • Reside in a group home
  • Currently participating in another study that provides financial incentives
  • Legal problems that may result in incarceration within the next year

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Best Practices

Best Practices (BP) entails the 5As including referral to the state tobacco Quitline and further referral for those continuing to smoke.
Comportamentale: Best Practices

Participants receive the 5As including a staff referral to the state tobacco quitline.
Sperimentale: 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.
Comportamentale: Best Practices

Participants receive the 5As including a staff referral to the state tobacco quitline.

Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Antepartum smoking abstinence
Lasso di tempo: Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.

The primary outcome is whether women randomly assigned to the two treatment groups differ in the percentage who abstain from smoking across an early (< 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postpartum smoking abstinence
Lasso di tempo: 2-weeks, 6-weeks, 12-weeks following delivery.

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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Birth Outcomes
Lasso di tempo: Birth record at time of delivery

Birth outcomes calculated from data extracted from the birth delivery reports include mean birth weight, % low birth weight deliveries (< 2500 g), mean gestational age at delivery, % premature deliveries (< 37 weeks), incidence of Neonatal Intensive Care Unit (NICU) admissions, and mean length of stay per NICU admission.
Birth record at time of delivery
Treatment Acceptability Questionnaire
Lasso di tempo: 24 weeks following delivery

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
Smoking abstinence at 24-weeks postpartum
Lasso di tempo: 24 weeks after delivery

Participants report no smoking in the past 7 days that is confirmed with a negative salivary cotinine test
24 weeks after delivery
Cost effectiveness
Lasso di tempo: 24-weeks postpartum

A cost-effectiveness analysis of adding financial incentives to the Best-Practices intervention will be conducted.
24-weeks postpartum

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Vermont

Collaboratori

National Institute on Drug Abuse (NIDA)
DynamiCare Health

Investigatori

  • Investigatore principale: Stephen T Higgins, PhD, University of Vermont

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

27 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 settembre 2026

Primo Inserito (Effettivo)

24 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00004146
  • UG3DA065232 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Investigators are willing to share data once the study is completed and results are published in a peer-reviewed journal. Sharing is conditional on those requesting having a scientific rationale for their request.

Periodo di condivisione IPD

Upon study completion and publication of the primary trial outcomes in a peer-reviewed journal and planned secondary outcomes (e.g., birth outcomes, cost-effectiveness). Anticipated start date is 3 years after trial completion. Anticipated end date is 5 years after study completion.

Criteri di accesso alla condivisione IPD

Briefly, this trial will use the standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR). All shared data, metadata, and associated documentation will be deposited via the National Addiction & HIV Data Archive Program (NAHDAP), which is hosted by ICPSR. The scientific data provided by our trial will be findable via a study digital object identifier (DOI) minted by ICPSR. Users of our shared scientific data must register with ICPSR and agree to the Terms of Use, which allows use only for scientific research purposes and aggregate statistical analyses. This is intended to protect research participants and prohibit attempts to identify individual participants. Users must also agree to not redistribute data downloads.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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