- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02431611
Biomarker Feedback to Motivate Cessation in Pregnancy (MAW Phase 3)
Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women (MAW) - Phase 3 Pilot Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Developing effective tobacco cessation interventions during pregnancy for American Indian and Alaska Native people is a national priority and will contribute to the U.S. public health objective of reducing tobacco-related cancer health disparities. The proposed project builds on the investigators' successful partnership with the Alaska Native community and previous work with Alaska Native pregnant women. The investigators propose to develop and test a novel biomarker feedback intervention relating cotinine levels in the urine of pregnant women with the woman and infant's likely exposure to the tobacco specific nitrosamine and carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be conducted in three phases. In Phase 1 the investigators will utilize a non-randomized, clinical observational trial to examine biomarkers of nicotine and carcinogen exposure (urine cotinine and total NNAL [a metabolite of NNK], respectively) among 150 maternal-infant pairs with assessments conducted during pregnancy and at delivery. In Phase 2, the investigators will obtain qualitative feedback on the findings from Phase 1 through individual interviews conducted with 32 women who use tobacco to develop the biomarker feedback intervention messages. Phase 3 will consist of a formative evaluation of the biomarker feedback intervention with 60 pregnant women using a two-group randomized design to assess the intervention's feasibility and acceptability, and the biochemically confirmed abstinence rate at the end of pregnancy. All phases of the project will be guided by a Community Advisory Committee. Each phase is an important step to advance the investigators' understanding of the potential for biomarker feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The potential reach of the intervention is significant from a public health perspective as over 600 tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where the proposed project will take place. Developing effective interventions for tobacco cessation during pregnancy is important to reduce adverse health consequences for the mother and neonate and future risk of tobacco-caused cancers.
This is the third and final phase of the project.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Alaska
-
Anchorage, Alaska, États-Unis, 99577
- Alaska Native Tribal Health Consortium
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Alaska Native
- 18 years or older
- provide written informed consent
- be currently pregnant and at <24 weeks gestation
- reside in Anchorage and plan to deliver at the ANMC
- current tobacco user defined as any use of Iqmik, commercial ST, and/or cigarettes during the past 7 days.
Exclusion Criteria:
- use of using nicotine replacement therapy or medications for tobacco cessation or participation in a behavioral cessation program within the past 30 days
- another woman from the same household has enrolled.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Control condition
Control behavioral phone-based smoking cessation intervention
|
phone-based behavioral smoking cessation counseling
|
|
Expérimental: Biomarker Feedback Intervention
Biomarker feedback plus behavioral phone-based smoking cessation intervention
|
Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine)
Délai: at week 36 gestation or greater up to the time of delivery
|
self-reported abstinence verified with cotinine
|
at week 36 gestation or greater up to the time of delivery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Self-efficacy (Self-reported confidence scale)
Délai: at week 36 gestation or greater up to the time of delivery
|
Self-reported confidence scale
|
at week 36 gestation or greater up to the time of delivery
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christi A Patten, PhD, Mayo Clinic
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 11-001144-02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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