- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00139529
Education and Counseling for Abstinence From Tobacco After Pregnancy
Postpartum Maintenance of Abstinence From Tobacco
Przegląd badań
Status
Warunki
Szczegółowy opis
BACKGROUND:
Pregnancy is an ideal time to help underserved young women to stop smoking cigarettes and remain abstinent for life. The field has made great progress in assisting women to quit during this time. Unfortunately, maintenance of this highly significant behavior change is dismal. Up to 75% of those who quit for pregnancy end up returning to smoking after delivery of the newborn. For underserved women, pregnancy is one of the few times that they have an extended contact with the health care system. Therefore, there is an opportunity to help these women quit smoking for the health of their fetus in addition to their own health. To date, there has been insufficient research on how best to maintain abstinence during the critical postpartum period, during which a unique constellation of risk factors (including sleep deprivation, variations in negative mood, and increased stress) heighten the probability of relapse. The potential payoff is enormous. The literature, while not extensive, provides sufficient guidance and justification for the specific approach and intervention components the study has chosen.
DESIGN NARRATIVE:
This study will develop and field test a maintenance of smoking abstinence program to be designed for a predominately low-income, high-risk population of women from a wide variety of ethnic and racial backgrounds who have quit smoking because of (or during) their pregnancy. The study will compare biologically confirmed postpartum smoking relapse rates of women who receive an educational intervention during pregnancy combined with sustained telephone counseling after that intervention, with women who receive only an educational intervention. Participants will begin at 28 weeks prenatal and will be followed through 1, 3, 6, and 12 months postpartum.
The specific aims of the current maintenance study are: 1) to compare biochemically confirmed smoking abstinence rates of women who quit smoking during their pregnancy and who receive an intervention based on telephone counseling using motivational interviewing versus quitters who receive usual care, maintenance of abstinence will be assessed at 1, 3, 6, and 12 months postpartum; and 2) to collect both qualitative and quantitative data to better understand short term and long term maintenance mediators and moderators of abstinence postpartum for women of low socioeconomic status (SES) who quit smoking during pregnancy.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02903
- Brown University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Smoked tobacco immediately before pregnancy
Exclusion Criteria:
- Smoked tobacco in the previous 7 days when contacted at 28 weeks gestation
- No telephone access
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 1
Participants will receive an educational intervention during pregnancy combined with a motivational interviewing program using telephone counseling to prevent postpartum relapse to tobacco use.
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Participants will receive up to 5 phone calls.
Educational intervention will be completed during pregnancy.
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Aktywny komparator: 2
Participants will receive an educational intervention during pregnancy.
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Educational intervention will be completed during pregnancy.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Smoking status
Ramy czasowe: Measured at 1, 3, 6, and 12 months postpartum
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Measured at 1, 3, 6, and 12 months postpartum
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ETS exposure
Ramy czasowe: Measured at 1, 3, 6, and 12 months postpartum
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Measured at 1, 3, 6, and 12 months postpartum
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Urine cotinine analyses
Ramy czasowe: Measured at 1, 3, 6, and 12 months postpartum
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Measured at 1, 3, 6, and 12 months postpartum
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Patricia M. Risica, DrPH, Brown University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 248
- R01HL077608 (Grant/umowa NIH USA)
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