- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01605643
Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women (MAW)
15. desember 2017 oppdatert av: Christi Patten, Mayo Clinic
Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women: Phase 1
Use of tobacco is very high among Alaska Native women.
The investigators are conducting a three phase study.
The first phase will examine biomarkers of tobacco exposure in pregnant women and their newborns.
The second phase is a qualitative study to translate the biomarker findings into intervention messages.
The third phase is a pilot of the biomarker feedback intervention compared with a control condition.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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 our successful partnership with the Alaska Native community and previous work with Alaska Native pregnant women.
We 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 we 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, we 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 80 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 our 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alaska
-
Anchorage, Alaska, Forente stater, 99577
- Alaska Native Tribal Health Consortium
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 50 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Pregnant women will be recruited through prenatal care
Beskrivelse
Inclusion Criteria:
To be eligible the woman must:
- be Alaska Native,
- be aged 18 years or older,
- provide written informed consent,
- be currently pregnant (1st, 2nd or 3rd trimester), and
- plan to deliver at the ANMC. An additional inclusion criterion for current tobacco users is any use in the past 7 days. Our preliminary studies indicate that women may use more than one form of tobacco. To enhance feasibility of recruitment and generalizability, women will not be excluded if they use more than one form of tobacco. Instead, group composition will be based on the primary type of tobacco used. An additional inclusion criterion for non-tobacco users is no use of any form of tobacco in the last 6 months.
Exclusion Criteria:
- Women will be excluded if they have used nicotine replacement therapy (NRT) or have participated in a behavioral or pharmacological tobacco cessation program within the past 30 days.
- Alcohol and other drug use will not be an exclusionary criterion because the biomarkers are specific to tobacco exposure.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
NNAL
Tidsramme: delivery
|
delivery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
cotinine
Tidsramme: participants will be followed during pregnancy until approximately week 40 gestation and Infants will be assessed at birth only
|
tobacco exposure measured during pregnancy and at delivery
|
participants will be followed during pregnancy until approximately week 40 gestation and Infants will be assessed at birth only
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christi A Patten, PhD, Mayo Clinic
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2012
Primær fullføring (Faktiske)
1. juni 2017
Studiet fullført (Faktiske)
1. desember 2017
Datoer for studieregistrering
Først innsendt
7. mai 2012
Først innsendt som oppfylte QC-kriteriene
23. mai 2012
Først lagt ut (Anslag)
25. mai 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. desember 2017
Sist bekreftet
1. desember 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 11-001144
- U54CA153605 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .