Project CHOICES Efficacy Study
8. september 2005 opdateret af: Centers for Disease Control and Prevention
Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies
Project CHOICES Efficacy Study is a randomized controlled trial (RCT) designed to evaluate the clinical efficacy of a brief motivational intervention aimed at reducing alcohol-exposed pregnancies(AEP)in high-risk preconceptional women.
The study is a multi-site collaborative study between the CDC and three universities.
The hypothesis of the study is that a greater proportion of women will reduce thier risk of having an alcohol-exposed pregnancy after participating in the Information Plus Counseling (IPC) intervention than do those in the Information Only(IO) control group.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Women at high risk for an AEP are define as sexually active, fertile women who are drinking more than 7 drinks per week and/or 5 or more drinks on any one day, and are noy using effective measures to prevent pregnancy.
Participants will be recruited from community-based setting previously shown to have increased proportions of women at risk for AEP.
Women in the intervention group (IPC) will receive 4 counselling sessions that include personal feedback on AEP risk behaviors drawn from baseline information,consequences of alcohol use in pregnancy, assessing readiness to change risk behaviors, pros and cons of risk drinking and unprotected intercourse, goal setting to reduce risk behaviors, and a consultation visit with a family planning provider to discuss appropriate choices for pregnancy prevention based on clinical assessment.
Clients are counseled that there are two routes to reducing AEP risk, alcohol reduction or pregnancy prevention, with the ideal being both.
Women in the control group (IO) will receive an informational brochure that addresses healthy lifestyle behaviors, including alcohol use, and a list of referral sources for health care treatment and alcohol abuse treatment.
Both groups will be assessed at baseline using a full battery of measures that include alcohol and contraceptive use with follow-up measures at 3, 6, and 9 months after baseline.
Undersøgelsestype
Interventionel
Tilmelding
1200
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Florida
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Ft. Lauderdale, Florida, Forenede Stater, 33314
- Broward County Health District Primary Care Centers
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Ft. Lauderdale, Florida, Forenede Stater, 33314
- Media Recruited Participants from Broward County
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Texas
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Dayton, Texas, Forenede Stater, 77030
- Plane State Jail
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Houston, Texas, Forenede Stater, 77030
- Career and Recovery
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Houston, Texas, Forenede Stater, 77030
- Door to Recovery
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Houston, Texas, Forenede Stater, 77030
- Harris County Jail
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Houston, Texas, Forenede Stater, 77030
- Houston Recovery Campus
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Houston, Texas, Forenede Stater, 77030
- New Directions
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Houston, Texas, Forenede Stater, 77030
- Sally's House
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Virginia
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Richmond, Virginia, Forenede Stater, 23298
- Medicaid Helath Maintenance Organization
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Richmond, Virginia, Forenede Stater, 23298
- Outpatient Gynecology Clinic-Virginia Commonwealth Univ
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 44 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria: Women who: are not pregnant, are between the ages of 18 and 44 years, consume more than seven drinks per week and/or at least one binge episode (five or more drinks in one day) in the last 90 days (for the Texas jail & recovery center sites, this will be the 90 days before entering these facilities), are able to provide and do provide informed consent, are members of the special setting's population, and are available for follow-up through 9 months after recruitment.
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Exclusion Criteria: Women who: do not meet the inclusion criteria, cannot commit to provide information about how to be contacted for follow-up, or are unable to understand spoken English.
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.
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Sekundære resultatmål
Resultatmål |
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Mediators and moderators of reduced risk in the IPC and IO groups.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Rosa L Floyd, DSN, Centers for Disease Control and Prevention
- Ledende efterforsker: Mark B Sobell, PhD, Nova Southeastern University
- Ledende efterforsker: Mary V. Velasquez, PhD, The University of Texas Health Science Center, Houston
- Ledende efterforsker: Karen Ingersol, PhD, Virginia Commonwealth University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2002
Studieafslutning
1. august 2004
Datoer for studieregistrering
Først indsendt
8. september 2005
Først indsendt, der opfyldte QC-kriterier
8. september 2005
Først opslået (Skøn)
12. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. september 2005
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2005
Sidst verificeret
1. september 2005
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDC-NCBDDD-3271
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .