- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01120041
Community-based Intergenerational Oral Health Study (Baby Smiles)
10. januar 2011 opdateret af: University of Washington
Community-based Intergenerational Oral Health Promotion In Rural America
The purpose of this study is to determine whether giving brief motivational interviewing counseling during the prenatal and/or postnatal period(s) will increase utilization of preventive dental care and improve the oral health of rural, low-income pregnant and postpartum women and their children, and to increase the number of home oral health practices taken by these women to prevent caries in their young children.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
400
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Oregon
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Grants Pass, Oregon, Forenede Stater, 97526
- Rekruttering
- Josephine County Public Health Department
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Madras, Oregon, Forenede Stater, 97741
- Rekruttering
- Jefferson County Public Health Department
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Newport, Oregon, Forenede Stater, 97365
- Rekruttering
- Lincoln County Human Services Department
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Roseburg, Oregon, Forenede Stater, 97470-3093
- Rekruttering
- Douglas County Health & Social Services
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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
15 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Pregnant (week 26 or earlier)
- At least 15 years of age
- Medicaid eligible
- Speaks English
- Willing and able to comply with study instructions
- Mother AND child available for length of the study (~ 24 months)
Exclusion Criteria:
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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: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Prenatal MI - Postpartum MI
Motivational interviewing counseling given during the prenatal and postpartum phases
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Motivational interviewing counseling given during the prenatal and postpartum phases
Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
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Eksperimentel: Prenatal MI - Postpartum Health Ed
Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
|
Motivational interviewing counseling given during the prenatal and postpartum phases
Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
|
|
Eksperimentel: Prenatal Health Ed - Postpartum MI
Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
|
Motivational interviewing counseling given during the prenatal and postpartum phases
Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
|
|
Placebo komparator: Prenatal Health Ed/Postpartum Health Ed
Traditional health education given during the prenatal phase and the postpartum phase
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Traditional health education given during the prenatal phase and the postpartum phase
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Visiting the dentist during pregnancy and up to two months postpartum for the mother and visiting the dentist before 18 months for the child.
Tidsramme: During pregnancy and up to two months post partum (mother); up to 18 months (child)
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During pregnancy and up to two months post partum (mother); up to 18 months (child)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christine A Riedy, PhD, MPH, University of Washington
- Ledende efterforsker: Philip Weinstein, PhD, University of Washington
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Riedy CA, Weinstein P, Mancl L, Garson G, Huebner CE, Milgrom P, Grembowski D, Shepherd-Banigan M, Smolen D, Sutherland M. Dental attendance among low-income women and their children following a brief motivational counseling intervention: A community randomized trial. Soc Sci Med. 2015 Nov;144:9-18. doi: 10.1016/j.socscimed.2015.09.005. Epub 2015 Sep 8.
- Weinstein P, Milgrom P, Riedy CA, Mancl LA, Garson G, Huebner CE, Smolen D, Sutherland M, Nykamp A. Treatment fidelity of brief motivational interviewing and health education in a randomized clinical trial to promote dental attendance of low-income mothers and children: Community-Based Intergenerational Oral Health Study "Baby Smiles". BMC Oral Health. 2014 Feb 24;14:15. doi: 10.1186/1472-6831-14-15.
- Milgrom P, Riedy CA, Weinstein P, Mancl LA, Garson G, Huebner CE, Smolen D, Sutherland M. Design of a community-based intergenerational oral health study: "Baby Smiles". BMC Oral Health. 2013 Aug 6;13:38. doi: 10.1186/1472-6831-13-38.
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. maj 2010
Primær færdiggørelse (Forventet)
1. maj 2013
Studieafslutning (Forventet)
1. maj 2013
Datoer for studieregistrering
Først indsendt
6. maj 2010
Først indsendt, der opfyldte QC-kriterier
6. maj 2010
Først opslået (Skøn)
10. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. januar 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. januar 2011
Sidst verificeret
1. januar 2011
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 37124-C
- 5U54DE019346 (U.S. NIH-bevilling/kontrakt)
- 09-016E
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 .
Kliniske forsøg med Forebyggende sundhedstjenester
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Shanghai Mental Health CenterRekrutteringMental Health LiteracyKina
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Fonterra Research CentreSun GenomicsAfsluttet
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City University of Hong KongStanford University; Harvard UniversityAfsluttetMental Health WellnessColombia, Indonesien, Sydafrika, Ukraine
Kliniske forsøg med motivational interviewing counseling
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Wright State UniversityPremier HealthIkke rekrutterer endnuUdbrændthed, professionel | Patientengagement | Motiverende samtale | Flere kroniske tilstande | Implicit biasForenede Stater
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Universiti Sains MalaysiaIkke rekrutterer endnuSunde kvinder | Caries af spædbørn
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Northwell HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetAlkohol drikke | Alkoholisme | Alkohol-relaterede lidelser | Alkoholbrugsforstyrrelser | Alkohol misbrugForenede Stater
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University of VermontAfrica Mental Health FoundationAfsluttetAlkoholbrugsforstyrrelse
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University of MiamiAB InBev FoundationAfsluttet
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Florida State UniversityJohns Hopkins University; Children's Hospital of Philadelphia; University... og andre samarbejdspartnereAfsluttetHIV-infektioner | Ungdomsudvikling | Plejefremkaldende adfærd | Patient manglende overholdelse | Patient afslag på behandlingForenede Stater
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University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbejdspartnereAktiv, ikke rekrutterende
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Northwestern UniversityGeorgetown UniversityAfsluttetKroniske nyresygdomme | Genetisk dispositionForenede Stater
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Texas Christian UniversityAfsluttetMapping Enhanced Counseling (MEC) | Active Linkage (AL)Forenede Stater
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Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RekrutteringAlkohol drikke | Hiv | Efterår | Brug af cannabisForenede Stater