- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02121691
Faith-Based Initiative to Promote Health in Appalachia
Appalachia Community Cancer Network II Centers for Reducing Cancer Disparities: Faith-Based Initiative to Promote Health in Appalachia
The project will target two behavioral causes of obesity: a sedentary lifestyle and an unhealthy diet. The goal is to test a faith-based intervention among men and women who are members of participating Appalachian churches.
The primary hypothesis being tested in this project is: The change in body mass index from baseline to one year follow-up in intervention churches will be greater than among comparison churches, such that the differential change will be negative on average.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- Markey Cancer Center
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-
Ohio
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
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Pennsylvania
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University Park, Pennsylvania, Forenede Stater, 16802
- Penn State University
-
-
Virginia
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Blacksburg, Virginia, Forenede Stater, 24061
- Virginia Tech
-
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18 or older
- Member of the participating church who has attended services at least 4 times in the past 2 months
- resident of an Appalachia county
- Able bodied (no contraindications to physical activity and no dietary restrictions that are part of a medically prescribed diet for weight loss or formal weight loss program)
- Able to read and write in English
- Have a BMI indicating that they are overweight (BMI > or = 25.0, assessed during biometric measurement)
- Under 400 pounds (per self-report and confirmed during biometric measurement)
- Not planning to move out of the area within the next year
- Does not reside in nursing facility or residential home
- If female, is not pregnant, breastfeeding or less than 9 months post-partum and does not intend to become pregnant during the study
- Able to provide informed consent.
Exclusion Criteria:
- Does not meet Inclusion criteria
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Walk by Faith
Intervention arm
|
The Walk by Faith program is aimed at increasing physical activity and improving healthy eating to reduce or maintain healthy BMI among members of the churches.
|
|
Ingen indgriben: Comparison
Non-intervention arm
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in body mass index from baseline to one year follow-up
Tidsramme: Baseline, month 12
|
Baseline, month 12
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mark Dignan, PhD, MPH, Lucille P. Markey Cancer Center at University of Kentucky
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012-085
- NCI-2013-01400 (Anden identifikator: NCI CTRP)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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Kliniske forsøg med Walk by Faith
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University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)RekrutteringDepressionForenede Stater
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University of California, San FranciscoUniversity of California, BerkeleyAfsluttet
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Emory UniversityNational Institute on Aging (NIA)Afsluttet
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Oregon Research InstituteAfsluttetTobaksrygning | SundhedsfremmeForenede Stater
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Izmir Democracy UniversityIkke rekrutterer endnu
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Vilnius UniversityAfsluttetSund og rask | Stress | Angst | Psykisk nød | Trivsel | Mentalt helbred | Depressionslidelser | Kropsbevidsthed | VitalityLitauen
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Gazi UniversityAfsluttet
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NYU Langone HealthAfsluttetMentalt helbredForenede Stater
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Wake Forest University Health SciencesNational Council on Aging (NCOA)RekrutteringForebyggelse af faldForenede Stater
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Arizona State UniversityNational Heart, Lung, and Blood Institute (NHLBI)RekrutteringHjertesygdomme | Diabetes mellitus | Fysisk aktivitet | Dyrke motion | Fysisk inaktivitetForenede Stater