- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00379925
Effectiveness of a Church-Based Program at Increasing Physical Activity and Healthy Dietary Habits in African Americans
A Partnership to Promote Physical Activity and Healthy Eating in AME Churches
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Many obesity-related diseases, including diabetes, cancer, and heart disease, occur more frequently in ethnic minorities than in Caucasians. African Americans have an extremely high church attendance rate, making church-based interventions a viable method to reach a wide audience and positively influence health habits and behaviors. The most effective way to prevent or reverse the effects of obesity is through weight loss, which can be accomplished by increasing physical activity and following a low fat and low sodium diet that emphasizes fruits, vegetables, and whole grains. Few programs have been developed that have specifically examined the effects of a church-based physical activity and dietary intervention. This study will encourage church leaders to assist in the development of a health promotion program that will incorporate the church's social, cultural, and policy influences. The purpose of the study is to evaluate the effectiveness of the intervention on increasing physical activity, improving blood pressure levels, and promoting healthy dietary habits among church members. The importance of pastor support and participation will be evaluated, and the results from this study may be used to develop additional church-based interventions across a larger geographic area.
In Year 1 of this 5-year study, representatives from the Palmetto Conference of the African Methodist Episcopal (AME) Church and three state universities in South Carolina will participate in monthly planning sessions to develop the intervention. Local health committees and church pastors and cooks will be trained to implement the program. The 18-month intervention will occur in three waves; where at least 60 churches will be randomly assigned to participate in either the immediate intervention or delayed intervention. The program will emphasize increased physical activity and the adaptation of a healthy diet that includes low fat and low sodium foods, fruits, vegetables, and whole grains. At baseline and Month 18, blood pressure will be measured, and physical activity levels and fruit and vegetable intake will be assessed for some church members. Additionally, throughout the study, some participants will wear an accelerometer, which is a small device that measures physical activity levels.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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South Carolina
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Lane, South Carolina, Forente stater, 29564
- African Methodist Episcopal Churches in South Carolina
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Member of a church in the Palmetto Conference of the 7th Episcopal District of the AME Church
- Attends church services or events at least once per month
Exclusion Criteria:
- Planning to move in the 18 months following study entry
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Behavioral
Participants will take part in the Physical Activity and Dietary Health Promotion Program.
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Churches within the intervention group will receive a committee training and church cook training designed to teach them how to do a self-assessment of current practices and develop a plan for their program.
The intervention is based on the structural model of health behavior and targets opportunities, mass media (within the church), guidelines and policies, and church environment.
Intervention churches also receive monthly intervention mailings to support intervention implementation.
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Ingen inngripen: Delayed intervention
Participants are assigned to a delayed intervention group and serve as a no-intervention control group.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Blood pressure
Tidsramme: 15 months
|
Systolic and diastolic blood pressure
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15 months
|
Physical activity (measured with the Community Healthy Activities Model Program For Seniors [CHAMPS] questionnaire)
Tidsramme: 15 months
|
Self-report measure of physical activity
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15 months
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Fruit and vegetable consumption (measured with NCI screener & 2-item measure)
Tidsramme: 15 months
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self-report measure of physical activity
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15 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Physical activity (measured with an accelerometer)
Tidsramme: 15 months
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Accelerometer measured physical activity
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15 months
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Fat consumption
Tidsramme: 15 months
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Self-reported measure of practices associated with fat consumption
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15 months
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Fiber consumption
Tidsramme: 15 months
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Self-reported measure of practices associated with fiberconsumption
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15 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sara Wilcox, PhD, University of South Carolina
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kyryliuk R, Baruth M, Wilcox S. Predictors of Weight Loss for African-American Women in the Faith, Activity, and Nutrition (FAN) Study. J Phys Act Health. 2015 May;12(5):659-65. doi: 10.1123/jpah.2013-0220. Epub 2014 Jun 4.
- Saunders RP, Wilcox S, Baruth M, Dowda M. Process evaluation methods, implementation fidelity results and relationship to physical activity and healthy eating in the Faith, Activity, and Nutrition (FAN) study. Eval Program Plann. 2014 Apr;43:93-102. doi: 10.1016/j.evalprogplan.2013.11.003. Epub 2013 Dec 10.
- Wilcox S, Parrott A, Baruth M, Laken M, Condrasky M, Saunders R, Dowda M, Evans R, Addy C, Warren TY, Kinnard D, Zimmerman L. The Faith, Activity, and Nutrition program: a randomized controlled trial in African-American churches. Am J Prev Med. 2013 Feb;44(2):122-31. doi: 10.1016/j.amepre.2012.09.062. Erratum In: Am J Prev Med. 2013 Jun;44(6):694-5.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Pro00005414
- R01HL083858 (U.S. NIH-stipend/kontrakt)
- R01HL083858-01 (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. .
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