Lifestyle Change to Prevent Diabetes Via African-American Churches
NCT ID: NCT01730196
Last Updated: 2014-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
604 participants
INTERVENTIONAL
2009-09-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Fit Body and Soul
Faith-based adaptation of the Group Life Style Program
Fit Body and Soul
Wellness education
A health education program developed from the list of topics provided by the Centers for Disease Control and Prevention (CDC) Guide to Community Prevention Services
Wellness Education
Interventions
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Fit Body and Soul
Wellness Education
Eligibility Criteria
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Inclusion Criteria
* BMI ≥25kg/m2
* Planning to remain within the community for 1 year
* Non-diabetic
Exclusion Criteria
* HIV/AIDS
* Active tuberculosis
* Cancer requiring treatment in past 5 years except for cancers that have been cured or in the opinion of the researchers has a good prognosis
* Stroke within the past 6 months
* Cirrhosis of the liver
* Currently pregnant or planning pregnancy within the study period
* Gastric weight-loss surgery
* Weight loss \> 10% in past three months for any reason other than childbirth
* Anti-diabetic medications
* Prescription weight- loss medications
* Anti-neoplastic agents
* Anti-psychotic agents that have gluco-corticoid effect
* Oral corticosteroid use \>6 weeks
* Unwilling or unable to give informed consent
* Unable to communicate with the church team or research group
* Participation in another research study that would interfere with FBAS
20 Years
64 Years
ALL
Yes
Sponsors
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Augusta University
OTHER
Responsible Party
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Richard Sattin
Professor and Research Director, Department of Emergency Medicine
Principal Investigators
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Richard W Sattin, MD
Role: PRINCIPAL_INVESTIGATOR
Augusta University
Locations
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Georgia Health Sciences University
Augusta, Georgia, United States
Countries
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References
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Rhodes EC, Chandrasekar EK, Patel SA, Narayan KMV, Joshua TV, Williams LB, Marion L, Ali MK. Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis. Diabetes Res Clin Pract. 2018 Dec;146:85-92. doi: 10.1016/j.diabres.2018.09.016. Epub 2018 Sep 28.
Sattin RW, Williams LB, Dias J, Garvin JT, Marion L, Joshua TV, Kriska A, Kramer MK, Narayan KM. Community Trial of a Faith-Based Lifestyle Intervention to Prevent Diabetes Among African-Americans. J Community Health. 2016 Feb;41(1):87-96. doi: 10.1007/s10900-015-0071-8.
Other Identifiers
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