Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of
the GLB program compared with a health education intervention.
Behavioral: Fit Body and Soul
Behavioral: Wellness Education
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Full eligibility criteria for NCT01730196
Ages eligible for Study
20 Years to 64 Years
Genders eligible for Study
Accepts Healthy Volunteers
Self-described African American
Planning to remain within the community for 1 year
Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%
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
Prescription weight- loss medications
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
All locations for NCT01730196
United States (1)
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
View full eligibility
Tris trial is registered with FDA with number: NCT01730196. The sponsor of the trial is Augusta University and it is looking for 604 volunteers for the current phase.
Official trial title: Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches
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