Lifestyle Change to Prevent Diabetes Via African-American Churches
Completed · Not applicable
Conditions studied: Diabetes, Weight Loss
In brief
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.
Key facts
- Study ID
- NCT01730196
- Run by
- Augusta University
- People needed
- 604
- Starts
- 2009-09-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2014-04-09
Who can join
Age: 20 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Self-described African American
- BMI ≥25kg/m2
- Planning to remain within the community for 1 year
- Non-diabetic
You may not qualify if…
- Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%
- 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
Where it is running
- Georgia Health Sciences University — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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