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Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes - NCT01004848-10029(Clinical Trial 385940)



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City:  New York
State:  
NY
Zip Code: 10029
Conditions: Pre-diabetes
Purpose: The purpose of this study is to compare the effectiveness of a peer-led community-based lifestyle intervention, versus usual care, in achieving weight loss and prevention of diabetes among overweight adults with pre-diabetes in East Harlem.
Study summary: Weight loss can prevent diabetes and eliminate racial and ethnic disparities in incident diabetes among overweight adults with pre-diabetes. However, proven effective interventions have not been sustained or disseminated in community settings. A community-academic partnership aims to employ community-based participatory research to conduct a randomized controlled trial to test the effectiveness of a culturally tailored, peer-led diabetes prevention intervention that promotes weight loss. People who develop diabetes go through a period when they have "pre-diabetes". In clinical settings, overweight adults with pre-diabetes who reduce their weight by 5-10% can reduce their risk of developing diabetes by 55-60%. To date, there are no studies testing the effectiveness of peer-led, community-based programs in achieving diabetes prevention through weight loss. We will identify and enroll 400 overweight (BMI > 25) adults with pre-diabetes in East Harlem and randomized half into a community-based, peer-led lifestyle education program that teaches simple ways to lose weight.
Criteria: Inclusion Criteria: - 18 years of age and older - Residents of East Harlem with a permanent residence in zip codes 10029, 10035, OR in the section of 10037 east of Fifth Avenue - BMI ≥ 25 AND pre-diabetes glucose values, defined as fasting fingerstick glucose of 100-125mg/dl and/or glucose 2 hours after an oral glucose load of 140-199 mg/dl - Able to communicate verbally to participate in a group education class - English or Spanish speaking Exclusion Criteria: - < 18 years - Previous diagnosis of diabetes - BMI <25 - Fingerstick glucoses outside pre-diabetes level ranges - Currently pregnant - On medications that may raise or lower blood glucose - Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak) - Self-reported terminal illness with life expectancy of less than 1 year - Plans to relocate from New York City within one year of enrollment
Study is available at: Mount Sinai School of Medicine
New York, NY 10029
United States

Primary Contact:
Carol R Horowitz, MD, MPH
Email: carol.horowitz@mountsinai.org
Phone: 212-659-9567

Secondary Contact:
Carol R Horowitz, MD, MPH
Email: carol.horowitz@mountsinai.org
Phone: 212-659-9567
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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