Collaborations for Health Improvement in East Harlem-Project HEED
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-diabetes
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 402
- Locations
- 1
- Primary Endpoint
- Change in Weight From Baseline to 6 Months
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age and older
- •Residents of East Harlem or members of an East Harlem Institution 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
- •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
Outcomes
Primary Outcomes
Change in Weight From Baseline to 6 Months
Time Frame: Change from Baseline to 6 Months
Secondary Outcomes
- HDL Cholesterol(Change from Baseline to 6 Months)
- Total Cholesterol(Change from Baseline to 6 Months)
- Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months(Change from Baseline to 6 Months)
- Change in Systolic Blood Pressure From Baseline to 6 Months(Change from Baseline to 6 Months)
- Change in Diastolic Blood Pressure From Baseline to 6 Months(Change from Baseline to 6 Months)
- Waist Circumference(Change from Baseline to 6 Months)
- Triglycerides(Change from Baseline to 6 Months)
- Physical Activity (Self-report)(6 months)
- Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months(Change in 6 Months from Baseline)
- LDL Cholesterol(Change from Baseline to 6 Months)
- HbA1c(Change from Baseline to 6 Months)
- Energy Expenditure(Change from Baseline to 6 Months)
- Knowledge & Attitudes About Diabetes Risk(6 months)
- Fiber Intake(Change from Baseline to 6 Months)