Collaborations for Health Improvement in East Harlem-Project HEED
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Change in Weight From Baseline to 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •< 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
研究组 & 干预措施
Peer-Led Lifestyle Education on Weight Loss
Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes.
干预措施: Peer-Led Lifestyle Education on Weight Loss (Behavioral)
Delayed Intervention
The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
干预措施: Peer-Led Lifestyle Education on Weight Loss (Behavioral)
结局指标
主要结局
Change in Weight From Baseline to 6 Months
时间窗: Change from Baseline to 6 Months
次要结局
- HDL Cholesterol(Change from Baseline to 6 Months)
- Total Cholesterol(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)
- 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)