Lawrence Latino Diabetes Prevention Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Weight loss.
研究概览
简要总结
The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a >30% probability of developing diabetes in the next 7.5 years per a predictive equation. The project was conducted in Lawrence, Massachusetts; a predominantly Caribbean-origin urban Latino community. Individuals were identified primarily from a community health center's patient panel, screened for study eligibility, randomized to either a usual care or a lifestyle intervention condition, and followed for one year.
详细描述
The group format of the intervention included 13 group sessions complemented by 3 individual home contacts over one year and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist. Study measures included demographics, Stern predictive equation components (age, gender, ethnicity, fasting glucose, systolic blood pressure, HDL-cholesterol, body mass index, and family history of diabetes), glycosylated hemoglobin, dietary intake, physical activity, depressive symptoms, social support, and quality of life. Body weight was measured at baseline, 6-months, and one-year; all other measures were assessed at baseline and one-year. All surveys were orally administered in Spanish.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is Latino/Hispanic;
- •Has a 7.5 year likelihood of becoming diabetic of greater than or equal to 30% as predicted by the Stern formula;
- •Is greater than or equal to 25 years of age;
- •Has a BMI greater than or equal to 24 kg m2.
排除标准
- •An inability or unwillingness to give informed consent;
- •Has clinically diagnosed diabetes, or a fasting blood sugar of greater than or equal to 126 mg/dl;
- •Plans to move out of the area within the study period;
- •Has a psychiatric illness which limits ability to participate;
- •Has no telephone;
- •Is unable to walk unaided, or cannot walk five city blocks (1/4 mile) without stopping;
- •Is not cleared for the PA component by the pt's GLFHC primary care provider;
- •Has a medical conditions likely to limit lifespan;
- •Is on medications or has a medical condition that interfere with the assessment for diabetes.
结局指标
主要结局
Weight loss.
时间窗: 1 year
HgbA1c
时间窗: 1 year
次要结局
- Change in fasting blood sugar.(1 year)
- Changes in LDL- and HDL-cholesterol.(1 year)
- Change in blood pressure.(1 year)
- Change in depression.(1 year)
- Change in quality of life.(1 year)