NCT01244152已完成2 期
Lifestyle Improvement Through Food and Exercise (LIFE): Self-Management in African Americans With Diabetes and Hypertension
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
The primary aim of the study is to design a group-based, culturally appropriate self-management skills training intervention for disadvantaged African-Americans with both diabetes and hypertension and to compile an intervention Manual of Operations (MOO). The investigators are developing an intervention to assist individuals in reducing weight and hemoglobin A1c.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus (HgA1c>7%), requiring the patient to take at least one tablet per day or one insulin injection per day and a diagnosis of hypertension (130/80) requiring them to take at least one medication per day;
- •Participants must identify themselves as African-American;
- •Participant resides in or proximal to the North Lawndale neighborhood;
- •Secure written permission from their physician to engage in moderate physical activity. This set of participants may be at high risk for cardiac disease and this exclusion avoids putting them at undue risk;
- •Participant must be overweight because the main goal of our intervention is weight loss of 5% or more of initial body weight.
排除标准
- •Diet-controlled diabetes;
- •Hypertension controlled with lifestyle modification only;
- •Endstage renal disease, stroke with paresis, congestive heart failure (NYHA class 3 or 4), or other major endorgan complication of diabetes;
- •Comorbid conditions limiting probable life span to <4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);
- •Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);
- •Unable to give informed consent;
- •Are under the age of 18-While type-2 diabetes and hypertension are increasing in those under the age of 18, adolescent medicine is a separate specialty area from adult medicine. Interventions should be targeted specifically toward this age group to take into consideration the specific emotional and psychological needs of adolescents;
- •Alcoholism as measured by the CAGE.screener for alcohol abuse.
结局指标
主要结局
Weight change
次要结局
- Hemoglobin A1C
研究者
研究点 (2)
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