Intensive Lifestyle Intervention for Type 2 Diabetics: The Kaiser Permanente TLC Pilot
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- HBAIC before and after intervention
研究概览
简要总结
The purpose of this study is to determine if a healthy lifestyle intervention can significantly improve blood sugar control in type 2 diabetics over a course of 3 months.
详细描述
Peer reviewed research studies have proven the benefits of lifestyle interventions including the reversal of coronary artery disease and of diabetes. Experts agree that such a lifestyle must include a diet rich in whole, grown foods while low in saturated fat and cholesterol; regular physical activity; and healthy ways to cope with stress.
There are several challenges with implementing such lifestyle interventions such as educating the general public and health care providers to the components of this lifestyle and in getting people to adopt these healthy lifestyle changes.
While retreat-style, intensive lifestyle programs have shown that these obstacles can be overcome, they require monetary and time investments generally not feasible for the general public.
A community-based, lifestyle program such as 'The Coronary Health Improvement Project' program offers similar potential benefits at a more reasonable cost. It does so through an intensive education (32 hours total) taught over 4 weeks, followed by an 8-week consolidation period which include live or DVD based group sessions, discussions led by a program facilitator, and medical monitoring.
Kaiser Permanente, the leading Health maintenance organization in the nation, places special focus and significant resources into preventive medicine and health promotion, providing services to thousands of plan members but none with the level of intensity of 'The Coronary Health Improvement Project'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •English-speaking patients > 18 years of age, with at least 6 months of membership, who have type 2 diabetes.
- •Patients must have a recent HbA1C lab value > 8.0, and have had at least 2 previous HbA1C measures during the previous 6-12 months.
- •Patients with HbA1C values that are consistently > 8.0 over the previous 6-12 months will be invited to participate.
排除标准
- •current excessive alcohol use (drinking > 14 alcohol beverages per week for men or > 7 per week for women or > 4 per day for men or > 2 per day for women on 2 or more occasions each month)
- •current use of illegal or street drugs,
- •severely decreased functional capacity (shortness of breath or chest pain at rest or with minimal activity), and/or
- •suicidal thoughts or depression, will
- •Patients with severely limited physical ability
结局指标
主要结局
HBAIC before and after intervention
时间窗: 3 months
Baseline HbA1C will be measured within two weeks of the start of the intervention. Follow-up HbA1C will be measured at 12 weeks after the start of the intervention, as HbA1C is a measure of glycemic control over approximately 12 weeks.
次要结局
- Average weekly blood sugar(3 months)
- waist circumference(3 months)
- Lipids(3 months)
- Blood pressure(3 months)
- Weight(3 months)