Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Health Care utilization and costs using claims data
研究概览
简要总结
The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. The intervention is aimed at moderate weight loss (> 5-10%), improvement in diet quality and an increase in physical activity.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > 30 kg/m2, calculated from measured weight and height.
- •Type 2 diabetics on medication for their diabetes.
- •Age 20 -60 years of age.
- •Have phone.
- •Fluency in reading, writing and comprehension of English
- •Have Qualchoice as their primary health insurer.
排除标准
- •Depression, BDI score > 20
- •Pregnancy
研究组 & 干预措施
I
Usual medical care. They received written healthy lifestyle information
干预措施: Usual medical care (Behavioral)
2
Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in
干预措施: Lifestyle Case management (Behavioral)
结局指标
主要结局
Health Care utilization and costs using claims data
时间窗: one year
次要结局
- Weight change(one year)
- Change in hemoglobin A1c(One Year)
- Work days lost(One year)
- Disability Days(One year)
- Change in quality of life(one year)