The CARING Study: Creating and Restoring Health Through Nutrition Guidance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Medical Utilization
研究概览
简要总结
The CARING study assesses the health benefits of nutrition education for Blue Cross Blue Shield subscribers, as well as potential healthcare cost savings to subscribers and the insurance company.
详细描述
Among Blue Cross Blue Shield subscribers, individuals with type 2 diabetes will be randomly selected and invited to participate in an interventional trial. A control group matched for relevant variables will be selected from Blue Cross Blue Shield subscribers.
The Intervention group participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks. Body weight, plasma lipids, HbA1C, dietary intake and adherence, and food acceptability will be assessed at baseline and at 16 weeks. Their longer-term medical utilization will then be tracked for another 2 years and compared with that of a control population selected from Blue Cross Blue Shield subscribers. Weekly classes will be offered for the whole 2-year follow-up period. Plasma lipids and HbA1C will be assessed every 6 months during the 2-year follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The control group will be asked to stay on their usual diet.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months
- •Male or female
- •Age at least 18 years
- •Have a diagnosis of type 2 diabetes
- •Ability and willingness to participate in all components of the study, including:
- •Following a plant-based diet for the initial 16 weeks of the study;
- •Attending weekly online classes for the initial 16 weeks of the study; and
- •Keeping physical activity level consistent throughout the initial 16 weeks of the study.
排除标准
- •Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
- •Smoking during the past six months
- •Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- •Current or unresolved past drug abuse
- •Recently gave birth, pregnant, or plans to become pregnant before or during the study period
- •Unstable medical or psychiatric status
- •Cancer diagnosis
- •Chronic kidney disease, stage 4 or 5
- •Evidence of an eating disorder
- •Lack of English fluency
- •Bariatric surgery in the last 6 months
- •Institutional custodial care
- •End of life
- •Palliative Care
- •Actively engaged in specific BCBSM diabetes programs and case management programs
研究组 & 干预措施
Intervention Group
The Intervention group arm of participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks.
干预措施: Low-fat, vegan diet (Behavioral)
Control Group
The Control group arm of participants will be asked to maintain their regular, pre-study diet.
结局指标
主要结局
Medical Utilization
时间窗: 16 weeks, 1 year, and 2 years
This study will assess the effectiveness of a series of plant-based nutrition classes on health changes, measured by combined subscriber and insurance total cost of care (healthcare and health benefits).
Body Weight
时间窗: 16 weeks, 1 year, and 2 years
This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body weight.
Plasma Lipid Concentrations
时间窗: 16 weeks, Every 6 months during the 2-year follow-up period
This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in plasma lipid concentrations.
HbA1C
时间窗: 16 weeks, Every 6 months during the 2-year follow-up period
This study will assess the association of attending a series of plant-based nutrition classes on with pre-post changes in glycemic control in individuals with type 2 diabetes as assessed by hemoglobic A1c (HbA1c) and use of medications.
次要结局
- Diet Acceptability(16 weeks)