NCT05795439 The CARING Study: Creating and Restoring Health Through Nutrition Guidance
| NCT ID | NCT05795439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Physicians Committee for Responsible Medicine |
| Condition | Type2diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2023-07-11 |
| Primary Completion | 2027-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months 2. Male or female 3. Age at least 18 years 4. Have a diagnosis of type 2 diabetes 5. Ability and willingness to participate in all components of the study, including: 1. Following a plant-based diet for the initial 16 weeks of the study; 2. Attending weekly online classes for the initial 16 weeks of the study; and 3. Keeping physical activity level consistent throughout the initial 16 weeks of the study. Exclusion Criteria: 1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome 2. Smoking during the past six months 3. 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 4. Current or unresolved past drug abuse 5. Recently gave bi
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