Type2diabetes Clinical Trial
Official title:
The CARING Study: Creating and Restoring Health Through Nutrition Guidance
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.
| Status | Recruiting |
| Enrollment | 700 |
| Est. completion date | December 2026 |
| Est. primary completion date | December 2026 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 birth, pregnant, or plans to become pregnant before or during the study period 6. Unstable medical or psychiatric status 7. Cancer diagnosis 8. Chronic kidney disease, stage 4 or 5 9. Evidence of an eating disorder 10. Lack of English fluency 11. Bariatric surgery in the last 6 months 12. Dementia 13. Institutional custodial care 14. End of life 15. Palliative Care 16. Actively engaged in specific BCBSM diabetes programs and case management programs |
| Country | Name | City | State |
|---|---|---|---|
| United States | Physicians Committee for Responsible Medicine | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Physicians Committee for Responsible Medicine | Blue Cross Blue Shield |
United States,
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Medical Utilization | 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). | 16 weeks, 1 year, and 2 years | |
| Primary | Body Weight | This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body weight. | 16 weeks, 1 year, and 2 years | |
| Primary | Plasma Lipid Concentrations | This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in plasma lipid concentrations. | 16 weeks, Every 6 months during the 2-year follow-up period | |
| Primary | HbA1C | 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. | 16 weeks, Every 6 months during the 2-year follow-up period | |
| Secondary | Diet Acceptability | In addition, this study will assess the impact of association of attending a series of plant-based nutrition classes on pre-post changes in diet acceptability. Diet acceptability will be determined using the Food Acceptability Questionnaire (FAQ), asking participants to think about foods they have consumed in the prior two weeks to taking the FAQ, where higher scores indicate greater acceptability. There are eleven questions ranking answers on a scale of 1-7, and one question ranking answers on a scale from 1-13. | 16 weeks |