Nutrition guidance for managing type 2 diabetes

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

This study is testing if online nutrition classes and a low-fat vegan diet can help people with type 2 diabetes who have Blue Cross Blue Shield insurance improve their health over 16 weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 700 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Physicians Committee for Responsible Medicine (other)
• Locations: 1 site (Washington D.C., District of Columbia)
• Trial ID: NCT05795439 on ClinicalTrials.gov

What this trial studies

The CARING study evaluates the health benefits of nutrition education specifically for Blue Cross Blue Shield subscribers with type 2 diabetes. Participants will be randomly assigned to either an intervention group, which will attend weekly online nutrition classes and follow a low-fat, vegan diet for 16 weeks, or a control group. Key health metrics such as body weight, plasma lipids, and HbA1C levels will be measured at the start and after 16 weeks, with ongoing monitoring of medical utilization for two years. The study aims to assess both health outcomes and potential cost savings for the insurance provider.

Who should consider this trial

Good fit: Ideal candidates are Blue Cross Blue Shield subscribers aged 18 and older with a diagnosis of type 2 diabetes.

Not a fit: Patients with type 1 diabetes or those with endocrine conditions affecting body weight will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of type 2 diabetes through dietary changes, potentially reducing healthcare costs.

How similar studies have performed: Other studies have shown positive outcomes with dietary interventions for diabetes management, suggesting this approach may be effective.

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 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

Where this trial is running

Washington D.C., District of Columbia

• Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States (RECRUITING)

Study contacts

• Principal investigator: Neal Barnard, MD — Physicians Committee for Responsible Medicine
• Study coordinator: Macy Sutton, MS

Conditions: Type2diabetes, Type 2 Diabetes Treated With Insulin, Diabetes, Type2, Insulin, A1C