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The CARING Study: Creating and Restoring Health Through Nutrition Guidance

NCT05795439 · Physicians Committee for Responsible Medicine
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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.
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
Study design
Enrollment target: 700 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-07-11
Estimated completion: 2028-12
Last updated: 2026-04-13
Interventions
Behavioral: Low-fat, vegan diet
Primary outcomes
  • Medical Utilization (16 weeks, 1 year, and 2 years)
  • Body Weight (16 weeks, 1 year, and 2 years)
  • Plasma Lipid Concentrations (16 weeks, Every 6 months during the 2-year follow-up period)
Sponsor
Physicians Committee for Responsible Medicine · other
With: Blue Cross Blue Shield, Mayo Clinic
Contacts & investigators
ContactMacy Sutton, MS · contact · msutton@pcrm.org · 202-527-7363
ContactArathi Jayaraman · contact · ajayaraman@pcrm.org
InvestigatorNeal Barnard, MD · principal_investigator, Physicians Committee for Responsible Medicine
All locations (1)
Physicians Committee for Responsible MedicineRecruiting
Washington D.C., District of Columbia, United States
The CARING Study: Creating and Restoring Health Through Nutrition Guidance · TrialPath