Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Nutrition guidance for managing type 2 diabetes

Official title: The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Run by Physicians Committee for Responsible Medicine · NCT05795439 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment700 (estimated)
SponsorPhysicians Committee for Responsible Medicine
Academic / other
Locations1 site (Washington D.C., District of Columbia)
StatusRecruiting
StartedJuly 11, 2023
Main results expectedDecember 2027
Study endsDecember 2028
Registry record updatedApril 13, 2026
Trial IDNCT05795439 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: msutton@pcrm.org
  • Phone: 202-527-7363

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.