The CARING Study: Creating and Restoring Health Through Nutrition Guidance

April 6, 2026 updated by: Physicians Committee for Responsible Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Physicians Committee for Responsible Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The Intervention group arm of participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks.
Behavioral: Low-fat, vegan diet
The intervention diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Participants will also be guided to favor foods with a low glycemic index. Animal products and added oils will be excluded. The diet is designed to derive approximately 10% of energy from fat, approximately 10-15% of energy from protein, and the remainder from mostly complex carbohydrates. The diet will also provide approximately 40 g of fiber per day.
No Intervention: Control Group
The Control group arm of participants will be asked to maintain their regular, pre-study diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Utilization
Time Frame: 16 weeks, 1 year, and 2 years
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
Body Weight
Time Frame: 16 weeks, 1 year, and 2 years
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
Plasma Lipid Concentrations
Time Frame: 16 weeks, Every 6 months during the 2-year follow-up period
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
HbA1C
Time Frame: 16 weeks, Every 6 months during the 2-year follow-up period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet Acceptability
Time Frame: 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physicians Committee for Responsible Medicine

Collaborators

Mayo Clinic
Blue Cross Blue Shield

Investigators

  • Principal Investigator: Neal Barnard, MD, Physicians Committee for Responsible Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00069695

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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