NCT05795439 · Physicians Committee for Responsible Medicine
The CARING Study: Creating and Restoring Health Through Nutrition Guidance
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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).
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months
- Male or female
- Age at least 18 years
- Have a diagnosis of type 2 diabetes
- Ability and willingness to participate in all components of the study, including:
- Following a plant-based diet for the initial 16 weeks of the study;
- Attending weekly online classes for the initial 16 weeks of the study; and
- Keeping physical activity level consistent throughout the initial 16 weeks of the study.
Exclusion criteria
- Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
- Smoking during the past six months
- 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
- Current or unresolved past drug abuse
- Recently gave birth, pregnant, or plans to become pregnant before or during the study period
- Unstable medical or psychiatric status
- Cancer diagnosis
- Chronic kidney disease, stage 4 or 5
- Evidence of an eating disorder
- Lack of English fluency
- Bariatric surgery in the last 6 months
- Institutional custodial care
- End of life
- Palliative Care
- Actively engaged in specific BCBSM diabetes programs and case management programs
Where
- Washington D.C., District of Columbia
Collaborators
Blue Cross Blue Shield, Mayo Clinic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations