Recruiting
The CARING Study: Creating and Restoring Health Through Nutrition Guidance
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.
ClinicalTrials.gov IDNCT05795439
PhaseNA
Enrollment700
SponsorPhysicians Committee for Responsible Medicine
Age18 Years
SexALL
Conditions studied
Type2diabetes, Type 2 Diabetes Treated With Insulin
About this study
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 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)
- HbA1C (16 weeks, Every 6 months during the 2-year follow-up period)
Eligibility information
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 locations
- Physicians Committee for Responsible Medicine, Washington D.C., District of Columbia 20016 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.