The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Physicians Committee for Responsible Medicine

Status: Enrolling

Conditions: Type2diabetes; Type 2 Diabetes Treated With Insulin

Treatments: Behavioral: Low-fat, vegan diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05795439

Pro00069695

Details and patient eligibility

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Low-fat, vegan diet

Control Group

No Intervention group

Description:

The Control group arm of participants will be asked to maintain their regular, pre-study diet.