Image

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details
    Type2diabetes
    Type 2 Diabetes Treated With Insulin

NCT05795439

Physicians Committee for Responsible Medicine

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.