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NCT05795439 | RECRUITING | Type2diabetes

The CARING Study: Creating and Restoring Health Through Nutrition Guidance
Sponsor:

Physicians Committee for Responsible Medicine

Brief Summary:

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.

Condition or disease

Type2diabetes

Type 2 Diabetes Treated With Insulin

Intervention/treatment

Low-fat, vegan diet

Phase

NA

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
Estimated Enrollment : 700 participants
Masking : SINGLE
Masking Description : The control group will be asked to stay on their usual diet.
Primary Purpose : TREATMENT
Official Title : The CARING Study: Creating and Restoring Health Through Nutrition Guidance
Actual Study Start Date : 2023-07-11
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Location Details

NCT05795439

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, District of Columbia

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, United States, 20016