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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05795439
Study type Interventional
Source Physicians Committee for Responsible Medicine
Contact Tatiana Znayenko-Miller
Phone 202-527-7317
Email tznayenkomiller@pcrm.org
Status Recruiting
Phase N/A
Start date July 11, 2023
Completion date December 2026