The CARING Study: Creating and Restoring Health Through Nutrition Guidance (NCT05795439) | Clinical Trial Compass
RecruitingNot Applicable
The CARING Study: Creating and Restoring Health Through Nutrition Guidance
United States700 participantsStarted 2023-07-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months
✓. Male or female
✓. Age at least 18 years
✓. Have a diagnosis of type 2 diabetes
✓. Ability and willingness to participate in all components of the study, including:
✓. Following a plant-based diet for the initial 16 weeks of the study;
✓. Attending weekly online classes for the initial 16 weeks of the study; and
✓. Keeping physical activity level consistent throughout the initial 16 weeks of the study.
Exclusion criteria
✕. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
✕. Smoking during the past six months
✕. 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
✕. Current or unresolved past drug abuse
✕. Recently gave birth, pregnant, or plans to become pregnant before or during the study period
What they're measuring
1
Medical Utilization
Timeframe: 16 weeks, 1 year, and 2 years
2
Body Weight
Timeframe: 16 weeks, 1 year, and 2 years
3
Plasma Lipid Concentrations
Timeframe: 16 weeks, Every 6 months during the 2-year follow-up period
4
HbA1C
Timeframe: 16 weeks, Every 6 months during the 2-year follow-up period
Trial details
NCT IDNCT05795439
SponsorPhysicians Committee for Responsible Medicine