The CARING Study: Creating and Restoring Health Through Nutrition Guidance
Physicians Committee for Responsible Medicine
700 participants
Jul 11, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria16
- 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
- Unstable medical or psychiatric status
- Cancer diagnosis
- Chronic kidney disease, stage 4 or 5
- Evidence of an eating disorder
- Lack of English fluency
- Bariatric surgery in the last 6 months
- Dementia
- Institutional custodial care
- End of life
- Palliative Care
- Actively engaged in specific BCBSM diabetes programs and case management programs
Interventions
The intervention diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Participants will also be guided to favor foods with a low glycemic index. Animal products and added oils will be excluded. The diet is designed to derive approximately 10% of energy from fat, approximately 10-15% of energy from protein, and the remainder from mostly complex carbohydrates. The diet will also provide approximately 40 g of fiber per day.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05795439