Type2diabetes, Type 2 Diabetes Treated With Insulin
Conditions
Keywords
Diabetes, Type2, Insulin, A1C
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.
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.
Interventions
BEHAVIORALLow-fat, vegan diet
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.
Sponsors
Physicians Committee for Responsible Medicine
Blue Cross Blue Shield
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The control group will be asked to stay on their usual diet.
Intervention model description
One arm, the intervention group, will be randomly assigned to be on a low-fat vegan diet for the duration of the study. The other arm, the control group, will maintain their pre-study diet for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical Utilization | 16 weeks, 1 year, and 2 years | This study will assess the effectiveness of a series of plant-based nutrition classes on health changes, measured by combined subscriber and insurance total cost of care (healthcare and health benefits). |
| Body Weight | 16 weeks, 1 year, and 2 years | This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body weight. |
| Plasma Lipid Concentrations | 16 weeks, Every 6 months during the 2-year follow-up period | This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in plasma lipid concentrations. |
| HbA1C | 16 weeks, Every 6 months during the 2-year follow-up period | This study will assess the association of attending a series of plant-based nutrition classes on with pre-post changes in glycemic control in individuals with type 2 diabetes as assessed by hemoglobic A1c (HbA1c) and use of medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diet Acceptability | 16 weeks | In addition, this study will assess the impact of association of attending a series of plant-based nutrition classes on pre-post changes in diet acceptability. Diet acceptability will be determined using the Food Acceptability Questionnaire (FAQ), asking participants to think about foods they have consumed in the prior two weeks to taking the FAQ, where higher scores indicate greater acceptability. There are eleven questions ranking answers on a scale of 1-7, and one question ranking answers on a scale from 1-13. |
Countries
United States
Contacts
CONTACTMacy Sutton, MS
CONTACTArathi Jayaraman
PRINCIPAL_INVESTIGATORNeal Barnard, MD
Physicians Committee for Responsible Medicine
Outcome results
None listed