The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Not Applicable

Recruiting

• Conditions: Type2diabetes; Type 2 Diabetes Treated with Insulin
• Interventions: Behavioral: Low-fat, vegan diet

• Registration Number: NCT05795439
• Lead 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.

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 Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-04-03
• Study Start: 2023-07-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Low-fat, vegan diet	The Intervention group arm of participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Physicians Committee for Responsible Medicine; 🇺🇸 Washington, District of Columbia, United States