The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Sponsor

Physicians Committee for Responsible Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05795439

Collaborator

Blue Cross Blue Shield (Other)

700

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type2diabetes Type 2 Diabetes Treated With Insulin	Behavioral: Low-fat, vegan diet	N/A

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 and compared with that of a control population selected from Blue Cross Blue Shield subscribers.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Investigator)

Masking Description:

The control group will be asked to stay on their usual diet.

Primary Purpose:

Treatment

Official Title:

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group 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.	Behavioral: Low-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.
No Intervention: Control Group The Control group arm of participants will be asked to maintain their regular, pre-study diet.

Arm

Intervention/Treatment

Experimental: Intervention Group

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.

Behavioral: Low-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.

No Intervention: Control Group

The Control group arm of participants will be asked to maintain their regular, pre-study diet.

Outcome Measures

Primary Outcome Measures

Medical Utilization [16 weeks]
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]
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]
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]
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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
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