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The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Primary Purpose

Type2diabetes, Type 2 Diabetes Treated With Insulin

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-fat, vegan diet
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2diabetes focused on measuring Diabetes, Type2, Insulin, A1C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Physicians Committee for Responsible MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Medical Utilization
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
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
This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in plasma lipid concentrations.
HbA1C
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
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.

Full Information

First Posted
March 8, 2023
Last Updated
June 21, 2023
Sponsor
Physicians Committee for Responsible Medicine
Collaborators
Blue Cross Blue Shield
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1. Study Identification

Unique Protocol Identification Number
NCT05795439
Brief Title
The CARING Study: Creating and Restoring Health Through Nutrition Guidance
Official Title
The CARING Study: Creating and Restoring Health Through Nutrition Guidance
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine
Collaborators
Blue Cross Blue Shield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes, Type 2 Diabetes Treated With Insulin
Keywords
Diabetes, Type2, Insulin, A1C

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
The control group will be asked to stay on their usual diet.
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The Control group arm of participants will be asked to maintain their regular, pre-study diet.
Intervention Type
Behavioral
Intervention Name(s)
Low-fat, vegan diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medical Utilization
Description
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).
Time Frame
16 weeks
Title
Body Weight
Description
This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body weight.
Time Frame
16 weeks
Title
Plasma Lipid Concentrations
Description
This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in plasma lipid concentrations.
Time Frame
16 weeks
Title
HbA1C
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Diet Acceptability
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle N Holtz
Phone
2025277363
Email
dholtz@pcrm.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Znayenko-Miller
Email
tznayenkomiller@pcrm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Barnard, MD
Organizational Affiliation
Physicians Committee for Responsible Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physicians Committee for Responsible Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Physicians CFR Medicine
Phone
2025277363
Email
dholtz@pcrm.org

12. IPD Sharing Statement

Plan to Share IPD
No
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The CARING Study: Creating and Restoring Health Through Nutrition Guidance

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