RECRUITING

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Conditions

Type2diabetes Type 2 Diabetes Treated with Insulin Diabetes Type2 Insulin A1C

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Quick Facts

Study Start:2023-07-11

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05795439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Macy Sutton, MS

CONTACT

202-527-7363

msutton@pcrm.org

Arathi Jayaraman

CONTACT

ajayaraman@pcrm.org

Principal Investigator

Neal Barnard, MD

PRINCIPAL_INVESTIGATOR

Physicians Committee for Responsible Medicine

Study Locations (Sites)

Physicians Committee for Responsible Medicine

Washington, District of Columbia, 20016

United States

Collaborators and Investigators

Sponsor: Physicians Committee for Responsible Medicine

Neal Barnard, MD, PRINCIPAL_INVESTIGATOR, Physicians Committee for Responsible Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-11

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-07-11

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Diabetes
Type2
Insulin
A1C

Additional Relevant MeSH Terms

Type2diabetes
Type 2 Diabetes Treated with Insulin