Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05795439

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Led by Physicians Committee for Responsible Medicine · Updated on 2026-04-13

700

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

P

Physicians Committee for Responsible Medicine

Lead Sponsor

B

Blue Cross Blue Shield

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the health benefits of nutrition education and a low-fat, vegan diet for individuals with type 2 diabetes who are Blue Cross Blue Shield subscribers. The study compares participants who receive nutrition guidance with a control group maintaining their usual diet to assess potential healthcare cost savings and health improvements. Participants in the intervention group will attend weekly online classes on nutrition and health while following a low-fat, vegan diet for 16 weeks. This diet focuses on whole grains, vegetables, legumes, and fruits, with no animal products or added oils, designed to be low in fat and rich in fiber. The control group will continue with their regular diet. Weekly classes continue for two years, and medical and laboratory assessments will be conducted throughout this period. Participants will undergo assessments of body weight, plasma lipids, HbA1C, dietary intake, and adherence at the start and after 16 weeks. Plasma lipids and HbA1C will be measured every six months during the two-year follow-up. Medical utilization data will be tracked for two years to compare health outcomes between groups. The study involves regular evaluations to monitor diet acceptability and health markers, ensuring ongoing support and data collection over the full study duration.

CONDITIONS

Brief Title

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 study components including following a plant-based diet for 16 weeks, attending weekly online classes for 16 weeks, and keeping physical activity level consistent during this period
Not Eligible

You will not qualify if you...

  • Diagnosis of type 1 diabetes or endocrine conditions affecting body weight such as pituitary abnormality or Cushing's syndrome
  • Smoking during the past six months
  • Alcohol use exceeding 2 drinks per day or history of alcohol abuse with current use
  • Current or unresolved past drug abuse
  • Recently gave birth, pregnant, or plans to become pregnant before or during the study
  • Unstable medical or psychiatric conditions
  • 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 or palliative care
  • Active participation in specific BCBSM diabetes or case management programs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or online)

Outpatient Treatment

Duration - 16 weeks

Participants in the intervention group attend weekly online classes on nutrition and health and follow a low-fat, vegan diet for 16 weeks.

Weekly online classes for 16 weeks

Follow-up

Duration - 2 years

Participants have their plasma lipids and HbA1C assessed every 6 months during a 2-year follow-up. Weekly online classes continue to be offered during this period. Medical utilization and body weight are tracked at 16 weeks, 1 year, and 2 years.

Assessments every 6 months and weekly online classes for up to 2 years

Trial Site Locations

Total: 1 location

1

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, United States, 20016

Actively Recruiting

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Research Team

M

Macy Sutton, MS

A

Arathi Jayaraman

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Effect of vegetarian dietary patterns on cardiometabolic risk factors in diabetes: A systematic review and meta-analysis of randomized controlled trials.

Effie Viguiliouk, Cyril Wc Kendall, Hana Kahleová...

https://pubmed.ncbi.nlm.nih.gov/29960809

A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice.

C B Esselstyn, S G Ellis, S V Medendorp...

https://pubmed.ncbi.nlm.nih.gov/7500065

Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge.

W T Friedewald, R I Levy, D S Fredrickson

https://pubmed.ncbi.nlm.nih.gov/4337382