The CARING Study: Creating and Restoring Health Through Nutrition Guidance

NCT05795439 | Recruiting DMC

• 1 other identifier: Pro00069695
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2diabetes; Type 2 Diabetes Treated With Insulin

Keywords

Diabetes; Type2; Insulin; A1C

Outcome Measures

Primary Outcomes (4)

• 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).

  16 weeks, 1 year, and 2 years

• Body Weight

  This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body weight.

  16 weeks, 1 year, and 2 years

• 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.

  16 weeks, Every 6 months during the 2-year follow-up period

• 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.

  16 weeks, Every 6 months during the 2-year follow-up period

Secondary Outcomes (1)

• Diet Acceptability

  16 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Low-fat, vegan diet BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead
• Blue Cross Blue Shield: collaborator
• Mayo Clinic: collaborator

Study Sites (1)

Physicians Committee for Responsible Medicine

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

RECRUITING

Related Publications (11)

• Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.

  PMID: 32487284 BACKGROUND

• Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810/pgm.2009.11.2074.

  PMID: 19940414 BACKGROUND

• Viguiliouk E, Kendall CW, Kahleova H, Rahelic D, Salas-Salvado J, Choo VL, Mejia SB, Stewart SE, Leiter LA, Jenkins DJ, Sievenpiper JL. Effect of vegetarian dietary patterns on cardiometabolic risk factors in diabetes: A systematic review and meta-analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1133-1145. doi: 10.1016/j.clnu.2018.05.032. Epub 2018 Jun 13.

  PMID: 29960809 BACKGROUND

• Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.

  PMID: 10496449 BACKGROUND

• Esselstyn CB Jr, Ellis SG, Medendorp SV, Crowe TD. A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice. J Fam Pract. 1995 Dec;41(6):560-8.

  PMID: 7500065 BACKGROUND

• Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.

  PMID: 1973470 BACKGROUND

• Tonstad S, Butler T, Yan R, Fraser GE. Type of vegetarian diet, body weight, and prevalence of type 2 diabetes. Diabetes Care. 2009 May;32(5):791-6. doi: 10.2337/dc08-1886. Epub 2009 Apr 7.

  PMID: 19351712 BACKGROUND

• Schepers J, Annemans L. The potential health and economic effects of plant-based food patterns in Belgium and the United Kingdom. Nutrition. 2018 Apr;48:24-32. doi: 10.1016/j.nut.2017.11.028. Epub 2017 Dec 15.

  PMID: 29469016 BACKGROUND

• Craig WJ, Mangels AR; American Dietetic Association. Position of the American Dietetic Association: vegetarian diets. J Am Diet Assoc. 2009 Jul;109(7):1266-82. doi: 10.1016/j.jada.2009.05.027.

  PMID: 19562864 BACKGROUND

• Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.

  PMID: 4337382 BACKGROUND

• Hernan MA, Robins JM. Per-Protocol Analyses of Pragmatic Trials. N Engl J Med. 2017 Oct 5;377(14):1391-1398. doi: 10.1056/NEJMsm1605385. No abstract available.

  PMID: 28976864 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Diet, Fat-Restricted; Diet, Vegan

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, Vegetarian; Diet, Plant-Based

Study Officials

• Neal Barnard, MD

  Physicians Committee for Responsible Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Macy Sutton, MS

CONTACT

202-527-7363; msutton@pcrm.org

Arathi Jayaraman

CONTACT

ajayaraman@pcrm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The control group will be asked to stay on their usual diet.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: July 11, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)