Clinical trial NCT05795439: 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
Overall status: RECRUITING
Phase: NA
Conditions: Type2diabetes
Type 2 Diabetes Treated With Insulin
Keywords: Diabetes
Type2
Insulin
A1C
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
First posted: 2023-04-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 for another 2 years and compared with that of a control population selected from Blue Cross Blue Shield subscribers. Weekly classes will be offered for the whole 2-year follow-up period. Plasma lipids and HbA1C will be assessed every 6 months during the 2-year follow-up period.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Medical Utilization
timeFrame: 16 weeks, 1 year, and 2 years
measure: Body Weight
timeFrame: 16 weeks, 1 year, and 2 years
measure: Plasma Lipid Concentrations
timeFrame: 16 weeks, Every 6 months during the 2-year follow-up period
measure: HbA1C
timeFrame: 16 weeks, Every 6 months during the 2-year follow-up period
Secondary outcomes:
measure: Diet Acceptability
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Physicians Committee for Responsible Medicine
state: District of Columbia
Study officials:
affiliation: Physicians Committee for Responsible Medicine
name: Neal Barnard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810/pgm.2009.11.2074.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.