[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05795439":3,"trial-entities:NCT05795439":131,"trial-summary:NCT05795439":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":54,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":14,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":84,"overall_officials":91,"references":95,"see_also_links":130},"NCT05795439","Pro00069695","The CARING Study: Creating and Restoring Health Through Nutrition Guidance","RECRUITING","2028-12","2026-04","2026-04-13","2023-07-11","Physicians Committee for Responsible Medicine","OTHER",true,"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.","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.\n\nThe 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.",[18,19],"Type2diabetes","Type 2 Diabetes Treated With Insulin",[21,22,23,24],"Diabetes","Type2","Insulin","A1C","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},700,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Low-fat, vegan diet","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.",[38],"Intervention Group",[40,44,47,51],{"measure":41,"description":42,"timeFrame":43},"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",{"measure":45,"description":46,"timeFrame":43},"Body Weight","This study will assess the association of attending a series of plant-based nutrition classes with pre-post changes in body weight.",{"measure":48,"description":49,"timeFrame":50},"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",{"measure":52,"description":53,"timeFrame":50},"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.",[55],{"measure":56,"description":57,"timeFrame":58},"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.","16 weeks","ALL","18 Years",null,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion Criteria:\n\n1. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months\n2. Male or female\n3. Age at least 18 years\n4. Have a diagnosis of type 2 diabetes\n5. Ability and willingness to participate in all components of the study, including:\n\n   1. Following a plant-based diet for the initial 16 weeks of the study;\n   2. Attending weekly online classes for the initial 16 weeks of the study; and\n   3. Keeping physical activity level consistent throughout the initial 16 weeks of the study.\n\nExclusion Criteria:\n\n1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome\n2. Smoking during the past six months\n3. 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\n4. Current or unresolved past drug abuse\n5. Recently gave birth, pregnant, or plans to become pregnant before or during the study period\n6. Unstable medical or psychiatric status\n7. Cancer diagnosis\n8. Chronic kidney disease, stage 4 or 5\n9. Evidence of an eating disorder\n10. Lack of English fluency\n11. Bariatric surgery in the last 6 months\n12. Dementia\n13. Institutional custodial care\n14. End of life\n15. Palliative Care\n16. Actively engaged in specific BCBSM diabetes programs and case management programs",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":12,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"Washington D.C.","District of Columbia","20016","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Physicians CFR Medicine","CONTACT","2025277363","ajayaraman@pcrm.org",{"lat":82,"lon":83},38.89511,-77.03637,[85,89],{"name":86,"role":78,"phone":87,"email":88},"Macy Sutton, MS","202-527-7363","msutton@pcrm.org",{"name":90,"role":78,"email":80},"Arathi Jayaraman",[92],{"name":93,"affiliation":12,"role":94},"Neal Barnard, MD","PRINCIPAL_INVESTIGATOR",[96,100,103,106,109,112,115,118,121,124,127],{"pmid":97,"type":98,"citation":99},"32487284","BACKGROUND","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":101,"type":98,"citation":102},"19940414","Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810\u002Fpgm.2009.11.2074.",{"pmid":104,"type":98,"citation":105},"29960809","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\u002Fj.clnu.2018.05.032. Epub 2018 Jun 13.",{"pmid":107,"type":98,"citation":108},"10496449","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\u002Fs0002-9149(99)00290-8.",{"pmid":110,"type":98,"citation":111},"7500065","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":113,"type":98,"citation":114},"1973470","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\u002F0140-6736(90)91656-u.",{"pmid":116,"type":98,"citation":117},"19351712","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\u002Fdc08-1886. Epub 2009 Apr 7.",{"pmid":119,"type":98,"citation":120},"29469016","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\u002Fj.nut.2017.11.028. Epub 2017 Dec 15.",{"pmid":122,"type":98,"citation":123},"19562864","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\u002Fj.jada.2009.05.027.",{"pmid":125,"type":98,"citation":126},"4337382","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":128,"type":98,"citation":129},"28976864","Hernan MA, Robins JM. Per-Protocol Analyses of Pragmatic Trials. N Engl J Med. 2017 Oct 5;377(14):1391-1398. doi: 10.1056\u002FNEJMsm1605385. No abstract available.",[],{"nct_id":4,"conditions":132,"biomarkers":134},[133],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":14,"summary":136,"prompt_version":146},{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This interventional study plans to enroll 700 participants. Individuals with type 2 diabetes will be randomly selected and invited to participate, with a matched control group.","completed","The CARING Study: Nutrition Guidance for Type 2 Diabetes","The CARING study is looking at how a low-fat, vegan diet can help people with type 2 diabetes. This diet focuses on whole grains, vegetables, beans, and fruits, without limiting how much you eat. It also avoids animal products and added oils. The study wants to see if this diet can improve your health and potentially lower healthcare costs. To join, you need to be at least 18 years old, have type 2 diabetes, and be a Blue Cross Blue Shield subscriber for the past year. The study will measure things like your body weight and blood fat levels (plasma lipid concentrations) over two years to see how well the diet works. The current status of this study is unclear.","Your medical utilization will be tracked for two years after the initial 16-week intervention. Blood fat levels and HbA1C will be checked every six months during this two-year period.",120,"You would attend weekly online nutrition classes and follow a low-fat, vegan diet for the first 16 weeks. Body weight, blood fat levels, and other measures will be taken at the start and at 16 weeks.","Not stated in the trial record.",[35],"v2"]