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This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will meet with a physician and a registered dietitian once a week to learn about a plant-based diet and receive support and practical help in making the dietary changes. Body composition, blood sugar control, cholesterol levels, and food costs will be measured at the start and end of the study.
This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will participate in weekly physician- and dietitian-lead group classes and will receive education about a plant-based diet as well as support and practical tips for implementing the dietary changes. Participants will receive baseline and 12 week assessments including a DXA scan to assess body composition, HbA1c, lipid panel, and a food cost analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-fat, vegan diet | Experimental | All participants will be asked to follow a low-fat vegan diet. There are no other study arms or control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-fat, vegan diet | Behavioral | All participants will be asked to follow a low-fat vegan diet for the duration of the study. Participants will attend weekly classes where they we receive education and support. |
| Measure | Description | Time Frame |
|---|---|---|
| The feasibility of an online plant-based weight loss program in the community setting. | Feasibility will be assessed by the number of total participants that enroll in the program and complete both baseline and final assessments. | From baseline to the end of the intervention at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycated hemoglobin. | A1c will be measured using standard methods. | From baseline to the end of the intervention at 12 weeks. |
| Changes in total and LDL cholesterol levels. | Total and LDL cholesterol levels will be measured using standard methods. |
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Inclusion Criteria:
Age 19 or older in Nebraska and Alabama. Age 21 or older in Puerto Rico. Age 18 or older in all other states.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanita Rahman, MD, DipACLM | Contact | 202-567-2546 | vrahman@pcrm.org | |
| Roxanne Becker, MBChB, DipIBLM | Contact | rbecker@pcrm.org |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39556398 | Background | Kahleova H, Sutton M, Maracine C, Nichols D, Monsivais P, Holubkov R, Barnard ND. Food Costs of a Low-Fat Vegan Diet vs a Mediterranean Diet: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445784. doi: 10.1001/jamanetworkopen.2024.45784. | |
| 37669055 | Background | Kahleova H, Sutton M, Maracine C, Nichols D, Monsivais P, Holubkov R, Barnard ND. Vegan Diet and Food Costs Among Adults With Overweight: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332106. doi: 10.1001/jamanetworkopen.2023.32106. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| From baseline to the end of the intervention at 12 weeks. |
| Changes in body composition. | Body composition will be measured by dual energy x-ray absorptometry (Lunar iDXA, GE Healthcare; Madison, WI) with EncoreĀ® 2005 v.9.15.010 software. The iDXA can measure body composition with low x-ray exposure and short scanning time. The iDXA unit will be calibrated daily using the GE Lunar calibration phantom, and a trained operator will perform all scans following standard protocol for participant positioning. The iDXA is equipped with the CoreScan module (GE Healthcare, Madison, WI), which can also provide an estimate of visceral adipose tissue volume and mass. | From baseline to the end of the intervention at 12 weeks. |
| Food costs of a baseline diet and a low-fat plant-based diet. | Study participants will be asked to provide a food consumption record of three consecutive days (including two weekdays and one weekend day). Participants will be asked to include the specific brands, portions, names of retailers and restaurants where the food was purchased. A study team member will review the food record with the participants. We will then calculate the total cost of the food consumed during the 3-day period using cost data from the retailers' and restaurants' websites or by calling the specific restaurants and retailers. | From baseline to the end of the intervention at 12 weeks. |
| 35011091 | Background | Stanford J, Zuck M, Stefoska-Needham A, Charlton K, Lambert K. Acceptability of Plant-Based Diets for People with Chronic Kidney Disease: Perspectives of Renal Dietitians. Nutrients. 2022 Jan 4;14(1):216. doi: 10.3390/nu14010216. |
| 19167953 | Background | Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049. |
| 38982435 | Background | Emamat H, Jamshidi A, Farhadi A, Ghalandari H, Ghasemi M, Tangestani H. The association between the visceral to subcutaneous abdominal fat ratio and the risk of cardiovascular diseases: a systematic review. BMC Public Health. 2024 Jul 9;24(1):1827. doi: 10.1186/s12889-024-19358-0. |
| 28938794 | Background | Yokoyama Y, Levin SM, Barnard ND. Association between plant-based diets and plasma lipids: a systematic review and meta-analysis. Nutr Rev. 2017 Sep 1;75(9):683-698. doi: 10.1093/nutrit/nux030. |
| 33252690 | Background | Kahleova H, Petersen KF, Shulman GI, Alwarith J, Rembert E, Tura A, Hill M, Holubkov R, Barnard ND. Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025454. doi: 10.1001/jamanetworkopen.2020.25454. |
| 29425120 | Background | Kahleova H, Tura A, Hill M, Holubkov R, Barnard ND. A Plant-Based Dietary Intervention Improves Beta-Cell Function and Insulin Resistance in Overweight Adults: A 16-Week Randomized Clinical Trial. Nutrients. 2018 Feb 9;10(2):189. doi: 10.3390/nu10020189. |
| 37419391 | Background | Campbell TM, Campbell EK, Attia J, Ventura K, Mathews T, Chhabra KH, Blanchard LM, Wixom N, Faniyan TS, Peterson DR, Harrington DK, Wittlin SD. The acute effects of a DASH diet and whole food, plant-based diet on insulin requirements and related cardiometabolic markers in individuals with insulin-treated type 2 diabetes. Diabetes Res Clin Pract. 2023 Aug;202:110814. doi: 10.1016/j.diabres.2023.110814. Epub 2023 Jul 5. |
| 16873779 | Background | Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606. |
| 40085919 | Background | Gwira JA, Fryar CD, Gu Q. Prevalence of Total, Diagnosed, and Undiagnosed Diabetes in Adults: United States, August 2021-August 2023. NCHS Data Brief. 2024 Nov;(516):CS354814. doi: 10.15620/cdc/165794. |
| 33544066 | Background | Barnard ND, Alwarith J, Rembert E, Brandon L, Nguyen M, Goergen A, Horne T, do Nascimento GF, Lakkadi K, Tura A, Holubkov R, Kahleova H. A Mediterranean Diet and Low-Fat Vegan Diet to Improve Body Weight and Cardiometabolic Risk Factors: A Randomized, Cross-over Trial. J Am Nutr Assoc. 2022 Feb;41(2):127-139. doi: 10.1080/07315724.2020.1869625. Epub 2021 Feb 5. |
| 27423262 | Background | Global BMI Mortality Collaboration, Di Angelantonio E, Bhupathiraju ShN, Wormser D, Gao P, Kaptoge S, Berrington de Gonzalez A, Cairns BJ, Huxley R, Jackson ChL, Joshy G, Lewington S, Manson JE, Murphy N, Patel AV, Samet JM, Woodward M, Zheng W, Zhou M, Bansal N, Barricarte A, Carter B, Cerhan JR, Smith GD, Fang X, Franco OH, Green J, Halsey J, Hildebrand JS, Jung KJ, Korda RJ, McLerran DF, Moore SC, O'Keeffe LM, Paige E, Ramond A, Reeves GK, Rolland B, Sacerdote C, Sattar N, Sofianopoulou E, Stevens J, Thun M, Ueshima H, Yang L, Yun YD, Willeit P, Banks E, Beral V, Chen Zh, Gapstur SM, Gunter MJ, Hartge P, Jee SH, Lam TH, Peto R, Potter JD, Willett WC, Thompson SG, Danesh J, Hu FB. Body-mass index and all-cause mortality: individual-participant-data meta-analysis of 239 prospective studies in four continents. Lancet. 2016 Aug 20;388(10046):776-86. doi: 10.1016/S0140-6736(16)30175-1. Epub 2016 Jul 13. |
| 28626830 | Background | Kivimaki M, Kuosma E, Ferrie JE, Luukkonen R, Nyberg ST, Alfredsson L, Batty GD, Brunner EJ, Fransson E, Goldberg M, Knutsson A, Koskenvuo M, Nordin M, Oksanen T, Pentti J, Rugulies R, Shipley MJ, Singh-Manoux A, Steptoe A, Suominen SB, Theorell T, Vahtera J, Virtanen M, Westerholm P, Westerlund H, Zins M, Hamer M, Bell JA, Tabak AG, Jokela M. Overweight, obesity, and risk of cardiometabolic multimorbidity: pooled analysis of individual-level data for 120 813 adults from 16 cohort studies from the USA and Europe. Lancet Public Health. 2017 May 19;2(6):e277-e285. doi: 10.1016/S2468-2667(17)30074-9. eCollection 2017 Jun. |
| 39808758 | Background | Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021-August 2023. NCHS Data Brief. 2024 Sep;(508):10.15620/cdc/159281. doi: 10.15620/cdc/159281. |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |