Plant-Based Online Weight Loss Through Education and Resources Program and Study

NCT07095543 | Not Yet Recruiting

• 1 other identifier: Pro00087270
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes; Overweight and Obese Adults

Keywords

Plant-based diet; Vegan diet; type 2 diabetes; Weight loss; Overweight; Obesity; Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Changes in glycated hemoglobin.

  From baseline to the end of the intervention at 12 weeks.

• Changes in total and LDL cholesterol levels.

  From baseline to the end of the intervention at 12 weeks.

• Changes in body composition.

  From baseline to the end of the intervention at 12 weeks.

• Food costs of a baseline diet and a low-fat plant-based diet.

  From baseline to the end of the intervention at 12 weeks.

Study Arms (1)

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.

Behavioral: Low-fat, vegan diet

Interventions

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.

Low-fat, vegan diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• U.S. men and women meeting the age of majority, defined as follows:
• Age 19 or older in Nebraska and Alabama. Age 21 or older in Puerto Rico. Age 18 or older in all other states.
• Able and willing to travel to Washington DC for a dual-energy х-rау absorptiometry (DXA) scans before and after the program.
• Able and willing to complete laboratory assessments at a local LabCorp facility before and after the program.
• Able and willing to participate in all components of the study.
• BMI of 25 or more (23 or more in persons of Asian origin).
• Access to the internet.
• English fluency.

You may not qualify if:

• Use of recreational drugs in the past 6 months.
• Pregnancy or intention to become pregnant during the study period, as verified by self-report.
• Unstable medical or psychiatric illness.
• Inability to maintain medication regimen as prescribed by personal healthcare provider.
• Current or expected use of any weight loss medication during the study period, including but not limited to, glucagon-like peptide-1 (GLP-1) receptor agonists and combination GLP-1 receptor/glucose-dependent insulinotropic polypeptide (GIP) agonists.
• Use of any weight loss medication within the 12 months preceding the study period, including but not limited to, glucagon-like peptide-1 (GLP-1) receptor agonists and combination GLP-1 receptor/glucose-dependent insulinotropic polypeptide (GIP) agonists.
• Body weight greater than 182 kg.
• Current diagnosis of eating disorder.
• Intention to follow another weight loss method during the study period.

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Related Publications (15)

• 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.

  PMID: 39556398 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.

  PMID: 37669055 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.

  PMID: 35011091 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.

  PMID: 19167953 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.

  PMID: 38982435 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.

  PMID: 28938794 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.

  PMID: 33252690 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.

  PMID: 29425120 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.

  PMID: 37419391 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.

  PMID: 16873779 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.

  PMID: 40085919 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.

  PMID: 33544066 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.

  PMID: 27423262 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.

  PMID: 28626830 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.

  PMID: 39808758 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Weight Loss; Obesity

Interventions

Diet, Fat-Restricted; Diet, Vegan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Vanita Rahman, MD, DipACLM

CONTACT

202-567-2546; vrahman@pcrm.org

Roxanne Becker, MBChB, DipIBLM

CONTACT

rbecker@pcrm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 31, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share