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

Official title

Feasibility, Implementation, and Efficacy of a Plant-based Online Weight Loss Through Education and Resources Program and Study (POWER Study)

Overview

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.

Detailed description

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.

Interventions

• Behavioral Low-fat, vegan diet
  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.

Primary outcome measures

• The feasibility of an online plant-based weight loss program in the community setting. [Time frame: From baseline to the end of the intervention at 12 weeks.]

Secondary outcome measures (4)

• Changes in glycated hemoglobin. [Time frame: From baseline to the end of the intervention at 12 weeks.]
• Changes in total and LDL cholesterol levels. [Time frame: From baseline to the end of the intervention at 12 weeks.]
• Changes in body composition. [Time frame: From baseline to the end of the intervention at 12 weeks.]
• Food costs of a baseline diet and a low-fat plant-based diet. [Time frame: From baseline to the end of the intervention at 12 weeks.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07095543 · Pro00087270

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗