Feasibility & Implementation of a Plant-Based Weight-Loss Program in an Office-Based Setting

• ClinicalTrials.gov Identifier: NCT04091516
• Recruitment Status: Active, not recruiting
• First Posted: September 16, 2019
• Last Update Posted: February 24, 2023
• Sponsor: Physicians Committee for Responsible Medicine
• Information provided by (Responsible Party): Physicians Committee for Responsible Medicine

Study Description

Brief Summary:

This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.

Condition or disease	Intervention/treatment	Phase
Weight Loss; Blood Pressure; Lipid Disorder; PreDiabetes; Diabete Mellitus	Behavioral: Low-fat plant-based diet	Not Applicable

Detailed Description:

This will be a prospective interventional study to evaluate the feasibility, implementation and efficacy of 12-week plant-based, weight-loss program that is carried out in an office setting and is open to participation to the general public via local print and online advertising or whichever methods apply. The program will include weekly education and support, and assessment of blood pressure, lipids, hemoglobin A1c, and body composition before and after starting the program. The price of the program, $645, will cover the costs of weekly education, blood pressure check, laboratory testing and body composition analysis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective interventional study without a control group
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Feasibility, Implementation and Efficacy of a Plant-Based Weight-Loss Program in a Practice-Based Setting
• Actual Study Start Date: August 30, 2019
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm

Intervention/treatment

Low-fat plant-based diet; For 12 weeks, participants will follow a diet comprised of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. Except for light refreshments and tastings at the group sessions, no meals will be provided. Participants will handle their own food preparation and purchases, with guidance from the education team, with no restriction on energy intake.

Behavioral: Low-fat plant-based diet; Participants will follow a diet that consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. Except for light refreshments and tastings at the group sessions, no meals will be provided. Participants will handle their own food preparation and purchases, with guidance from the education team, with no restriction on energy intake.

Outcome Measures

Primary Outcome Measures :

1. Weight loss [ Time Frame: Change from baseline to 12 weeks ]
   With participants wearing light, indoor clothing but without shoes, body weight will be measured to the nearest 0.1 kg, using a digital scale. Body weight will also be assessed at each weekly session, but only data from the week 1 (pre-program) and week 12 (post-program) will be included in the analysis.

Secondary Outcome Measures :

1. Blood pressure [ Time Frame: Change from baseline to 12 weeks ]
   Blood pressure will be measured using an automated oscillometric device.
2. Plasma cholesterol and triacylglycerol concentrations [ Time Frame: Change from baseline to 12 weeks ]
   Will be measured using standard methods.
3. hemoglobin A1c [ Time Frame: Change from baseline to 12 weeks ]
   will be measured using standard methods.
4. Body Composition [ Time Frame: Change from baseline to 12 weeks ]
   Body composition will be measured by dual energy x-ray absorptometry (Lunar iDXA, GE Healthcare; Madison, WI) with Encore® 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Men and women age ≥18 years of age

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
• Lack of English fluency
• Inability to maintain current medication regimen
• Inability or unwillingness to participate in all components of the study

Contacts and Locations

Locations

United States, District of Columbia

Barnard Medical Center

Washington, District of Columbia, United States, 20016

Sponsors and Collaborators

Physicians Committee for Responsible Medicine

Investigators

• Principal Investigator: Vanita J Rahman, MD; Physicians Committee for Responsible Medicine

More Information

Publications:

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.

Barnard ND, Levin SM, Yokoyama Y. A systematic review and meta-analysis of changes in body weight in clinical trials of vegetarian diets. J Acad Nutr Diet. 2015 Jun;115(6):954-69. doi: 10.1016/j.jand.2014.11.016. Epub 2015 Jan 22.

Barnard N, Scherwitz L, Ornish D. Adherence and acceptability of a lowfat vegetarian diet among patients with cardiac disease. J Cardiopulmonary Rehabil 1992;12:423-31

Barnard N, Scialli A, Bertron P, Hurlock D, Edmonds K. Acceptability of a therapeutic low-fat, vegan diet in premenopausal women. J Nutr Educ 2000;32:314-9.

American Dietetic Association; Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian diets. J Am Diet Assoc. 2003 Jun;103(6):748-65. doi: 10.1053/jada.2003.50142.

Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ. Acceptability of a low-fat vegan diet compares favorably to a step II diet in a randomized, controlled trial. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):229-35. doi: 10.1097/00008483-200407000-00004.

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.

Barnard ND, Akhtar A, Nicholson A. Factors that facilitate compliance to lower fat intake. Arch Fam Med. 1995 Feb;4(2):153-8. doi: 10.1001/archfami.4.2.153.

Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.

U.S. Census Bureau. Quick Facts. District of Columbia. Internet: http://www.census.gov/quickfacts/table/RHI125215/11, accessed August 22, 2016.

• Responsible Party: Physicians Committee for Responsible Medicine
• ClinicalTrials.gov Identifier: NCT04091516
• Other Study ID Numbers: Pro00037092
• First Posted: September 16, 2019
• Last Update Posted: February 24, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Will make individual data available to other researchers upon request
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: December 31, 2020
• Access Criteria: Will make study data available upon request

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Physicians Committee for Responsible Medicine:

weight loss; body composition; lipids; hemoglobin A1c; blood pressure

Additional relevant MeSH terms:

Lipid Metabolism Disorders; Diabetes Mellitus; Body Weight; Weight Loss; Body Weight Changes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases