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

Blood Pressure Clinical Trial

Official title:

The Feasibility, Implementation and Efficacy of a Plant-Based Weight-Loss Program in a Practice-Based Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04091516
• Other study ID #: Pro00037092
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Body Weight
• Diabete Mellitus
• Diabetes Mellitus
• Lipid Disorder
• Lipid Metabolism Disorders
• PreDiabetes
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Barnard Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	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.	Change from baseline to 12 weeks
Secondary	Blood pressure	Blood pressure will be measured using an automated oscillometric device.	Change from baseline to 12 weeks
Secondary	Plasma cholesterol and triacylglycerol concentrations	Will be measured using standard methods.	Change from baseline to 12 weeks
Secondary	hemoglobin A1c	will be measured using standard methods.	Change from baseline to 12 weeks
Secondary	Body Composition	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.	Change from baseline to 12 weeks