Clinical trial NCT04091516: Feasibility & Implementation of a Plant-Based Weight-Loss Program in an Office-Based Setting
Official title: The Feasibility, Implementation and Efficacy of a Plant-Based Weight-Loss Program in a Practice-Based Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Loss
Blood Pressure
Lipid Disorder
PreDiabetes
Diabete Mellitus
Keywords: weight loss
body composition
lipids
hemoglobin A1c
blood pressure
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective interventional study without a control group
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Weight loss
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: Change from baseline to 12 weeks
measure: Plasma cholesterol and triacylglycerol concentrations
timeFrame: Change from baseline to 12 weeks
measure: hemoglobin A1c
timeFrame: Change from baseline to 12 weeks
measure: Body Composition
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Barnard Medical Center
state: District of Columbia
Study officials:
affiliation: Physicians Committee for Responsible Medicine
name: Vanita J Rahman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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citation: U.S. Census Bureau. Quick Facts. District of Columbia. Internet: http://www.census.gov/quickfacts/table/RHI125215/11, accessed August 22, 2016.