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

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ClinicalTrials.gov Identifier: NCT04091516
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091516


Contacts
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Contact: Vanita J Rahman, MD 202-527-7500 vrahman@pcrm.org

Locations
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United States, District of Columbia
Barnard Medical Center Recruiting
Washington, District of Columbia, United States, 20016
Contact: Vanita J Rahman, MD    202-527-7500    vrahman@pcrm.org   
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
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Principal Investigator: Vanita J Rahman, MD Physicians Committee for Responsible Medicine

Publications:
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.
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.

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Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT04091516     History of Changes
Other Study ID Numbers: Pro00037092
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
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

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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:
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Prediabetic State
Lipid Metabolism Disorders
Diabetes Mellitus
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases