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

Primary Purpose

Weight Loss, Blood Pressure, Lipid Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-fat plant-based diet
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring weight loss, body composition, lipids, hemoglobin A1c, blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Barnard Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Low-fat plant-based diet

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood pressure
Blood pressure will be measured using an automated oscillometric device.
Plasma cholesterol and triacylglycerol concentrations
Will be measured using standard methods.
hemoglobin A1c
will be measured using standard methods.
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.

Full Information

First Posted
September 13, 2019
Last Updated
February 22, 2023
Sponsor
Physicians Committee for Responsible Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04091516
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Blood Pressure, Lipid Disorder, PreDiabetes, Diabete Mellitus
Keywords
weight loss, body composition, lipids, hemoglobin A1c, blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective interventional study without a control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-fat plant-based diet
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-fat plant-based diet
Intervention Description
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 Measure Information:
Title
Weight loss
Description
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.
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure will be measured using an automated oscillometric device.
Time Frame
Change from baseline to 12 weeks
Title
Plasma cholesterol and triacylglycerol concentrations
Description
Will be measured using standard methods.
Time Frame
Change from baseline to 12 weeks
Title
hemoglobin A1c
Description
will be measured using standard methods.
Time Frame
Change from baseline to 12 weeks
Title
Body Composition
Description
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.
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanita J Rahman, MD
Organizational Affiliation
Physicians Committee for Responsible Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnard Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will make individual data available to other researchers upon request
IPD Sharing Time Frame
December 31, 2020
IPD Sharing Access Criteria
Will make study data available upon request
Citations:
PubMed Identifier
19351712
Citation
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.
Results Reference
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PubMed Identifier
25620754
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.
Results Reference
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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
Results Reference
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Citation
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.
Results Reference
background
PubMed Identifier
12778049
Citation
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.
Results Reference
background
PubMed Identifier
15286527
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.
Results Reference
background
PubMed Identifier
19167953
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.
Results Reference
background
PubMed Identifier
7842153
Citation
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.
Results Reference
background
Citation
Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.
Results Reference
background
Citation
U.S. Census Bureau. Quick Facts. District of Columbia. Internet: http://www.census.gov/quickfacts/table/RHI125215/11, accessed August 22, 2016.
Results Reference
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Feasibility & Implementation of a Plant-Based Weight-Loss Program in an Office-Based Setting

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