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

NCT04091516 | Unknown DMC

• 1 other identifier: Pro00037092
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Blood Pressure; Lipid Disorder; PreDiabetes; Diabete Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Blood pressure

  Change from baseline to 12 weeks

• Plasma cholesterol and triacylglycerol concentrations

  Change from baseline to 12 weeks

• hemoglobin A1c

  Change from baseline to 12 weeks

• Body Composition

  Change from baseline to 12 weeks

Study Arms (1)

Low-fat plant-based diet

OTHER

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

Interventions

Low-fat plant-based diet BEHAVIORAL

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.

Low-fat plant-based diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age ≥18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Barnard Medical Center

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (10)

• 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.

  PMID: 19351712 BACKGROUND

• 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.

  PMID: 25620754 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12778049 BACKGROUND

• 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.

  PMID: 15286527 BACKGROUND

• 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.

  PMID: 19167953 BACKGROUND

• 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.

  PMID: 7842153 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Weight Loss; Lipid Metabolism Disorders; Prediabetic State; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Vanita J Rahman, MD

  Physicians Committee for Responsible Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective interventional study without a control group

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: August 30, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: December 31, 2020
• Access Criteria: Will make study data available upon request

Locations

US (1)