NCT04222894

Brief Summary

The purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 26, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

January 7, 2020

Last Update Submit

April 18, 2022

Conditions

OverweightType2 Diabetes

Keywords

body weightblood pressurelipidsnutrition

Outcome Measures

Primary Outcomes (3)

  • Body Weight

    Anticipated weight-loss for intervention group compared with control group

    12 weeks

  • Blood Pressure

    Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group

    12 weeks

  • Plasma Lipids

    Anticipated changes in plasma lipid concentrations for intervention group compared with control group

    12 weeks

Secondary Outcomes (6)

  • Hemoglobin A1c

    12 weeks

  • Fasting Plasma Glucose

    12 weeks

  • Absenteeism

    12 weeks

  • Quality of Life: SF-36

    12 weeks

  • Dietary Restraint, Disinhibition, Hunger

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Plant-based diet

ACTIVE COMPARATOR

The diet group will be asked to follow a low-fat, vegan diet for 12 weeks

Other: Plant-based diet

Control diet

ACTIVE COMPARATOR

Half of the participants will be asked to continue their usual diets for the 12-week study period.

Other: Control Diet

Interventions

Plant-based dietOTHER

Weekly instructions will be given to the participants in the intervention group about following vegan diet.

Also known as: Vegan diet
Plant-based diet
Control DietOTHER

Participants will be asked to continue their usual diets for the 12-week study period.

Control diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employee of Sibley hospital
  • Male or female
  • Age at least 18 years
  • Have a BMI \>25 kg/m2
  • Ability and willingness to participate in all components of the study
  • A willingness to follow a plant-based diet for the duration of the study
  • A willingness to attend weekly classes for the duration of the study
  • A willingness to keep physical activity level consistent throughout the duration of the study

You may not qualify if:

  • Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
  • Smoking during the past six months
  • Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
  • Current or unresolved past drug abuse
  • Pregnancy or plans to become pregnant in the next 12 weeks
  • Intention to leave hospital employment in the next 12 weeks
  • Unstable medical or psychiatric status
  • Evidence of an eating disorder
  • Lack of English fluency
  • Inability to maintain current medication regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sibley Memorial Hospital

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

Location

Related Publications (16)

  • Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.

    PMID: 12365955BACKGROUND

  • Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.

    PMID: 15199035BACKGROUND

  • Luckhaupt SE, Cohen MA, Li J, Calvert GM. Prevalence of obesity among U.S. workers and associations with occupational factors. Am J Prev Med. 2014 Mar;46(3):237-48. doi: 10.1016/j.amepre.2013.11.002.

    PMID: 24512862BACKGROUND

  • Dayoub E, Jena AB. Chronic Disease Prevalence and Healthy Lifestyle Behaviors Among US Health Care Professionals. Mayo Clin Proc. 2015 Dec;90(12):1659-62. doi: 10.1016/j.mayocp.2015.08.002. Epub 2015 Oct 5.

    PMID: 26422242BACKGROUND

  • Vibhute NA, Baad R, Belgaumi U, Kadashetti V, Bommanavar S, Kamate W. Dietary habits amongst medical students: An institution-based study. J Family Med Prim Care. 2018 Nov-Dec;7(6):1464-1466. doi: 10.4103/jfmpc.jfmpc_154_18.

    PMID: 30613543BACKGROUND

  • Bergeron N, Al-Saiegh S, Ip EJ. An Analysis of California Pharmacy and Medical Students' Dietary and Lifestyle Practices. Am J Pharm Educ. 2017 Oct;81(8):5956. doi: 10.5688/ajpe5956.

    PMID: 29200450BACKGROUND

  • Bleich SN, Bennett WL, Gudzune KA, Cooper LA. Impact of physician BMI on obesity care and beliefs. Obesity (Silver Spring). 2012 May;20(5):999-1005. doi: 10.1038/oby.2011.402. Epub 2012 Jan 19.

    PMID: 22262162BACKGROUND

  • Barnard ND, Scialli AR, Bertron P, Hurlock D, Edmonds K, Talev L. Effectiveness of a low-fat vegetarian diet in altering serum lipids in healthy premenopausal women. Am J Cardiol. 2000 Apr 15;85(8):969-72. doi: 10.1016/s0002-9149(99)00911-x.

    PMID: 10760336BACKGROUND

  • Yokoyama Y, Nishimura K, Barnard ND, Takegami M, Watanabe M, Sekikawa A, Okamura T, Miyamoto Y. Vegetarian diets and blood pressure: a meta-analysis. JAMA Intern Med. 2014 Apr;174(4):577-87. doi: 10.1001/jamainternmed.2013.14547.

    PMID: 24566947BACKGROUND

  • Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.

    PMID: 16873779BACKGROUND

  • Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.

    PMID: 10496449BACKGROUND

  • Esselstyn CB Jr, Ellis SG, Medendorp SV, Crowe TD. A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice. J Fam Pract. 1995 Dec;41(6):560-8.

    PMID: 7500065BACKGROUND

  • Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.

    PMID: 1973470BACKGROUND

  • Craig WJ, Mangels AR; American Dietetic Association. Position of the American Dietetic Association: vegetarian diets. J Am Diet Assoc. 2009 Jul;109(7):1266-82. doi: 10.1016/j.jada.2009.05.027.

    PMID: 19562864BACKGROUND

  • Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.

    PMID: 4337382BACKGROUND

  • Loffler A, Luck T, Then FS, Sikorski C, Kovacs P, Bottcher Y, Breitfeld J, Tonjes A, Horstmann A, Loffler M, Engel C, Thiery J, Villringer A, Stumvoll M, Riedel-Heller SG. Eating Behaviour in the General Population: An Analysis of the Factor Structure of the German Version of the Three-Factor-Eating-Questionnaire (TFEQ) and Its Association with the Body Mass Index. PLoS One. 2015 Jul 31;10(7):e0133977. doi: 10.1371/journal.pone.0133977. eCollection 2015.

    PMID: 26230264BACKGROUND

MeSH Terms

Conditions

OverweightBody Weight

Interventions

Diet, Plant-BasedDiet, Vegan

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, Vegetarian

Study Officials

  • Neal D Barnard, MD

    President

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 10, 2020

Study Start

June 26, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations

US(1)