Hospital Workplace Nutrition Study

NCT ID: NCT04222894

Last Updated: 2022-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-26

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Using a randomized controlled trial design, participants will be randomly assigned to either a plant-based or a control diet for 12 weeks. T Before and after each intervention period, the investigators will measure participant body weight, blood pressure, and plasma lipid concentrations.

Conditions

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Overweight Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plant-based diet

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

Group Type ACTIVE_COMPARATOR

Plant-based diet

Intervention Type OTHER

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

Control diet

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

Group Type ACTIVE_COMPARATOR

Control Diet

Intervention Type OTHER

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

Interventions

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Plant-based diet

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

Intervention Type OTHER

Control Diet

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

Intervention Type OTHER

Other Intervention Names

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Vegan diet

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
2. Smoking during the past six months
3. 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
4. Current or unresolved past drug abuse
5. Pregnancy or plans to become pregnant in the next 12 weeks
6. Intention to leave hospital employment in the next 12 weeks
7. Unstable medical or psychiatric status
8. Evidence of an eating disorder
9. Lack of English fluency
10. Inability to maintain current medication regimen
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Physicians Committee for Responsible Medicine

OTHER

Sponsor Role lead

Sibley Memorial Hospital

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal D Barnard, MD

Role: PRINCIPAL_INVESTIGATOR

President

Locations

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Sibley Memorial Hospital

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

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12365955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15199035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24512862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26422242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30613543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29200450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22262162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10760336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24566947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16873779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10496449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7500065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1973470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19562864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4337382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26230264 (View on PubMed)

Other Identifiers

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Pro00038823

Identifier Type: -

Identifier Source: org_study_id

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