Hospital Workplace Nutrition Study

Overweight Clinical Trial

Official title:

Hospital Workplace Nutrition Study (Sibley Memorial Hospital)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222894
• Other study ID #: Pro00038823
• Status: Completed
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2022
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Type2 Diabetes

Intervention

Other:
• Plant-based diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
• Control Diet
Participants will be asked to continue their usual diets for the 12-week study period.

Locations

Country	Name	City	State
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine	Sibley Memorial Hospital

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Löffler A, Luck T, Then FS, Sikorski C, Kovacs P, Böttcher Y, Breitfeld J, Tönjes A, Horstmann A, Löffler 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Anticipated weight-loss for intervention group compared with control group	12 weeks
Primary	Blood Pressure	Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group	12 weeks
Primary	Plasma Lipids	Anticipated changes in plasma lipid concentrations for intervention group compared with control group	12 weeks
Secondary	Hemoglobin A1c	HbA1c will be measured as an index of glycemic control.	12 weeks
Secondary	Fasting Plasma Glucose	Fasting Plasma Glucose will be measured as an index of glycemic control.	12 weeks
Secondary	Absenteeism	Absenteeism from work will be assessed by self-report at baseline and final assessments.	12 weeks
Secondary	Quality of Life: SF-36	Quality of life will be assessed using the SF-36, which is a brief health survey with 36 questions. The SF-36 provides an 8-scale profile of functional health and well-being scores, as well as psychometrically-based physical and mental health summary measures. The SF-36 is a general measure that has been administered across various age groups, disease spectra, and treatment regimens. Items on the SF-36 are scored on a scale of 0-100, with a higher score indicating better health-related quality of life.	12 weeks
Secondary	Dietary Restraint, Disinhibition, Hunger	Participants will complete an Eating Inventory form, a highly reliable 51 item questionnaire providing quantitative measures of dietary restraint (21 questions), disinhibition (16 items), and hunger (14 questions). Scores for each sub-scale are calculated by summing respective items. The scale consists of 36 true=false items and 15 forced-choice format questions. Higher scores are indicative of greater dietary restraint, disinhibition and hunger. Its principal use in the current study will be as a gauge of ease in adapting to the intervention diet, which is indicated by changes in restraint and hunger scores.	12 weeks
Secondary	Food Acceptability: The Food Acceptability Questionnaire	The Food Acceptability Questionnaire will measure attitudes about the intervention diet, including desire to adhere, likelihood to adhere in the future, and attitudes about accessibility of sustaining the diet. Items on the FAQ are scored on a scale of 1-7. Higher scores indicate greater food acceptability.	12 weeks